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He Y, Liu Q, Chen YW, Cui LJ, Cao K, Guo ZH. Bowel preparation protocol for hospitalized patients ages 50 years or older: A randomized controlled trial. World J Gastrointest Endosc 2024; 16:18-28. [PMID: 38313462 PMCID: PMC10835475 DOI: 10.4253/wjge.v16.i1.18] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/26/2023] [Revised: 12/02/2023] [Accepted: 12/14/2023] [Indexed: 01/15/2024] Open
Abstract
BACKGROUND The incidence and mortality rate of colorectal cancer progressively increase with age and become particularly prominent after the age of 50 years. Therefore, the population that is ≥ 50 years in age requires long-term and regular colonoscopies. Uncomfortable bowel preparation is the main reason preventing patients from undergoing regular colonoscopies. The standard bowel preparation regimen of 4-L polyethylene glycol (PEG) is effective but poorly tolerated. AIM To investigate an effective and comfortable bowel preparation regimen for hospitalized patients ≥ 50 years in age. METHODS Patients were randomly assigned to group 1 (2-L PEG + 30-mL lactulose + a low-residue diet) or group 2 (4-L PEG). Adequate bowel preparation was defined as a Boston bowel preparation scale (BBPS) score of ≥ 6, with a score of ≥ 2 for each segment. Non-inferiority was prespecified with a margin of 10%. Additionally, the degree of comfort was assessed based on the comfort questionnaire. RESULTS The proportion of patients with a BBPS score of ≥ 6 in group 1 was not significantly different from that in group 2, as demonstrated by intention-to-treat (91.2% vs 91.0%, P = 0.953) and per-protocol (91.8% vs 91.0%, P = 0.802) analyses. Furthermore, in patients ≥ 75 years in age, the proportion of BBPS scores of ≥ 6 in group 1 was not significantly different from that in group 2 (90.9% vs 97.0%, P = 0.716). Group 1 had higher comfort scores (8.85 ± 1.162 vs 7.59 ± 1.735, P < 0.001), longer sleep duration (6.86 ± 1.204 h vs 5.80 ± 1.730 h, P < 0.001), and fewer awakenings (1.42 ± 1.183 vs 2.04 ± 1.835, P = 0.026) than group 2. CONCLUSION For hospitalized patients ≥ 50 years in age, the bowel preparation regimen comprising 2-L PEG + 30-mL lactulose + a low-residue diet produced a cleanse that was as effective as the 4-L PEG regimen and even provided better comfort.
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Affiliation(s)
- Yu He
- Department of Geriatrics, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
| | - Qi Liu
- Department of Geriatrics, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
| | - Yi-Wen Chen
- Department of Geriatrics, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
| | - Li-Jian Cui
- Department of Gastroenterology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
| | - Kai Cao
- Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
| | - Zi-Hao Guo
- Department of Gastroenterology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
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Shahini E, Sinagra E, Vitello A, Ranaldo R, Contaldo A, Facciorusso A, Maida M. Factors affecting the quality of bowel preparation for colonoscopy in hard-to-prepare patients: Evidence from the literature. World J Gastroenterol 2023; 29:1685-1707. [PMID: 37077514 PMCID: PMC10107216 DOI: 10.3748/wjg.v29.i11.1685] [Citation(s) in RCA: 34] [Impact Index Per Article: 17.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/01/2022] [Revised: 02/02/2023] [Accepted: 03/07/2023] [Indexed: 03/17/2023] Open
Abstract
Adequate bowel cleansing is critical for a high-quality colonoscopy because it affects diagnostic accuracy and adenoma detection. Nevertheless, almost a quarter of procedures are still carried out with suboptimal preparation, resulting in longer procedure times, higher risk of complications, and higher likelihood of missing lesions. Current guidelines recommend high-volume or low-volume polyethylene glycol (PEG)/non-PEG-based split-dose regimens. In patients who have had insufficient bowel cleansing, the colonoscopy should be repeated the same day or the next day with additional bowel cleansing as a salvage option. A strategy that includes a prolonged low-fiber diet, a split preparation regimen, and a colonoscopy within 5 h of the end of preparation may increase cleansing success rates in the elderly. Furthermore, even though no specific product is specifically recommended in the other cases for difficult-to-prepare patients, clinical evidence suggests that 1-L PEG plus ascorbic acid preparation are associated with higher cleansing success in hospitalized and inflammatory bowel disease patients. Patients with severe renal insufficiency (creatinine clearance < 30 mL/min) should be prepared with isotonic high volume PEG solutions. Few data on cirrhotic patients are currently available, and no trials have been conducted in this population. An accurate characterization of procedural and patient variables may lead to a more personalized approach to bowel preparation, especially in patients undergoing resection of left colon lesions, where intestinal preparation has a poor outcome. The purpose of this review was to summarize the evidence on the risk factors influencing the quality of bowel cleansing in difficult-to-prepare patients, as well as strategies to improve colonoscopy preparation in these patients.
