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Quan A, Alfandre D. An Innovation Ethics Framework for Safe and Equitable Contingency Planning. THE JOURNAL OF CLINICAL ETHICS 2024; 35:237-248. [PMID: 39540644 DOI: 10.1086/732208] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/16/2024]
Abstract
AbstractThe contingency phase is a transition period between usual healthcare delivery and the activation of formalized rationing protocols under crisis standards of care. The contingency phase is defined by two simultaneous goals: avert or forestall critical scarcity of healthcare resources, and provide patient-centered care that is functionally equivalent to usual care when dynamic changes to healthcare operations are necessary to prevent hospital surge overload. Contingency measures modify the allocation of hospital space, staff, and supplies in service of these two goals. Although functionally equivalent care is theoretically possible, hospitals often cannot know a priori which alterations to space, staff, or supplies will lead to downstream effects on patient outcomes, raising ethical questions about how hospitals should institute equitable contingency measures when safety and efficacy data is limited. The current ethics literature has not sufficiently addressed these questions.
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Subedi SS, Neupane D, Lageju N. Critical View of Safety Dissection and Rouviere's Sulcus for Safe Laparoscopic Cholecystectomy: A Descriptive Study. J Laparoendosc Adv Surg Tech A 2023; 33:1081-1087. [PMID: 37844063 DOI: 10.1089/lap.2023.0262] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2023] Open
Abstract
Objective: To determine the importance of a critical view of safety (CVS) techniques and Rouviere's sulcus (RS) in laparoscopic cholecystectomy (LC) and its relation to biliary duct injuries (BDIs) and to determine the frequency and the type of RS. Design, Setting, and Participants: A descriptive study was carried out among 76 patients presenting to the surgery department of a tertiary care center in Nepal. The study population included all patients in the age group 16-80 years undergoing LC. Outcome Measures: The main outcome of interest was to calculate the percentage of BDIs along with the frequency and the type of RS. Results: A total of 76 patients were enrolled in the study, out of which 57(75%) were female patients with a male-to-female ratio of 1:3 and a mean age of 45.87 ± 15.33 years. Seventy-one (93.4%) patients were diagnosed with symptomatic gallstone disease. The CVS was achieved in 75 (98.7%) of the cases, whereas in 1 case, the CVS could not be achieved, and in the same patient routine LC was converted into open cholecystectomy owing to the difficult laparoscopic procedure. In 56 (73.7%) cases, RS was first visible to the operating surgeons after port installation, alignment, and adequate traction of the gallbladder; in 20 (26.3%) cases, RS was not originally apparent. Conclusion: According to the findings of this study and the literature's critical assessment of safety, this method will soon become a gold standard for dissecting gall bladder components. The technique needs to be extended further, especially for training purposes. Major difficulties can be avoided by identifying RS before cutting the cystic artery or duct during LC.
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Affiliation(s)
| | - Durga Neupane
- Department of Surgery, B.P. Koirala Institute of Health Sciences, Dharan, Nepal
| | - Nimesh Lageju
- Department of Surgery, B.P. Koirala Institute of Health Sciences, Dharan, Nepal
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Elser H, Bergquist JR, Li AY, Visser BC. Determinants, Costs, and Consequences of Common Bile Duct Injury Requiring Operative Repair Among Privately Insured Individuals in the United States, 2003-2020. ANNALS OF SURGERY OPEN 2023; 4:e238. [PMID: 37600869 PMCID: PMC10431520 DOI: 10.1097/as9.0000000000000238] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/19/2022] [Accepted: 12/30/2022] [Indexed: 02/05/2023] Open
Abstract
Objective Characterize the determinants, all-cause mortality risk, and healthcare costs associated with common bile duct injury (CBDI) following cholecystectomy in a contemporary patient population. Background Retrospective cohort study using nationwide patient-level commercial and Medicare Advantage claims data, 2003-2019. Beneficiaries ≥18 years who underwent cholecystectomy were identified using Current Procedure Terminology (CPT) codes. CBDI was defined by a second surgical procedure for repair within one year of cholecystectomy. Methods We estimated the association of common surgical indications and comorbidities with risk of CBDI using logistic regression; the association between CBDI and all-cause mortality using Cox proportional hazards regression; and calculated average healthcare costs associated with CBDI repair. Results Among 769,782 individuals with cholecystectomy, we identified 894 with CBDI (0.1%). CBDI was inversely associated with biliary colic (odds ratio [OR] = 0.82; 95% confidence interval [CI]: 0.71-0.94) and obesity (OR = 0.70, 95% CI: 0.59-0.84), but positively associated with pancreas disease (OR = 2.16, 95% CI: 1.92-2.43) and chronic liver disease (OR = 1.25, 95% CI: 1.05-1.49). In fully adjusted Cox models, CBDI was associated with increased all-cause mortality risk (hazard ratio = 1.57, 95% CI: 1.38-1.79). The same-day CBDI repair was associated with the lowest mean overall costs, with the highest mean overall costs for repair within 1 to 3 months. Conclusions In this retrospective cohort study, calculated rates of CBDI are substantially lower than in prior large studies, perhaps reflecting quality-improvement initiatives over the past two decades. Yet, CBDI remains associated with increased all-cause mortality risks and significant healthcare costs. Patient-level characteristics may be important determinants of CBDI and warrant ongoing examination in future research.
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Affiliation(s)
- Holly Elser
- From the Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia, PA
| | - John R. Bergquist
- Department of General Surgery, Stanford University School of Medicine, Stanford, CA
| | - Amy Y. Li
- Department of General Surgery, Stanford University School of Medicine, Stanford, CA
| | - Brendan C. Visser
- Department of General Surgery, Stanford University School of Medicine, Stanford, CA
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Eryigit Ö, van de Graaf FW, Nieuwenhuijs VB, Sosef MN, de Graaf EJR, Menon AG, Lange MM, Lange JF. Association of Video Completed by Audio in Laparoscopic Cholecystectomy With Improvements in Operative Reporting. JAMA Surg 2021; 155:617-623. [PMID: 32432660 DOI: 10.1001/jamasurg.2020.0741] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/23/2022]
Abstract
Importance All events that transpire during laparoscopic cholecystectomy (LC) cannot be adequately reproduced in the operative note. Video recording is already known to add important information regarding this operation. Objective It is hypothesized that additional audio recordings can provide an even better procedural understanding by capturing the surgeons' considerations. Design, Setting, and Participants The Simultaneous Video and Audio Recording of Laparoscopic Cholecystectomy Procedures (SONAR) trial is a multicenter prospective observational trial conducted in the Netherlands in which operators were requested to dictate essential steps of LC. Elective LCs of patients 18 years and older were eligible for inclusion. Data collection occurred from September 18, 2018, to November 13, 2018. Main Outcomes and Measures Adequacy rates for video recordings and operative note were compared. Adequacy was defined as the competent depiction of a surgical step and expressed as the number of adequate steps divided by the total applicable steps for all cases. In case of discrepancies, in which a step was adequately observed in the video recording but inadequately reported in the operative note, an expert panel analyzed the added value of the audio recording to resolve the discrepancy. Results A total of 79 patients (49 women [62.0%]; mean [SD] age, 54.3 [15.9] years) were included. Video recordings resulted in higher adequacy for the inspection of the gallbladder (note, 39 of 79 cases [49.4%] vs video, 79 of 79 cases [100%]; P < .001), the inspection of the liver condition (note, 17 of 79 [21.5%] vs video, 78 of 79 cases [98.7%]; P < .001), and the circumferential dissection of the cystic duct and the cystic artery (note, 25 of 77 [32.5%] vs video, 62 of 77 [80.5%]; P < .001). The total adequacy was higher for the video recordings (note, 849 of 1089 observations [78.0%] vs video, 1005 of 1089 observations [92.3%]; P < .001). In the cases of discrepancies between video and note, additional audio recordings lowered discrepancy rates for the inspection of the gallbladder (without audio, 40 of 79 cases [50.6%] vs with audio, 17 of 79 cases [21.5%]; P < .001), the inspection of the liver condition (without audio, 61 of 79 [77.2%] vs with audio, 37 of 79 [46.8%]; P < .001), the circumferential dissection of the cystic duct and the cystic artery (without audio, 43 of 77 cases [55.8%] vs with audio, 17 of 77 cases [22.1%]; P < .001), and similarly for the removal of the first accessory trocar (without audio, 27 of 79 [34.2%] vs with audio, 16 of 79 [20.3%]; P = .02), the second accessory trocar (without audio, 24 of 79 [30.4%] vs with audio, 11 of 79 [13.9%]; P < .001), and the third accessory trocar (without audio, 27 of 79 [34.2%] vs with audio, 14 of 79 [17.7%]; P < .001). The total discrepancy was lower with audio adjustment (without audio, 254 of 1089 observations [23.3%] vs with audio, 128 of 1089 observations [11.8%]; P < .001). Conclusions and Relevance Audio recording during LC significantly improves the adequacy of depicting essential surgical steps and exhibits lower discrepancies between video and operative note.
