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Kwon SH, Joo YI, Kim SH, Lee DH, Baek JH, Chung SS, Shin JY, Eun CS, Kim NK. Meta-analysis of transanal versus laparoscopic total mesorectal excision for rectal cancer: a 'New Health Technology' assessment in South Korea. Ann Surg Treat Res 2021; 101:167-180. [PMID: 34549040 PMCID: PMC8424436 DOI: 10.4174/astr.2021.101.3.167] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/10/2021] [Revised: 06/11/2021] [Accepted: 07/13/2021] [Indexed: 12/30/2022] Open
Abstract
Purpose Under the South Korea's unique health insurance structure, any new surgical technology must be evaluated first by the government in order to consider whether that particular technology can be applied to patients for further clinical trials as categorized as 'New Health Technology,' then potentially covered by the insurance sometime later. The aim of this meta-analysis was to assess the safety and efficacy of transanal total mesorectal excision (TaTME) for rectal cancer, activated by the National Evidence-based Healthcare Collaborating Agency (NECA) TaTME committee. Methods We systematically searched Ovid-MEDLINE, Ovid-Embase, Cochrane, and Korean databases (from their inception until August 31, 2019) for studies published that compare TaTME with laparoscopic total mesorectal excision (LaTME). End-points included perioperative and pathological outcomes. Results Sixteen cohort studies (7 for case-matched studies) were identified, comprising 1,923 patients (938 TaTMEs and 985 LaTMEs). Regarding perioperative outcomes, the conversion rate was significantly lower in TaTME (risk ratio, 0.19; 95% confidence interval, 0.11-0.34; P < 0.001); whereas other perioperative outcomes were similar to LaTME. There were no statistically significant differences in pathological results between the 2 procedures. Conclusion Our meta-analysis showed comparable results in preoperative and pathologic outcomes between TaTME and LaTME, and indicated the benefit of TaTME with low conversion. Extensive evaluations of well-designed, multicenter randomized controlled trials are required to come to unequivocal conclusions, but the results showed that TaTME is a potentially beneficial technique in some specific cases. This meta-analysis suggests that TaTME can be performed for rectal cancer patients as a 'New Health Technology' endorsed by NECA in South Korea.
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Affiliation(s)
- Sun-Ho Kwon
- Division for New Health Technology Assessment, National Evidence-based Healthcare Collaborating Agency, Seoul, Korea
| | - Yea-Il Joo
- Division for New Health Technology Assessment, National Evidence-based Healthcare Collaborating Agency, Seoul, Korea
| | - Seon Hahn Kim
- TaTME Assessment Committee, National Evidence-based Healthcare Collaborating Agency, Seoul, Korea.,Division of Colorectal Surgery, Department of Surgery, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea
| | - Dae Ho Lee
- TaTME Assessment Committee, National Evidence-based Healthcare Collaborating Agency, Seoul, Korea.,Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Jeong-Heum Baek
- TaTME Assessment Committee, National Evidence-based Healthcare Collaborating Agency, Seoul, Korea.,Division of Colon and Rectal Surgery, Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea
| | - Soon Sup Chung
- TaTME Assessment Committee, National Evidence-based Healthcare Collaborating Agency, Seoul, Korea.,Department of General Surgery, Ewha Womans University College of Medicine, Seoul, Korea
| | - Ji-Yeon Shin
- TaTME Assessment Committee, National Evidence-based Healthcare Collaborating Agency, Seoul, Korea.,Department of Preventive Medicine, School of Medicine, Kyungpook National University, Daegu, Korea
| | - Chang Soo Eun
- TaTME Assessment Committee, National Evidence-based Healthcare Collaborating Agency, Seoul, Korea.,Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea
| | - Nam Kyu Kim
- TaTME Assessment Committee, National Evidence-based Healthcare Collaborating Agency, Seoul, Korea.,Department of Surgery, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea
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Rega D, Granata V, Petrillo A, Pace U, Sassaroli C, Di Marzo M, Cervone C, Fusco R, D’Alessio V, Nasti G, Romano C, Avallone A, Pecori B, Botti G, Tatangelo F, Maiolino P, Delrio P. Organ Sparing for Locally Advanced Rectal Cancer after Neoadjuvant Treatment Followed by Electrochemotherapy. Cancers (Basel) 2021; 13:cancers13133199. [PMID: 34206858 PMCID: PMC8267997 DOI: 10.3390/cancers13133199] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2021] [Revised: 06/23/2021] [Accepted: 06/23/2021] [Indexed: 12/21/2022] Open