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Affiliation(s)
- Endrit Shahini
- Gastroenterology Unit, National Institute of Gastroenterology-IRCCS “Saverio de Bellis”, Castellana Grotte, Bari 70013, Italy
| | - Emanuele Sinagra
- Gastroenterology and Endoscopy Unit, Fondazione Istituto G. Giglio, Cefalù 90015, Italy
| | - Alessandro Vitello
- Gastroenterology and Endoscopy Unit, S.Elia-Raimondi Hospital, Caltanissetta 93100, Italy
| | - Rocco Ranaldo
- Department of Internal Medicine, “Mazzolani-Vandini” Hospital, Digestive Endoscopy, Ferrara 744011, Italy
| | - Antonella Contaldo
- Gastroenterology Unit, National Institute of Gastroenterology “S de Bellis” Research Hospital, Bari 70013, Italy
| | - Antonio Facciorusso
- Department of Medical Sciences, University of Foggia, Section of Gastroenterology, Foggia 71122, Italy
| | - Marcello Maida
- Gastroenterology and Endoscopy Unit, S.Elia-Raimondi Hospital, Caltanissetta 93100, Italy
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The Efficacy of Senna Bowel Preparation for Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterol Nurs 2022; 45:428-439. [PMID: 35758925 DOI: 10.1097/sga.0000000000000664] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/29/2021] [Accepted: 02/17/2022] [Indexed: 11/26/2022] Open
Abstract
The quality of bowel preparation is an extremely important determinant of colonoscopy results. However, the efficacy of senna regimens in improving bowel cleanliness is uncertain. We conducted a systematic review and meta-analysis to synthesize data on whether using a senna bowel preparation regimen enhances the bowel cleanliness. We searched Web of Science Core Collection, MEDLINE, PubMed, Embase, Cochrane Library, and Scopus databases (from the inception to August 2021). The primary efficacy outcome was bowel cleanliness. Secondary outcomes included patient compliance, tolerance, and adverse events. Eleven trials fulfilled the inclusion criteria (3,343 patients. Overall, we found no significant differences in bowel cleanliness between the senna regimen and other bowel preparation regimens (odds ratio [95% confidence interval]: 1.02 [0.63, 1.67], p = 0.93). There was significant difference in tolerance (odds ratio [95% confidence interval]: 1.66 [1.08, 2.54], p = .02) and compliance (odds ratio [95% confidence interval]: 3.05 [1.42, 6.55], p = .004). The senna regimen yielded a significantly greater proportion of no nausea (odds ratio [95% confidence interval]: 1.84 [1.45, 2.32]) and vomiting (odds ratio [95% confidence interval]: 1.65 [0.81, 3.35]). Compared with other bowel preparation regimens, the senna regimen may be effective and safe in bowel cleaning before colonoscopy, with superior compliance and tolerance.
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Di Leo M, Iannone A, Arena M, Losurdo G, Palamara MA, Iabichino G, Consolo P, Rendina M, Luigiano C, Di Leo A. Novel frontiers of agents for bowel cleansing for colonoscopy. World J Gastroenterol 2021; 27:7748-7770. [PMID: 34963739 PMCID: PMC8661374 DOI: 10.3748/wjg.v27.i45.7748] [Citation(s) in RCA: 17] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/17/2021] [Revised: 04/23/2021] [Accepted: 11/24/2021] [Indexed: 02/06/2023] Open
Abstract
The incidence of colorectal cancer (CRC) is characterized by rapid declines in the wake of widespread screening. Colonoscopy is the gold standard for CRC screening, but its accuracy is related to high quality of bowel preparation (BP). In this review, we aimed to summarized the current strategy to increase bowel cleansing before colonoscopy. Newly bowel cleansing agents were developed with the same efficacy of previous agent but requiring less amount of liquid to improve patients' acceptability. The role of the diet before colonoscopy was also changed, as well the contribution of educational intervention and the use of adjunctive drugs to improve patients' tolerance and/or quality of BP. The review also described BP in special situations, as lower gastrointestinal bleeding, elderly people, patients with chronic kidney disease, patients with inflammatory bowel disease, patients with congestive heart failure, inpatient, patient with previous bowel resection, pregnant/lactating patients. The review underlined the quality of BP should be described using a validate scale in colonoscopy report and it explored the available scales. Finally, the review explored the possible contribution of bowel cleansing in post-colonoscopy syndrome that can be related by a transient alteration of gut microbiota. Moreover, the study underlined several points needed to further investigations.