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Affiliation(s)
- Özgür Eryigit
- Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands
| | - Floyd W van de Graaf
- Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands
| | | | - Meindert N Sosef
- Department of Surgery, Zuyderland Medical Center, Sittard-Geleen and Heerlen, the Netherlands
| | | | - Anand G Menon
- Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands
| | - Marilyne M Lange
- Department of Pathology, Amsterdam University Medical Center, VU University Medical Center, Amsterdam, the Netherlands
| | - Johan F Lange
- Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands
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Does near-infrared fluorescent cholangiography with indocyanine green reduce bile duct injuries and conversions to open surgery during laparoscopic or robotic cholecystectomy? - A meta-analysis. Surgery 2021; 169:859-867. [PMID: 33478756 DOI: 10.1016/j.surg.2020.12.008] [Citation(s) in RCA: 42] [Impact Index Per Article: 10.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/07/2020] [Revised: 11/10/2020] [Accepted: 12/07/2020] [Indexed: 12/20/2022]
Abstract
BACKGROUND Bile duct injury and conversion-to-open-surgery rates remain unacceptably high during laparoscopic and robotic cholecystectomy. In a recently published randomized clinical trial, using near-infrared fluorescent cholangiography with indocyanine green intraoperatively markedly enhanced biliary-structure visualization. Our systematic literature review compares bile duct injury and conversion-to-open-surgery rates in patients undergoing laparoscopic or robotic cholecystectomy with versus without near-infrared fluorescent cholangiography. METHODS A thorough PubMed search was conducted to identify randomized clinical trials and nonrandomized clinical trials with ≥100 patients. Because all near-infrared fluorescent cholangiography studies were published since 2013, only studies without near-infrared fluorescent cholangiography published since 2013 were included for comparison. Incidence estimates, weighted and unweighted for study size, were adjusted for acute versus chronic cholecystitis, and for robotic versus laparoscopic cholecystectomy and are reported as events/10,000 patients. All studies were assessed for bias risk and high-risk studies excluded. RESULTS In total, 4,990 abstracts were reviewed, identifying 5 near-infrared fluorescent cholangiography studies (3 laparoscopic cholecystectomy/2 robotic cholecystectomy; n = 1,603) and 11 not near-infrared fluorescent cholangiography studies (5 laparoscopic cholecystectomy/4 robotic cholecystectomy/2 both; n = 5,070) for analysis. Overall weighted rates for bile duct injury and conversion were 6 and 16/10,000 in near-infrared fluorescent cholangiography patients versus 25 and 271/10,000 in patients without near-infrared fluorescent cholangiography. Among patients undergoing laparoscopic cholecystectomy, bile duct injuries, and conversion rates among near-infrared fluorescent cholangiography versus patients without near-infrared fluorescent cholangiography were 0 and 23/10,000 versus 32 and 255/10,000, respectively. Bile duct injury rates were low with robotic cholecystectomy with and without near-infrared fluorescent cholangiography (12 and 8/10,000), but there was a marked reduction in conversions with near-infrared fluorescent cholangiography (12 vs 322/10,000). CONCLUSION Although large comparative trials remain necessary, preliminary analysis suggests that using near-infrared fluorescent cholangiography with indocyanine green intraoperatively sizably decreases bile duct injury and conversion-to-open-surgery rates relative to cholecystectomy under white light alone.
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Brown K, Solomon MJ, Young J, Seco M, Bannon PG. Addressing the ethical grey zone in surgery: a framework for identification and safe introduction of novel surgical techniques and procedures. ANZ J Surg 2019; 89:634-638. [PMID: 30974516 DOI: 10.1111/ans.15104] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/15/2018] [Revised: 01/07/2019] [Accepted: 01/09/2019] [Indexed: 11/29/2022]
Abstract
While the introduction of new surgical techniques can radically improve patient care, they may equally expose patients to unforeseen harms associated with untested procedures. The enthusiastic uptake of laparoscopic cholecystectomy in the early 1990s saw a dramatic increase in the rate of common bile duct injuries, and was described by Alfred Cuschieri as 'the biggest unaudited free-for-all in the history of surgery' due to 'a lack of effective centralised control'. Whether a new surgical intervention is considered an acceptable 'minor' variation of an established procedure, or is sufficiently 'novel' to constitute experimentation on human subjects is often unclear. Furthermore, once a new technique is identified as experimental, there is no agreed protocol for safety evaluation in a first-in-human setting. In phase I (first-in-human) pharmacological trials only small, single arm cohorts of highly selected patients are enrolled in order to establish the safety profile of a new drug. This exposes only a small number of patients to the unknown or unforeseen risks that may be associated with a new agent, in a highly regulated and scientifically rigorous manner. There is no equivalent study design for the introduction of new and experimental surgical procedures. This article proposes a practical stepwise approach to the safe introduction of new surgical procedures that surgeons and surgical departments can adopt. It includes criteria for new surgical techniques which require formal prospective ethical evaluation, and a novel study design for conducting a safety evaluation at the 'first in human' stage.