Abstract
Simple Summary This is a Phase II randomized controlled trial conducted with the aim of investigating whether the use of Electrochemotherapy after neoadjuvant therapy (ECT) and before surgery in patients with major clinical response allows for a more conservative surgical approach in patients with Locally Advanced Rectal Cancer (LARC) in comparison with the control group that will not receive ECT. The treatment response, in both the control arm and in the treatment arm, will be assessed using the histopathological tumor regression grade on tissue specimens after local excision. Abstract Background: Currently, 45–55% of rectal cancer patients receive preoperative chemo- radio-therapy for Locally Advanced Rectal Cancer (LARC). The idea of our study is to use Electrochemotherapy (ECT) before surgery, in patients with major clinical response after neoadjuvant therapy, to allow for a more conservative surgical approach. Objective: To evaluate the increase of the complete response rate after neoadjuvant treatment in LARC and to spare organ function due to total mesorectal excision (TME). Patients and Methods: This is a Phase II randomized controlled trial enrolling 70 patients that will be developed in two stages. In the first step, 28 patients will be enrolled: 14 of these will receive ECT for four weeks after neo-adjuvant treatment and then local excision (treatment group) and 14 patients will receive neo-adjuvant treatment and then local excision (control group). If an increase of response rate is observed in the first stage, and/or feasibility/safety is demonstrated, the second stage of the trial will be performed, enrolling an additional 42 patients. The treatment response. in both the control arm and the treatment arm, will be assessed using the histopathological tumor regression grade on tissue specimens after local excision.
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Affiliation(s)
- Daniela Rega
- Division of Colorectal Surgery, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy; (D.R.); (U.P.); (C.S.); (M.D.M.); (C.C.); (P.D.)
| | - Vincenza Granata
- Division of Radiology, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy;
- Correspondence:
| | - Antonella Petrillo
- Division of Radiology, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy;
| | - Ugo Pace
- Division of Colorectal Surgery, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy; (D.R.); (U.P.); (C.S.); (M.D.M.); (C.C.); (P.D.)
| | - Cinzia Sassaroli
- Division of Colorectal Surgery, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy; (D.R.); (U.P.); (C.S.); (M.D.M.); (C.C.); (P.D.)
| | - Massimiliano Di Marzo
- Division of Colorectal Surgery, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy; (D.R.); (U.P.); (C.S.); (M.D.M.); (C.C.); (P.D.)
| | - Carmela Cervone
- Division of Colorectal Surgery, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy; (D.R.); (U.P.); (C.S.); (M.D.M.); (C.C.); (P.D.)
| | - Roberta Fusco
- IGEA SpA Medical Division-Oncology, Via Casarea 65, Casalnuovo di Napoli, I-80013 Napoli, Italy; (R.F.); (V.D.)
| | - Valeria D’Alessio
- IGEA SpA Medical Division-Oncology, Via Casarea 65, Casalnuovo di Napoli, I-80013 Napoli, Italy; (R.F.); (V.D.)
| | - Guglielmo Nasti
- Division of Abdominal Medical Oncology, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy; (G.N.); (C.R.); (A.A.)
| | - Carmela Romano
- Division of Abdominal Medical Oncology, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy; (G.N.); (C.R.); (A.A.)
| | - Antonio Avallone
- Division of Abdominal Medical Oncology, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy; (G.N.); (C.R.); (A.A.)
| | - Biagio Pecori
- Division of Abdominal Radiotherapy, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy;
| | - Gerardo Botti
- Division of Pathological Anatomy, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy; (G.B.); (F.T.)
| | - Fabiana Tatangelo
- Division of Pathological Anatomy, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy; (G.B.); (F.T.)
| | - Piera Maiolino
- Division of Pharmacy, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy;
| | - Paolo Delrio
- Division of Colorectal Surgery, Istituto Nazionale Tumori IRCCS Fondazione Pascale—IRCCS di Napoli, I-80131 Naples, Italy; (D.R.); (U.P.); (C.S.); (M.D.M.); (C.C.); (P.D.)