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Affiliation(s)
- Milena Di Leo
- Unit of Digestive Endoscopy, San Paolo Hospital, Milan 20090, Italy
| | - Andrea Iannone
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari 70124, Italy
| | - Monica Arena
- Unit of Digestive Endoscopy, San Paolo Hospital, Milan 20090, Italy
| | - Giuseppe Losurdo
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari 70124, Italy
| | | | | | - Pierluigi Consolo
- Unit of Digestive Endoscopy, University of Messina, Hospital "G. Martino", Messina 98121, Italy
| | - Maria Rendina
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari 70124, Italy
| | - Carmelo Luigiano
- Unit of Digestive Endoscopy, San Paolo Hospital, Milan 20090, Italy
| | - Alfredo Di Leo
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari 70124, Italy
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A Randomized, Endoscopist-Blinded, Prospective Trial to Compare the Efficacy and Patient Tolerability between Bowel Preparation Protocols Using Sodium Picosulfate Magnesium Citrate and Polyethylene-Glycol (1 L and 2 L) for Colonoscopy. Gastroenterol Res Pract 2020; 2020:9548171. [PMID: 32190045 PMCID: PMC7072100 DOI: 10.1155/2020/9548171] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/30/2019] [Revised: 01/12/2020] [Accepted: 02/14/2020] [Indexed: 12/18/2022] Open
Abstract
Patient compliance during bowel preparation is important for successful colonoscopy. Bowel preparation with polyethylene glycol (PEG), the most commonly used solution for cleansing, involves the unpleasant ingestion of a large amount of liquid. Sodium picosulfate magnesium citrate (SP-MC) solution is an alternative option with better palatability than PEG. Therefore, in this study, we compared the efficacy and patient tolerability among the following three bowel preparation protocols: 2 L PEG-ascorbic acid (ASc), 1 L PEG-ASc plus bisacodyl, and SP-MC 340 mL plus bisacodyl. We conducted a randomized prospective endoscopist-blinded study between August 2018 and January 2019. A total of 311 patients were randomly classified into three groups according to the above-described bowel preparation protocols. To evaluate the efficacy of bowel cleansing, we used the Boston Bowel Preparation Scale. The degree of symptoms and the patients' satisfaction with each bowel preparation method were investigated using a questionnaire completed before sedation for colonoscopy. The baseline characteristics were similar among the three groups. There was no significant difference in the bowel preparation quality among the three groups. However, the incidence of symptoms, such as abdominal fullness and pain, was significantly lower (P = 0.006 and 0.027, respectively) while the patients' satisfaction rate was significantly higher (P = 0.012) in the SP-MC plus bisacodyl group than in the two PEG groups. In this study, the efficacy of the SP-MC plus bisacodyl solution was similar to that of the PEG solutions. However, patient tolerability and satisfaction were better in the SP-MC plus bisacodyl group than in the other groups. In conclusion, the use of SP-MC plus bisacodyl bowel preparation solution might be a better method for providing good intestinal cleansing and improving patient compliance.