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Affiliation(s)
- Kilian Brown
- Surgical Outcomes Research Centre (SOuRCe), Sydney, New South Wales, Australia.,Institute of Academic Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.,Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
| | - Michael J Solomon
- Surgical Outcomes Research Centre (SOuRCe), Sydney, New South Wales, Australia.,Institute of Academic Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.,Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.,The University of Sydney, Sydney, New South Wales, Australia
| | - Jane Young
- Surgical Outcomes Research Centre (SOuRCe), Sydney, New South Wales, Australia.,Institute of Academic Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.,The University of Sydney, Sydney, New South Wales, Australia
| | - Michael Seco
- The University of Sydney, Sydney, New South Wales, Australia.,Department of Cardiothoracic Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
| | - Paul G Bannon
- Institute of Academic Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.,The University of Sydney, Sydney, New South Wales, Australia.,Department of Cardiothoracic Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
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Safe laparoscopic cholecystectomy: A systematic review of bile duct injury prevention. Int J Surg 2018; 60:164-172. [PMID: 30439536 DOI: 10.1016/j.ijsu.2018.11.006] [Citation(s) in RCA: 55] [Impact Index Per Article: 7.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2018] [Revised: 10/14/2018] [Accepted: 11/04/2018] [Indexed: 12/13/2022]
Abstract
BACKGROUND Since the introduction of laparoscopic cholecystectomy (LC), a substantial increase in bile duct injury (BDI) incidence was noted. Multiple methods to prevent this complication have been developed and investigated. The most suitable method however is subject to debate. In this systematic review, the different modalities to aid in the safe performance of LC and prevent BDI are delineated. MATERIALS AND METHODS A systematic search for articles describing methods for the prevention of BDI in LC was conducted using EMBASE, Medline, Web of science, Cochrane CENTRAL and Google scholar databases from inception to 11 June 2018. RESULTS 90 studies were included in this systematic review. Overall, BDI preventive techniques can be categorized as dedicated surgical approaches (Critical View of Safety (CVS), fundus first, partial laparoscopic cholecystectomy), supporting imaging techniques (intraoperative radiologic cholangiography, intraoperative ultrasonography, fluorescence imaging) and others. Dedicated surgical approaches demonstrate promising results, yet limited research is provided. Intraoperative radiologic cholangiography and ultrasonography demonstrate beneficial effects in BDI prevention, however the available evidence is low. Fluorescence imaging is in its infancy, yet this technique is demonstrated to be feasible and larger trials are in preparation. CONCLUSION Given the low sample sizes and suboptimal study designs of the studies available, it is not possible to recommend a preferred method to prevent BDI. Surgeons should primarily focus on proper dissection techniques, of which CVS is most suitable. Additionally, recognition of hazardous circumstances and knowledge of alternative techniques is critical to complete surgery with minimal risk of injury to the patient.
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Cha J, Broch A, Mudge S, Kim K, Namgoong JM, Oh E, Kim P. Real-time, label-free, intraoperative visualization of peripheral nerves and micro-vasculatures using multimodal optical imaging techniques. BIOMEDICAL OPTICS EXPRESS 2018; 9. [PMID: 29541506 PMCID: PMC5846516 DOI: 10.1364/boe.9.001097] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/14/2023]
Abstract
Accurate, real-time identification and display of critical anatomic structures, such as the nerve and vasculature structures, are critical for reducing complications and improving surgical outcomes. Human vision is frequently limited in clearly distinguishing and contrasting these structures. We present a novel imaging system, which enables noninvasive visualization of critical anatomic structures during surgical dissection. Peripheral nerves are visualized by a snapshot polarimetry that calculates the anisotropic optical properties. Vascular structures, both venous and arterial, are identified and monitored in real-time using a near-infrared laser-speckle-contrast imaging. We evaluate the system by performing in vivo animal studies with qualitative comparison by contrast-agent-aided fluorescence imaging.
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Affiliation(s)
- Jaepyeong Cha
- Sheikh Zyaed Institute for Pediatric Surgical Innovation, Children's National Health System, 111 Michigan Avenue NW, Washington, DC 20010, USA
- These authors contributed equally to this work
| | - Aline Broch
- Sheikh Zyaed Institute for Pediatric Surgical Innovation, Children's National Health System, 111 Michigan Avenue NW, Washington, DC 20010, USA
- These authors contributed equally to this work
| | - Scott Mudge
- Sheikh Zyaed Institute for Pediatric Surgical Innovation, Children's National Health System, 111 Michigan Avenue NW, Washington, DC 20010, USA
| | - Kihoon Kim
- Sheikh Zyaed Institute for Pediatric Surgical Innovation, Children's National Health System, 111 Michigan Avenue NW, Washington, DC 20010, USA
- Department of Surgery, Inje University Haeundae Paik Hospital, 875 Haeun-daero, Haeundae-gu, Busan 612-896, South Korea
| | - Jung-Man Namgoong
- Sheikh Zyaed Institute for Pediatric Surgical Innovation, Children's National Health System, 111 Michigan Avenue NW, Washington, DC 20010, USA
- Department of Surgery, Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, South Korea
| | - Eugene Oh
- Sheikh Zyaed Institute for Pediatric Surgical Innovation, Children's National Health System, 111 Michigan Avenue NW, Washington, DC 20010, USA
- Department of Biomedical Engineering, The Johns Hopkins University, 3400 N. Charles Street, Baltimore, MD 21218, USA
| | - Peter Kim
- Sheikh Zyaed Institute for Pediatric Surgical Innovation, Children's National Health System, 111 Michigan Avenue NW, Washington, DC 20010, USA
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Antiel RM, Flake AW. Responsible surgical innovation and research in maternal-fetal surgery. Semin Fetal Neonatal Med 2017; 22:423-427. [PMID: 28551276 DOI: 10.1016/j.siny.2017.05.002] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
The field of maternal-fetal intervention is rapidly evolving with new technologies and innovations. This raises complex ethical and medico-legal challenges related to what constitutes innovative treatment versus human experimentation, with or without the umbrella of "medical research." There exists a gray zone between these black and white classifications, but there are also clear guidelines that should be responsibly negotiated when making the essential transition between an innovative treatment and a validated therapy. This review attempts to define some of the current and future ethical challenges in maternal-fetal research, and to offer constructive insight into how they might be addressed.
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Affiliation(s)
- Ryan M Antiel
- Department of General, Thoracic and Fetal Surgery, Center for Fetal Diagnosis and Therapy, Children's Hospital of Philadelphia, Philadelphia, PA, USA; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Philadelphia, PA, USA
| | - Alan W Flake
- Department of General, Thoracic and Fetal Surgery, Center for Fetal Diagnosis and Therapy, Children's Hospital of Philadelphia, Philadelphia, PA, USA; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Philadelphia, PA, USA.
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Toker A. ESTS Presidential Address - Creative destruction: a new era in the field of thoracic surgery. Eur J Cardiothorac Surg 2015; 48:519-23. [PMID: 26245627 DOI: 10.1093/ejcts/ezv266] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/13/2022] Open
Affiliation(s)
- Alper Toker
- Department of Thoracic Surgery, Istanbul University Istanbul Medical School, Istanbul, Turkey Department of Thoracic Surgery, Group Florence Nightingale Hospitals, Istanbul, Turkey
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Abstract
Innovation is responsible for most advances in the field of surgery. Innovative approaches to solving clinical problems have significantly decreased morbidity and mortality for many surgical procedures, and have led to improved patient outcomes. While innovation is motivated by the surgeon's expectation that the new approach will be beneficial to patients, not all innovations are successful or result in improved patient care. The ethical dilemma of surgical innovation lies in the uncertainty of whether a particular innovation will prove to be a "good thing." This uncertainty creates challenges for surgeons, patients, and the healthcare system. By its very nature, innovation introduces a potential risk to patient safety, a risk that may not be fully known, and it simultaneously fosters an optimism bias. These factors increase the complexity of informed consent and shared decision making for the surgeon and the patient. Innovative procedures and their associated technology raise issues of cost and resource distribution in the contemporary, financially conscious, healthcare environment. Surgeons and institutions must identify and address conflicts of interest created by the development and application of an innovation, always preserving the best interest of the patient above the academic or financial rewards of success. Potential strategies to address the challenges inherent in surgical innovation include collecting and reporting objective outcomes data, enhancing the informed consent process, and adhering to the principles of disclosure and professionalism. As surgeons, we must encourage creativity and innovation while maintaining our ethical awareness and responsibility to patients.