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Vignali A, Elmore U, Milone M, Rosati R. Transanal total mesorectal excision (TaTME): current status and future perspectives. Updates Surg 2019; 71:29-37. [PMID: 30734896 DOI: 10.1007/s13304-019-00630-7] [Citation(s) in RCA: 29] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/10/2018] [Accepted: 02/02/2019] [Indexed: 12/14/2022]
Abstract
Total mesorectal excision (TME) is the gold standard surgical treatment for mid- and low rectal cancer; however, it is associated with specific technical hurdles. Transanal TME (TaTME) is a new procedure developed to overcome these difficulties, through an enhanced visualization of the dissection plane. This potentially could result in a more accurate distal dissection with a lower rate of positive circumferential resection margins, increasing the rate of sphincter-saving procedures. The indications for TaTME are currently expanding, despite not being yet standardized, and structured training programs are ongoing to help overcome the steep learning curve related to the technique. The procedure is feasible and safe with similar intraoperative complications and readmission rates when compared with conventional open or laparoscopic TME. Favorable short-term oncologic results have been reported: in particular, TaTME is associated with mesorectal specimen of a better quality and a longer distal resection margin that is established at the beginning of the procedure under direct view. Robotics, when available, will probably overcome the steep learning curve related to the complexity of TaTME. Long-term follow-up and ongoing RCT trials data are awaited regarding functional results, local recurrence and survival, and to facilitate the comparison with standard laparoscopic or robotic rectal resections. The present review is focused on critically analyzing the theoretical benefits and risks of the procedure, its indications, short- and long-term results and future direction in the application of TaTME.
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Affiliation(s)
- Andrea Vignali
- Department of Surgery, San Raffaele Hospital and San Raffaele Vita-Salute University, Via Olgettina 60, 20123, Milan, Italy.
| | - Ugo Elmore
- Department of Surgery, San Raffaele Hospital and San Raffaele Vita-Salute University, Via Olgettina 60, 20123, Milan, Italy
| | - Marco Milone
- Department of Surgical Specialties, Nephrology University "Federico II" of Naples, Naples, Italy
| | - Riccardo Rosati
- Department of Surgery, San Raffaele Hospital and San Raffaele Vita-Salute University, Via Olgettina 60, 20123, Milan, Italy
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Roodbeen SX, Penna M, Mackenzie H, Kusters M, Slater A, Jones OM, Lindsey I, Guy RJ, Cunningham C, Hompes R. Transanal total mesorectal excision (TaTME) versus laparoscopic TME for MRI-defined low rectal cancer: a propensity score-matched analysis of oncological outcomes. Surg Endosc 2018; 33:2459-2467. [PMID: 30350103 PMCID: PMC6647375 DOI: 10.1007/s00464-018-6530-4] [Citation(s) in RCA: 52] [Impact Index Per Article: 7.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/18/2018] [Accepted: 10/11/2018] [Indexed: 12/15/2022]
Abstract
BACKGROUND While a shift to minimally invasive techniques in rectal cancer surgery has occurred, non-inferiority of laparoscopy in terms of oncological outcomes has not been definitely demonstrated. Transanal total mesorectal excision (TaTME) has been pioneered to potentially overcome difficulties experienced when operating with a pure abdominal approach deep down in the pelvis. This study aimed to compare short-term oncological results of TaTME versus laparoscopic TME (lapTME), based on a strict anatomical definition for low rectal cancer on MRI. METHODS From June 2013, all consecutive TaTME cases were included and compared to lapTME in a single institution. Propensity score-matching was performed for nine relevant factors. Primary outcome was resection margin involvement (R1), secondary outcomes included intra- and post-operative outcomes. RESULTS After matching, forty-one patients were included in each group; no significant differences were observed in patient and tumor characteristics. The resection margin was involved in 5 cases (12.2%) in the laparoscopic group, versus 2 (4.9%) TaTME cases (P = 0.432). The TME specimen quality was complete in 84.0% of the laparoscopic cases and in 92.7% of the TaTME cases (P = 0.266). Median distance to the circumferential resection margin (CRM) was 5 mm in lapTME and 10 mm in TaTME (P = 0.065). Significantly more conversions took place in the laparoscopic group, 9 (22.0%) compared to none in the TaTME group (P < 0.001). Other clinical outcomes did not show any significant differences between the two groups. CONCLUSION This is the first study to compare results of TaTME with lapTME in a highly selected patient group with MRI-defined low rectal tumors. A significant decrease in R1 rate could not be demonstrated, although conversion rate was significantly lower in this TaTME cohort.