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Affiliation(s)
- Megan E Miller
- Department of Surgery, The University of Chicago Medicine, 5841 S. Maryland Avenue, MC6040, Chicago, IL, 60637, USA,
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Ljubičić N, Bišćanin A, Pavić T, Nikolić M, Budimir I, Mijić A, Đuzel A. Biliary leakage after urgent cholecystectomy: Optimization of endoscopic treatment. World J Gastrointest Endosc 2015; 7:547-554. [PMID: 25992194 PMCID: PMC4436923 DOI: 10.4253/wjge.v7.i5.547] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/22/2014] [Revised: 12/30/2014] [Accepted: 03/09/2015] [Indexed: 02/05/2023] Open
Abstract
AIM: To investigate the results of endoscopic treatment of postoperative biliary leakage occurring after urgent cholecystectomy with a long-term follow-up.
METHODS: This is an observational database study conducted in a tertiary care center. All consecutive patients who underwent endoscopic retrograde cholangiography (ERC) for presumed postoperative biliary leakage after urgent cholecystectomy in the period between April 2008 and April 2013 were considered for this study. Patients with bile duct transection and biliary strictures were excluded. Biliary leakage was suspected in the case of bile appearance from either percutaneous drainage of abdominal collection or abdominal drain placed at the time of cholecystectomy. Procedural and main clinical characteristics of all consecutive patients with postoperative biliary leakage after urgent cholecystectomy, such as indication for cholecystectomy, etiology and type of leakage, ERC findings and post-ERC complications, were collected from our electronic database. All patients in whom the leakage was successfully treated endoscopically were followed-up after they were discharged from the hospital and the main clinical characteristics, laboratory data and common bile duct diameter were electronically recorded.
RESULTS: During a five-year period, biliary leakage was recognized in 2.2% of patients who underwent urgent cholecystectomy. The median time from cholecystectomy to ERC was 6 d (interquartile range, 4-11 d). Endoscopic interventions to manage biliary leakage included biliary stent insertion with or without biliary sphincterotomy. In 23 (77%) patients after first endoscopic treatment bile flow through existing surgical drain ceased within 11 d following biliary therapeutic endoscopy (median, 4 d; interquartile range, 2-8 d). In those patients repeat ERC was not performed and the biliary stent was removed on gastroscopy. In seven (23%) patients repeat ERC was done within one to fourth week after their first ERC, depending on the extent of the biliary leakage. In two of those patients common bile duct stone was recognized and removed. Three of those seven patients had more complicated clinical course and they were referred to surgery and were excluded from long-term follow-up. The median interval from endoscopic placement of biliary stent to demonstration of resolution of bile leakage for ERC treated patients was 32 d (interquartile range, 28-43 d). Among the patients included in the follow-up (median 30.5 mo, range 7-59 mo), four patients (14.8%) died of severe underlying comorbid illnesses.
CONCLUSION: Our results demonstrate the great efficiency of the endoscopic therapy in the treatment of the patients with biliary leakage after urgent cholecystectomy.
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Abstract
The future of surgical progress depends on surgeons finding innovative solutions to their patients' problems. Surgical innovation is critical to advances in surgery. However, surgical innovation also raises a series of ethical issues that challenge the professionalism of surgeons. The very criteria for defining surgical progress have changed as patients may value more than simply reductions in morbidity and mortality. The requirement for informed consent prior to surgery is difficult when an innovative surgical procedure is planned since the risks of the novel operation may not be known. In addition, even if the risks are known in the hands of the innovator, the actual risks to patients when surgeons are learning the new technique are unknown. New techniques often depend on new technology which may be significantly more expensive than traditional techniques. There are no clear criteria to decide which new innovative techniques are going to turn out to be truly beneficial to patients. Many surgical innovations depend on new products which may have been developed as collaborative efforts between surgical device companies and surgeons. Although many currently accepted therapies were developed in this fashion, the collaboration of surgeons and device companies raises the potential for significant harmful conflicts of interest. In the decades to come, careful attention to these and other ethical issues will help to define the future professional standing of surgeons.
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Affiliation(s)
- Peter Angelos
- Linda Kohler Anderson Professor of Surgery and Surgical Ethics, Chief, Endocrine Surgery, Associate Director, MacLean Center for Clinical Medical Ethics, The University of Chicago, USA
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Namm JP, Siegler M, Brander C, Kim TY, Lowe C, Angelos P. History and Evolution of Surgical Ethics: John Gregory to the Twenty-first Century. World J Surg 2014; 38:1568-73. [DOI: 10.1007/s00268-014-2584-1] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/12/2023]
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Lokesh HM, Pottakkat B, Prakash A, Singh RK, Behari A, Kumar A, Kapoor VK, Saxena R. Risk factors for development of biliary stricture in patients presenting with bile leak after cholecystectomy. Gut Liver 2013; 7:352-6. [PMID: 23710318 PMCID: PMC3661969 DOI: 10.5009/gnl.2013.7.3.352] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/01/2011] [Revised: 04/08/2012] [Accepted: 04/26/2012] [Indexed: 12/13/2022] Open
Abstract
Background/Aims This study was aimed at determining the factors associated with the development of benign biliary stricture (BBS) in patients who had sustained a bile duct injury (BDI) at cholecystectomy and developed bile leaks. Methods A retrospective analysis of 214 patients with BDI who were referred to our center between January 1989 and December 2009 was done. Results One hundred fifty-three (71%) patients developed BBS (group I), and 61 (29%) were normal (group II). By univariate analysis, female gender (p=0.02), open cholecystectomy as the index operation (p=0.0001), delay in the referral from identification of injury (p=0.04), persistence of an external biliary fistula (EBF) beyond 4 weeks (p=0.0001), EBF output >400 mL (p=0.01), presence of jaundice (p=0.0001), raised serum total bilirubin level (p=0.0001), raised serum alkaline phosphatase level (p=0.0001), and complete BDI (p=0.0001) were associated with the development of BBS. Furthermore, open cholecystectomy as the index operation (p=0.04), delayed referral (p=0.02), persistent EBF (p=0.03), and complete BDI (p=0.001) were found to predict patient outcome in the multivariate analysis. Conclusions For the majority of patients with BDI, the risk of developing BBS could have been predicted at the initial presentation.
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Affiliation(s)
- Hosur Mayanna Lokesh
- Department of Surgical Gastroenterology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India
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Single incision laparoscopic cholecystectomy and the introduction of innovative surgical procedures. Ann Surg 2012; 256:7-9. [PMID: 22751515 DOI: 10.1097/sla.0b013e31825b381a] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
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Carraro A, Mazloum DE, Bihl F. Health-related quality of life outcomes after cholecystectomy. World J Gastroenterol 2011; 17:4945-51. [PMID: 22174543 PMCID: PMC3236586 DOI: 10.3748/wjg.v17.i45.4945] [Citation(s) in RCA: 25] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/23/2010] [Revised: 06/15/2011] [Accepted: 06/22/2011] [Indexed: 02/06/2023] Open
Abstract
Gallbladder diseases are very common in developed countries. Complicated gallstone disease represents the most frequent of biliary disorders for which surgery is regularly advocated. As regards, cholecystectomy represents a common abdominal surgical intervention; it can be performed as either an elective intervention or emergency surgery, in the case of gangrene, perforation, peritonitis or sepsis. Nowadays, the laparoscopic approach is preferred over open laparotomy. Globally, numerous cholecystectomies are performed daily; however, little evidence exists regarding assessment of post-surgical quality of life (QOL) following these interventions. To assess post-cholecystectomy QOL, in fact, documentation of high quality care has been subject to extended discussions, and the use of patient-reported outcome satisfaction for quality improvement has been advocated for several years. However, there has been little research published regarding QOL outcomes following cholecystectomy; in addition, much of the current literature lacks systematic data on patient-centered outcomes. Then, although several tools have been used to measure QOL after cholecystectomy, difficulty remains in selecting meaningful parameters in order to obtain reproducible data to reflect postoperative QOL. The aim of this study was to review the impact of surgery for gallbladder diseases on QOL. This review includes Medline searches of current literature on QOL following cholecystectomy. Most studies demonstrated that symptomatic patients profited more from surgery than patients receiving an elective intervention. Thus, the gain in QOL depends on the general conditions before surgery, and patients without symptoms profit less or may even have a reduction in QOL.
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Kasuya K, Itoi T, Matsudo T, Kyo B, Endo Y, Ikeda T, Nagakawa Y, Suzuki Y, Shimazu M, Aoki T, Tsuchida A. Reconsideration of laparoscopic cholecystectomy. ISRN SURGERY 2011; 2011:827465. [PMID: 22084777 PMCID: PMC3200264 DOI: 10.5402/2011/827465] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 04/01/2011] [Accepted: 05/04/2011] [Indexed: 12/04/2022]
Abstract
We describe the surgical method of cases showing a distended gallbladder. Because the most important thing does not cause biliary tract injury, it is to find orientation carefully. The frequency of incidental gallbladder cancer was in 7 (0.7%) of the 983. Only cholecystectomy is necessary to be performed for Tis or T1 cancer, and surgery has to be changed to radical surgery for T2 cancer or deeper invasion. Laparoscopic cholecystectomy is already an established standard operation. In the presence of acute or severe chronic inflammation, special attention should be paid to these points.
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Affiliation(s)
- Kazuhiko Kasuya
- Department of Surgery, Tokyo Medical University, 6-7-1 Nishishinjuku Shinjuku-ku, Tokyo 160-0023, Japan
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Sharma H, Bird G. Endoscopic management of postcholecystectomy biliary leaks. Frontline Gastroenterol 2011; 2:230-233. [PMID: 28839615 PMCID: PMC5517231 DOI: 10.1136/flgastro-2011-100031] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 07/03/2011] [Indexed: 02/04/2023] Open
Abstract
OBJECTIVE To evaluate the nature of bile duct injuries following cholecystectomy and the success of endoscopic retrograde cholangiopancreatography (ERCP) in their identification and management. DESIGN All patients referred for ERCP with a diagnosis of a postcholecystectomy bile leak were identified prospectively from October 1994 to August 2008. SETTING The study was carried out in a district general hospital with the endoscopies performed by a single operator. PATIENTS All patients had undergone imaging with at least two of abdominal ultrasound scanning, CT scanning or MR cholangiopancreatography. INTERVENTIONS ERCP with treatment of a biliary leak by sphincterotomy and insertion of a temporary 7 Fr plastic biliary stent. MAIN OUTCOME MEASUREMENTS Clinical healing of the injury was assessed as resolution of symptoms with normalisation of liver function tests, cessation of external drain output and a repeat ERCP with removal of the indwelling stent within 2-8 weeks and no further complications. RESULTS 46 patients were identified, of whom 42 responded well to endoscopic treatment. Four patients ultimately needed surgery, of whom three had recurrent strictures. One patient had complete transection of the biliary duct and endoscopic treatment was not attempted. CONCLUSION ERCP, with sphincterotomy and temporary plastic stent placement, is successful in the early management of patients with postcholecystectomy biliary leaks, which most commonly involve the cystic duct stump. ERCP carried out in a district general hospital identifies those patients requiring further specialised hepatobiliary care in a tertiary centre.
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Affiliation(s)
- Hemant Sharma
- Department of Medicine, Maidstone Hospital, Maidstone, UK
| | - George Bird
- Department of Medicine, Maidstone Hospital, Maidstone, UK
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Khandelwal S, Wright AS, Figueredo E, Pellegrini CA, Oelschlager BK. Single-incision laparoscopy: training, techniques, and safe introduction to clinical practice. J Laparoendosc Adv Surg Tech A 2011; 21:687-93. [PMID: 21882993 DOI: 10.1089/lap.2011.0238] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022] Open
Abstract
BACKGROUND Single-incision laparoscopy is an emerging technique that brings new challenges to laparoscopy and introduces new skills that a surgeon must learn. The learning needs for single-incision skills acquisition are unknown and no current guidelines exist for training or for its safe adoption. METHODS We developed an approach to adoption of new surgical techniques and applied it to single-incision laparoscopy. It is based on the following principles: a defined training algorithm, dry and wet-laboratory practice, a graded clinical introduction, and careful review of early outcomes. We analyzed its impact in our initial 40 patients. RESULTS Our training paradigm consisted of the following: attending a formal course, developing a simulation model, and animal laboratory training, followed by graduated clinical adoption. A 20% conversion rate to standard laparoscopy or open surgery occurred. CONCLUSION Introducing a new surgical technique may not only offer potential advantages but also present significant risks. We developed a thoughtful approach to adoption that includes simulation-based training, progressive clinical adoption, and early review of outcomes. This approach may be applied to various new clinical applications.
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Affiliation(s)
- Saurabh Khandelwal
- Department of Surgery, The Center for Videoendoscopic Surgery, The Institute for Simulation and Interprofessional Studies, University of Washington, Seattle, Washington, USA.
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22
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Allardyce RA, Bagshaw PF, Frampton CM, Frizelle FA, Hewett PJ, Rieger NA, Smith JS, Solomon MJ, Stevenson ARL. Ethical issues with the disclosure of surgical trial short-term data. ANZ J Surg 2010; 81:125-31. [DOI: 10.1111/j.1445-2197.2010.05433.x] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/12/2023]
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Coelho-Prabhu N, Baron TH. Assessment of need for repeat ERCP during biliary stent removal after clinical resolution of postcholecystectomy bile leak. Am J Gastroenterol 2010; 105:100-5. [PMID: 19773748 DOI: 10.1038/ajg.2009.546] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVES In patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP) with biliary stent placement for postcholecystectomy bile leak there is limited evidence to support the repeat ERCP at the time of stent removal. Esophagogastroduodenoscopy (EGD) with biliary stent removal may suffice. The aim of this study was to describe the clinical course of patients who underwent biliary stent placement for a postcholecystectomy bile leak and determine whether repeat ERCP is necessary. METHODS We identified all adult patients who underwent biliary stent placement for postcholecystectomy bile leak from 1 January 1996 to 31 October 2008. Demographic data, cholecystectomy details, and procedural data were collected, specifically focusing on closure of the bile leak. Time to resolution of leak was calculated, up to either the date of the first repeat ERCP that demonstrated no persistent leak or the date of removal of any radiologically placed percutaneous drain, whichever came first. RESULTS Sixty-four patients underwent repeat ERCP with biliary stent removal. The median time to repeat ERCP was 36 days (interquartile range (IQR) 26-48). Fifty-seven (89%) patients had resolved the leak by time of repeat ERCP. Of those in whom the leak had not resolved, 6 had a repeat exam within 14 days of stent placement; 4 of these resolved the leak by day 39. There were no procedure-related complications in the ERCP group. Thirteen patients underwent EGD with stent removal after a median of 29 days (IQR 23-38). None had adverse events, with a median follow-up of 38 months. Overall, the median time to resolution of biliary leak was 33 days (IQR 22-44). Importantly, repeat ERCP altered the management in only one patient in whom bile duct stones were found. CONCLUSIONS Patients with uncomplicated postcholecystectomy bile leak who have clinically resolved their leak do not require cholangiography at the time of stent removal. In these patients, EGD with stent removal at 4-6 weeks seems to be sufficient and significantly less expensive.