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Affiliation(s)
- Sapho Xenia Roodbeen
- Department Surgery, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands
| | - Marta Penna
- Department of Colorectal Surgery, Churchill Hospital, Oxford University Hospital NHS Foundation Trust, Oxford, UK
| | - Hugh Mackenzie
- Department of Surgery and Cancer, Imperial College London, London, UK
| | - Miranda Kusters
- Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands
| | - Andrew Slater
- Department of Radiology, Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
| | - Oliver M Jones
- Department of Colorectal Surgery, Churchill Hospital, Oxford University Hospital NHS Foundation Trust, Oxford, UK
| | - Ian Lindsey
- Department of Colorectal Surgery, Churchill Hospital, Oxford University Hospital NHS Foundation Trust, Oxford, UK
| | - Richard J Guy
- Department of Colorectal Surgery, Churchill Hospital, Oxford University Hospital NHS Foundation Trust, Oxford, UK
| | - Chris Cunningham
- Department of Colorectal Surgery, Churchill Hospital, Oxford University Hospital NHS Foundation Trust, Oxford, UK
| | - Roel Hompes
- Department Surgery, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
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Rowen RK, Kelly J, Motl J, Monson JR. Transanal transabdominal TME: how far can we push it? MINERVA CHIR 2018; 73:579-591. [PMID: 30019878 DOI: 10.23736/s0026-4733.18.07827-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
Over many decades, advances in surgical technology, such as the use of the electrocautery Bovie, development of minimally invasive and advanced endoscopic platforms and the ability to create and maintain pneumorectum have propelled surgical techniques forward to today, with development of the transanal total mesorectal excision TME (taTME) for en bloc resection of rectal cancers. The transanal platform offers, for now, a viable alternative to perform safe and oncologically sound TME, especially favorable in cases of low rectal lesions in a narrow pelvis post neoadjuvant treatment. The aspiration of the colorectal community remains to continue to push the operative boundaries whilst maintaining safe oncological principals with the best possible functional outcomes for patients. In this article we review this evolving technique and focus on future directions.
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Affiliation(s)
| | - Justin Kelly
- Surgical Health Outcomes Consortium, Orlando, FL, USA
| | - Jill Motl
- Surgical Health Outcomes Consortium, Orlando, FL, USA
| | - John R Monson
- Surgical Health Outcomes Consortium, Orlando, FL, USA -
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Emile SH, de Lacy FB, Keller DS, Martin-Perez B, Alrawi S, Lacy AM, Chand M. Evolution of transanal total mesorectal excision for rectal cancer: From top to bottom. World J Gastrointest Surg 2018; 10:28-39. [PMID: 29588809 PMCID: PMC5867456 DOI: 10.4240/wjgs.v10.i3.28] [Citation(s) in RCA: 40] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/21/2017] [Revised: 01/07/2018] [Accepted: 02/09/2018] [Indexed: 02/06/2023] Open
Abstract
The gold standard for curative treatment of locally advanced rectal cancer involves radical resection with a total mesorectal excision (TME). TME is the most effective treatment strategy to reduce local recurrence and improve survival outcomes regardless of the surgical platform used. However, there are associated morbidities, functional consequences, and quality of life (QoL) issues associated with TME; these risks must be considered during the modern-day multidisciplinary treatment for rectal cancer. This has led to the development of new surgical techniques to improve patient, oncologic, and QoL outcomes. In this work, we review the evolution of TME to the transanal total mesorectal excision (TaTME) through more traditional minimally invasive platforms. The review the development, safety and feasibility, proposed benefits and risks of the procedure, implementation and education models, and future direction for research and implementation of the TaTME in colorectal surgery. While satisfactory short-term results have been reported, the procedure is in its infancy, and long term outcomes and definitive results from controlled trials are pending. As evidence for safety and feasibility accumulates, structured training programs to standardize teaching, training, and safe expansion will aid the safe spread of the TaTME.
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Affiliation(s)
- Sameh Hany Emile
- Department of General Surgery, Mansoura Faculty of Medicine, Mansoura City 35516, Egypt
| | - F Borja de Lacy
- Department of Surgery, Hospital Clinic, University of Barcelona, Barcelona 08036, Spain
| | - Deborah Susan Keller
- GENIE Centre, University College London, London NW1 2BU, United Kingdom
- Department of Surgery and Interventional Sciences, University College London Hospitals, NHS Trusts, London NW1 2BU, United Kingdom
| | - Beatriz Martin-Perez
- Department of Surgery, Hospital Clinic, University of Barcelona, Barcelona 08036, Spain
| | - Sadir Alrawi
- Department of Surgical Oncology, Alzahra Cancer Center, Al Zahra Hospital, Dubai 3499, United Arab Emirates
| | - Antonio M Lacy
- Department of Surgery, Hospital Clinic, University of Barcelona, Barcelona 08036, Spain
| | - Manish Chand
- GENIE Centre, University College London, London NW1 2BU, United Kingdom
- Department of Surgery and Interventional Sciences, University College London Hospitals, NHS Trusts, London NW1 2BU, United Kingdom
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