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Abstract
It has been suggested that the robotic surgery platform is an enabling technology that allows surgeons that are not trained in standard laparoscopy to perform minimally-invasive surgery. This raises the question of whether or not training in laparoscopy is necessary for current and future surgeons. The current status of laparoscopy in urology in the United States is reviewed along with a perspective regarding the potential future role of laparoscopic training as robotic surgery becomes increasingly applied to most major urologic procedures.
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Affiliation(s)
- Ronney Abaza
- Ohio State University Medical Center & James Cancer Hospital – Robotic Urologic Surgery, Department of Urology, Columbus, OH, USA
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25
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Hirsch NA. Diffusion and cost considerations for minimally invasive techniques in gynaecology. MINIM INVASIV THER 2009. [DOI: 10.3109/13645709409153035] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/06/2023]
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26
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Pellegrini CA, Sinanan MN. Training, proctoring, credentialing in endoscopic surgery. MINIM INVASIV THER 2009. [DOI: 10.3109/13645709709152821] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022]
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Abstract
Dexterity is a crucial aspect of surgical competence and is considered to be of high priority in the selection of trainees to specialities such as laparoscopic surgery. A motion analysis system, Imperial College Surgical Assessment Device (ICSAD) has undergone validation studies and is sensitive in discriminating surgeons according to their experience. It consists of a signal generator that creates an electromagnetic field in which sensors placed on the surgeon's hands can be detected using a special software. These positional data can be converted to data reflecting the surgeon's dexterity. It is a useful adjunct to training as trainees can be expected to achieve a certain level of proficiency prior to progress. They can also be provided with an objective feedback of their performance. As an assessment method it can be used for credentialing in laparoscopic surgery.
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28
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Hu JC, Wang Q, Pashos CL, Lipsitz SR, Keating NL. Utilization and outcomes of minimally invasive radical prostatectomy. J Clin Oncol 2008; 26:2278-84. [PMID: 18467718 DOI: 10.1200/jco.2007.13.4528] [Citation(s) in RCA: 178] [Impact Index Per Article: 10.5] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Abstract
PURPOSE Demand for minimally invasive radical prostatectomy (MIRP) to treat prostate cancer is increasing; however, outcomes remain unclear. We assessed utilization, complications, lengths of stay, and salvage therapy rates for MIRP versus open radical prostatectomy assessed whether MIRP surgeon volume is associated with better outcomes. METHODS We identified 2,702 men undergoing MIRP and open radical prostatectomy during 2003 to 2005 from a national 5% sample of Medicare beneficiaries. We assessed the association between surgical approach and outcomes, adjusting for surgeon volume, age, race, comorbidity, and geographic region. RESULTS MIRP utilization increased from 12.2% in 2003 to 31.4% in 2005. Men undergoing MIRP versus open radical prostatectomy had fewer perioperative complications (29.8% v 36.4%; P = .002) and shorter lengths of stay (1.4 v 4.4 days; P < .001); however, they were more likely to receive salvage therapy (27.8% v 9.1%, P < .001). In adjusted analyses, MIRP versus open radical prostatectomy was associated with fewer perioperative complications (odds ratio [OR], 0.73; 95% CI, 0.60 to 0.90), shorter lengths of stay (parameter estimate, -2.99; 95% CI, -3.45 to -2.53) but more anastomotic strictures (OR, 1.40; 95% CI, 1.04 to 1.87) and higher rates of salvage therapy (OR, 3.67; 95% CI, 2.81 to 4.81). Patients of high-volume MIRP experienced fewer anastomotic strictures (OR, 0.93; 95% CI, 0.87 to 0.99) and less salvage therapy (OR, 0.92; 95% CI, 0.88 to 0.98). CONCLUSION Men undergoing MIRP versus open radical prostatectomy have lower risk for perioperative complications and shorter lengths of stay, but are at higher risk for salvage therapy and anastomotic strictures. However, risk for these unfavorable outcomes decreases with increasing MIRP surgical volume.
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Affiliation(s)
- Jim C Hu
- Division of Urologic Surgery, Brigham and Women's Hospital, Boston, MA 02115, USA.
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29
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Hepatobiliary scintigraphy in detecting lesser sac bile leak in postcholecystectomy patients: the need to recognize as a separate entity. Clin Nucl Med 2008; 33:161-7. [PMID: 18287836 DOI: 10.1097/rlu.0b013e318162eb08] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
Cholecystectomy is one of the most commonly performed abdominal surgeries in which bile duct injury and bile leaks are the most important complications. Imaging plays an important role in the prompt diagnosis and management of bile leaks. The more common sites of bile leak are the gallbladder bed, subhepatic, in a bilioma, right paracolic gutter, or diffusely in the peritoneal cavity. Bile leak into the lesser sac (LS) is uncommon but is a special entity posing difficult problems in management. We have described in this study the clinical presentation, imaging findings, and management of 6 patients with biliary leakage into the LS postcholecystectomy. The clinical presentation of this condition was varied, ranging from patients with asymptomatic or with vague complaints resulting in difficulties in clinical suspicion or symptomatic but minimal enough not to be detected by ultrasonogram. Hepatobiliary scintigraphy played an important role in the diagnosis and management, and all patients required definitive therapeutic drainage procedures. Any persistent focal radiotracer activity in the anatomy of the LS, increasing with time and not diffusing into the general peritoneal cavity is diagnostic of bile leak into the LS.
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30
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Mosimann F. Avoiding misidentification injuries in laparoscopic cholecystectomy. J Am Coll Surg 2006; 204:190. [PMID: 17189139 DOI: 10.1016/j.jamcollsurg.2006.09.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2006] [Accepted: 09/14/2006] [Indexed: 11/16/2022]
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Hobbs MS, Mai Q, Knuiman MW, Fletcher DR, Ridout SC. Surgeon experience and trends in intraoperative complications in laparoscopic cholecystectomy. Br J Surg 2006; 93:844-53. [PMID: 16671070 DOI: 10.1002/bjs.5333] [Citation(s) in RCA: 103] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
BACKGROUND Intraoperative complications, particularly bile duct injuries (BDIs), have increased since the introduction of laparoscopic cholecystectomy (LC). This excess risk is expected to decline as surgeon experience in laparoscopic surgery increases. METHODS This was a population-based study of trends in intraoperative injuries in 33 309 cholecystectomies carried out in Western Australia between 1988 and 1998, based on hospital discharge abstracts. Endpoints were identified from diagnostic and procedure codes in index or postoperative readmissions, or a register of endoscopic retrograde cholangiopancreatography procedures, and validated using hospital records. Multivariate analysis was used to estimate the risk of complications associated with potential risk factors. RESULTS Following the introduction of LC in 1991, the prevalence of all complications doubled by 1994 then stabilized, whereas that of BDI declined after 1994. The risk of complications increased with age, was higher in men, teaching and country hospitals, and was higher for LC and more complicated operations. It was lower when intraoperative cholangiography was performed and with increasing surgeon experience. Approximately 20 per cent of all complications and 30 per cent of BDIs were attributable to surgeons who had performed 200 or fewer cholecystectomies in the previous 5 years. CONCLUSION The risk of intraoperative complications declined with increasing surgical experience and use of intraoperative cholangiography.
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Affiliation(s)
- M S Hobbs
- School of Population Health, University of Western Australia, Crawley, Western Australia, Australia.
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Jones RS, Richards K, Russell T. Relative contributions of surgeons and decision support systems. Surg Clin North Am 2006; 86:169-79, xi. [PMID: 16442427 DOI: 10.1016/j.suc.2005.10.017] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/19/2022]
Abstract
Evidence-based medicine came into focus in 1992 when scholars recognized the need for valid information required for optimal patient care. Because of the increasing volume and uncertain quality of new knowledge, traditional sources of information such as books and journals failed to meet the needs of busy practitioners.Evidence-based medicine promoted strategies for identifying and appraising relevant information and making it readily available. Surgeons face unique challenges in the recognition and application of best evidence. Evidence-based surgery requires careful appraisal of the existing evidence, expanding the pool of level 1 evidence,and improving the availability of best evidence. Ultimately, the organization of systems will incorporate best evidence into the processes of care and will document the outcomes of care.
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Affiliation(s)
- R Scott Jones
- Department of Surgery, University of Virginia Health System, PO Box 800709, Charlottesville, VA 22908-0709, USA.
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Abstract
When physicians and surgeons investigate new drugs or devices, they must adhere to stringent regulatory standards governing human experimentation. Although these standards and regulations are not perfect, they serve to protect the interests of patients and research subjects. By contrast, few standards or regulations exist for innovative procedures, including new surgical techniques. Surgeons apply the term "innovative surgery" to describe practices ranging from minor technical modifications in standard procedures to non-validated investigational approaches indistinguishable from human research. By focusing on recent innovations in surgery, including colorectal surgery, this article proposes an ethical model of surgical innovation that protects patients while maintaining professional self-regulation of surgical advances.
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Affiliation(s)
- Jonathan M Marron
- MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, Illinois 60637-1470, USA
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35
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Strasberg SM, Ludbrook PA. Who oversees innovative practice? Is there a structure that meets the monitoring needs of new techniques? J Am Coll Surg 2003; 196:938-48. [PMID: 12788432 DOI: 10.1016/s1072-7515(03)00112-1] [Citation(s) in RCA: 65] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
Affiliation(s)
- Steven M Strasberg
- Section of Hepato-Pancreato-Biliary Surgery, Department of Surgery, St Louis, MO 63110, USA
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36
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Kanaan SA, Murayama KM, Merriam LT, Dawes LG, Prystowsky JB, Rege RV, Joehl RJ. Risk factors for conversion of laparoscopic to open cholecystectomy. J Surg Res 2002; 106:20-4. [PMID: 12127803 DOI: 10.1006/jsre.2002.6393] [Citation(s) in RCA: 52] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022]
Abstract
BACKGROUND Laparoscopic cholecystectomy (LC) has become the treatment of choice for symptomatic gallstones; however conversion to open cholecystectomy (OC) remains a possibility. Unfortunately, preoperative factors indicating risk of conversion are unclear. Therefore, we aimed to identify risk factors associated with conversion of LC to OC. PATIENTS AND MATERIALS Records of 564 patients undergoing LC in 1995 and 1996 were reviewed. Patients were assigned to one of two groups: (1) acute cholecystitis defined by the presence of gallstones, fever, leukocyte count >10(4), and inflammation on ultrasound or histology; (2) chronic cholecystitis that included all other symptomatic patients. Demographics, history, and physical, laboratory, and radiology data, operative note, and the pathology report were reviewed. RESULTS 161 of 564 patients, had acute and 403 patients had chronic cholecystitis; 16 acute cholecystitis patients (10%) were converted from LC to OC and 17 chronic cholecystitis patients (4%) had LC converted to OC. Patients having open conversion were significantly older, had greater prevalence of cardiovascular disease, and were more likely to be males. LC conversion to OC in acute cholecystitis patients was associated with a greater leukocyte count; in gangrenous cholecystitis patients, 29% had open conversion. CONCLUSIONS Importantly, these risk factors-older men, presence of cardiovascular disease, male gender, acute cholecystitis, and severe inflammation-are determined preoperatively, permitting the surgeon to better inform patients about the conversion risk from LC to OC. While acute cholecystitis was associated with more than a twofold increased conversion rate, only 10% of these patients could not be completed laparoscopically. Therefore, acute cholecystitis alone should not preclude an attempt at laparoscopic cholecystectomy.
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Affiliation(s)
- Samer A Kanaan
- Northwestern University Medical School, Chicago, IL 60611, USA
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Abstract
Bile duct injury is a serious and feared complication of laparoscopic cholecystectomy. Examination of four frequently repeated statements about this problem in the literature, and in the medico-legal expert reports indicate that these statements are not supported by valid data and, therefore, can be termed 'myths'.
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Affiliation(s)
- Thomas B Hugh
- St Vincent's Hospital, Sydney, New South Wales, Australia.
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Coda A, Bossotti M, Ferri F, Mattio R, Ramellini G, Poma A, Quaglino F, Filippa C, Bona A. Surg Laparosc Endosc Percutan Tech 2000; 10:34-38. [DOI: 10.1097/00019509-200002000-00008] [Citation(s) in RCA: 20] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register]
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40
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Abstract
The purpose of this study was to evaluate the impact of hospital credentialing standards on surgical outcomes for selected procedures. The study used hospital credentialing practices from a 1996 survey of North Carolina community hospitals, with surgical outcomes derived from a statewide database of inpatient surgical discharges in 1995. Hospital mortality, complications and elevated lengths of stay were used as outcome indicators in an analysis of 6 surgical procedures. Multivariate logit analysis was used to calculate the effects of hospital credentialing stringency and nine credentialing practices on outcomes, controlling for patient demographic characteristics, type of admission, severity of illness and hospital characteristics. Teaching hospitals adopted more stringent credentialing practices, with almost no difference between metropolitan and nonmetropolitan nonteaching facilities in their use of various credentialing policies. Surgical outcomes typically were not related to stringency of the hospital credentialing environment. Generally, the effect of specific practices was inconsistent (associated with improved outcomes for certain procedures and significantly worse outcomes for others) or counterintuitive (showing worse outcomes for selected surgical procedures where effects were statistically significant). More stringent hospital credentialing does not appear likely to improve patient outcomes.
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Affiliation(s)
- F A Sloan
- Center for Health Policy, Law and Management, Sanford Institute of Public Policy, Duke University, Durham, NC 27708, USA
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Fletcher DR, Hobbs MS, Tan P, Valinsky LJ, Hockey RL, Pikora TJ, Knuiman MW, Sheiner HJ, Edis A. Complications of cholecystectomy: risks of the laparoscopic approach and protective effects of operative cholangiography: a population-based study. Ann Surg 1999; 229:449-57. [PMID: 10203075 PMCID: PMC1191728 DOI: 10.1097/00000658-199904000-00001] [Citation(s) in RCA: 318] [Impact Index Per Article: 12.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
BACKGROUND Previous studies suggest that laparoscopic cholecystectomy (LC) is associated with an increased risk of intraoperative injury involving the bile ducts, bowel, and vascular structures compared with open cholecystectomy (OC). Population-based studies are required to estimate the magnitude of the increased risk, to determine whether this is changing over time, and to identify ways by which this might be reduced. METHODS Suspected cases of intraoperative injury associated with cholecystectomy in Western Australia in the period 1988 to 1994 were identified from routinely collected hospital statistical records and lists of persons undergoing postoperative endoscopic retrograde cholangiopancreatography. The case records of suspect cases were reviewed to confirm the nature and site of injury. Ordinal logistic regression was used to estimate the risk of injury associated with LC compared with OC after adjusting for confounding factors. RESULTS After the introduction of LC in 1991, the proportion of all cholecystectomy cases with intraoperative injury increased from 0.67% in 1988-90 to 1.33% in 1993-94. Similar relative increases were observed in bile duct injuries, major bile leaks, and other injuries to bowel or vascular structures. Increases in intraoperative injury were observed in both LC and OC. After adjustment for age, gender, hospital type, severity of disease, intraoperative cholangiography, and calendar period, the odds ratio for intraoperative injury in LC compared with OC was 1.79. Operative cholangiography significantly reduced the risk of injury. CONCLUSION Operative cholangiography has a protective effect for complications of cholecystectomy. Compared with OC, LC carries a nearly twofold higher risk of major bile, vascular, and bowel complications. Further study is required to determine the extent to which potentially preventable factors contribute to this risk.
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Affiliation(s)
- D R Fletcher
- Department of Surgery, University of Western Australia and Fremantle Hospital, Australia
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Abstract
Treatment of gallstones by laparoscopic cholecystectomy has become standard therapy over the past decade and has received wide patient acceptance. Problems are infrequent but those such as biliary injury may be serious and continue to be a cause of concern. Biliary injury is more likely when surgery is performed in the presence of acute inflammation. Laparoscopic bile duct exploration is becoming standardized and the results are good. The role of other laparoscopic biliary procedures such as biliary bypass is still uncertain.
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Affiliation(s)
- S M Strasberg
- Section of Hepatobiliary-Pancreatic Surgery, Washington University, St. Louis, Missouri, USA
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Sbeih F, Aljohani M, Altraif I, Khan H. Role of endoscopic retrograde cholangiopancreatography before and after laparoscopic cholecystectomy. Ann Saudi Med 1998; 18:117-9. [PMID: 17341940 DOI: 10.5144/0256-4947.1998.117] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
Abstract
BACKGROUND While the role of endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (EST) in the diagnosis and management of choledocholithiasis is well established, this study evaluates the usefulness of ERCP and EST in patients with symptomatic cholecystolithiasis and suspected choledocholithiasis before undergoing laparoscopic cholecystectomy (LC), and the role of ERCP-EST in the management of complications resulting from LC. MATERIALS AND METHODS This paper reviews retrospectively our experience from 1992 to 1995. A total of 1221 LCs and 717 ERCPs were performed, out of which 257 ERCPs were performed on 225 patients who underwent LC (230 ERCPs before and 27 after). The age range was 10-85 years (mean 43.5). The study group comprised 148 females (66%) and 77 males (34%). RESULTS The overall success rate for ERCP was 92% (96% for diagnostic and 88% for therapeutic). Choledocholithiasis was found at preoperative ERCP in 45% of cases. Prediction of choledocholithiasis was accurate in 46%, based on abnormal liver chemistry, and 70% when based on a combination of abnormal liver tests and dilated main bile duct (>7 mm) by ultrasound. In 40 cases of acute biliary pancreatitis, choledocholithiasis was found at ERCP in eight cases (20%). In the post-LC group, all eight cases with residual stones and seven of eight cases with bile leaks were successfully treated endoscopically. There were four cases with major duct injuries that required surgical management. The complications related to ERCP-EST included two cases of bleeding post-EST (one was controlled with injection therapy and the second one was managed surgically), and three cases of mild pancreatitis. CONCLUSION ERCP and EST are effective and safe in the diagnosis and management of choledocholithiasis, and facilitate LC for symptomatic cholelithiasis. The procedures are also valuable in the diagnosis and management of most complications resulting from LC.
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Affiliation(s)
- F Sbeih
- Department of Medicine, Section of Gastroenterology, King Fahad National Guard Hospital, Riyadh, Saudi Arabia
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Johnson AG. New interventional procedures: efficacy, safety and training. THE AUSTRALIAN AND NEW ZEALAND JOURNAL OF SURGERY 1998; 68:3-5. [PMID: 9440446 DOI: 10.1111/j.1445-2197.1998.tb04626.x] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Affiliation(s)
- A G Johnson
- Department of Surgical and Anaesthetic Sciences, Royal Hallamshire Hospital, Sheffield, United Kingdom
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Abstract
Although much is still to be learned about the pathogenesis of cholelithiasis, recent investigations have greatly advanced our knowledge regarding the mechanisms of cholesterol supersaturation and nucleation. Laparoscopic cholecystectomy has lessened the usual peri-operative morbidity of cholecystectomy, but is associated with a higher bile duct injury rate. Acute cholecystitis, the commonest complication of cholelithiasis, is a chemical inflammation usually requiring cystic duct obstruction and supersaturated bile. The treatment of this condition in the laparoscopic era is controversial. Early operation may lessen hospital stay but an increased risk of biliary injury has been reported.
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Affiliation(s)
- S M Strasberg
- Department of Surgery, Washington University, St Louis, Missouri, USA
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Lillemoe KD, Martin SA, Cameron JL, Yeo CJ, Talamini MA, Kaushal S, Coleman J, Venbrux AC, Savader SJ, Osterman FA, Pitt HA. Major bile duct injuries during laparoscopic cholecystectomy. Follow-up after combined surgical and radiologic management. Ann Surg 1997; 225:459-68; discussion 468-71. [PMID: 9193174 PMCID: PMC1190777 DOI: 10.1097/00000658-199705000-00003] [Citation(s) in RCA: 153] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
OBJECTIVE The authors provide the results of follow-up evaluation after combined surgical and radiologic management of 89 patients with major bile duct injuries during laparoscopic cholecystectomy. SUMMARY BACKGROUND DATA The incidence and mechanism of injury of major bile duct injuries during laparoscopic cholecystectomy has been clearly defined. Furthermore, a number of series have described the management of these injuries by surgical, endoscopic, and radiologic techniques with excellent short-term results. Long-term follow-up data, however, are lacking in the management of these injuries. METHODS Data were collected prospectively on 89 patients treated at a single institution with major bile duct injuries after laparoscopic cholecystectomy managed between July 1, 1990, and July 1, 1996. Patients referred with injuries underwent early percutaneous transhepatic cholangiography and biliary drainage. Based on the cholangiographic appearance and clinical situation, patients were managed by either percutaneous balloon dilatation or surgical reconstruction with a Roux-en-Y hepaticojejunostomy with transanastomotic stenting. Follow-up was obtained by personal interview during October 1996. RESULTS Two patients died without an attempt at definitive therapy. Both deaths were caused by sepsis and multisystem organ failure present at the time of transfer to the authors' institution. The remaining 87 patients were managed initially by either balloon dilatation (N = 28) or surgical reconstruction (N = 59). Ten patients have not completed treatment and still have biliary stents in place. Evaluation of 25 patients completing treatment after balloon dilatation (mean follow-up, 27.8 months) showed a success rate of 64%. Evaluation of 52 patients completing treatment after surgical reconstruction (mean follow-up, 33.4 months) showed a success rate of 92%. All failures were managed successfully by either surgical reconstruction or balloon dilatation. CONCLUSIONS Major bile duct injuries can be managed successfully by combined surgical and radiologic techniques. This series provides, for the first time, significant follow-up on a large number of patients with overall success rates of 64% after balloon dilatation and 92% after surgical reconstruction. The combination of surgery and balloon dilatation resulted in a successful outcome in 100% of patients treated.
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Affiliation(s)
- K D Lillemoe
- Department of Surgery, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
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Affiliation(s)
- A Johnson
- Department of Surgical and Anaesthetic Sciences, University of Sheffield, Royal Hallamshire Hospital, UK
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Affiliation(s)
- J J Escarce
- Division of General Internal Medicine, School of Medicine, University of Pennsylvania, Philadelphia, USA
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