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Risk of Renal Injury After the Use of Polyethylene Glycol for Outpatient Colonoscopy: A Prospective Observational Study. J Clin Gastroenterol 2019; 53:e444-e450. [PMID: 30358643 DOI: 10.1097/mcg.0000000000001140] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
GOAL The goal of this study was to estimate the risk of renal injury after the use of 3-L polyethylene glycol (PEG) before outpatient colonoscopy. BACKGROUND Population-based studies showed that the use of PEG was associated with renal injury, but this association has not been confirmed by prospective study. STUDY Patients ≥40 years of age with an estimated glomerular filtration rate ≥30 mL/min were screened for enrollment. Laboratory data were collected before, during, and after the colonoscopies. Patients with a ≥30% increase in baseline serum creatinine levels were followed until a peak level was detected. Renal injury included acute renal dysfunction (ARD) and acute kidney injury (AKI), defined as a 30% to 49% increase and ≥50% increase in creatinine levels compared with the baseline, respectively. RESULTS A total of 1163 patients (mean age, 55.7 y) completed the study. Baseline and first postcolonoscopy laboratory data were obtained an average of 17.0 days before and 17.3 days after the colonoscopies were performed, respectively. Renal injury was identified in 32 patients; 26 patients (2.2%) had ARD, and 6 patients (0.5%) had AKI. All patients with renal injury recovered fully during follow-up. In the subgroup analysis, the use of nonsteroidal anti-inflammatory drugs (NSAIDs) before colonoscopy was statistically associated with the development of AKI (odds ratio, 6.5; 95% confidence interval, 1.2-35.5; P=0.03). CONCLUSIONS This prospective study showed that the use of PEG was associated with a small risk of renal injury. NSAIDs use was statistically associated with AKI in the context of colonoscopy for which PEG was used for bowel preparation.
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Davies MRP, Williams D, Niewiadomski OD. Phosphate nephropathy: an avoidable complication of bowel preparation for colonoscopy. Intern Med J 2018; 48:1141-1144. [PMID: 30182391 DOI: 10.1111/imj.14015] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/01/2017] [Revised: 02/22/2018] [Accepted: 03/01/2018] [Indexed: 01/21/2023]
Abstract
It is known that oral sodium phosphate, used as bowel preparation for colonoscopy, can cause acute phosphate nephropathy, a potentially severe and irreversible form of acute kidney injury. Due to these safety concerns, guidelines have advised against the routine use of this agent for a decade. We present a case report and biopsy series that demonstrate that oral sodium phosphate is still being used and that cases of APN are still occurring, in Australia.
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Affiliation(s)
| | - David Williams
- Department of Anatomical Pathology, Austin Hospital, Melbourne, Victoria, Australia
| | - Olga D Niewiadomski
- Department of Gastroenterology, Eastern Heath, Melbourne, Victoria, Australia
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Lee JM, Keum B, Yoo IK, Kim SH, Choi HS, Kim ES, Seo YS, Jeen YT, Chun HJ, Lee HS, Um SH, Kim CD, Kim MG, Jo SK. Polyethylene glycol plus ascorbic acid for bowel preparation in chronic kidney disease. Medicine (Baltimore) 2016; 95:e4755. [PMID: 27603372 PMCID: PMC5023895 DOI: 10.1097/md.0000000000004755] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open
Abstract
The safety of polyethylene glycol plus ascorbic acid has not been fully investigated in patients with renal insufficiency. High-dose ascorbic acid could induce hyperoxaluria, thereby causing tubule-interstitial nephritis and renal failure. This study aims to evaluate the safety and efficacy of polyethylene glycol plus ascorbic acid in patients with chronic kidney disease.We retrospectively reviewed prospectively collected data on colonoscopy in patients with impaired renal function. Patients were divided into 2 groups: 2 L polyethylene glycol plus ascorbic acid (n = 61) and 4 L polyethylene glycol (n = 80). The safety of the 2 groups was compared by assessing the differences in laboratory findings before and after bowel cleansing.The laboratory findings were not significantly different before and after the administration of 2 L polyethylene glycol plus ascorbic acid or 4 L polyethylene glycol. In both groups, the estimated glomerular filtration rate was not influenced by the administration of the bowel-cleansing agent. Patients' reports on tolerance and acceptability were better in the 2 L polyethylene glycol plus ascorbic acid group than in the 4 L polyethylene glycol group.The 2 L polyethylene glycol plus ascorbic acid solution is a safe choice for bowel preparation before colonoscopy in patients with impaired renal function.
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Affiliation(s)
| | - Bora Keum
- Division of Gastroenterology and Hepatology
- Correspondence: Bora Keum, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine, Inchon-ro, Seongbuk-gu, Seoul, Korea (e-mail: )
| | | | | | | | | | | | | | | | | | - Soon Ho Um
- Division of Gastroenterology and Hepatology
| | | | - Myung Gyu Kim
- Division of Nephrology, Department of Internal Medicine, Korea University College of Medicine, Seongbuk-gu, Seoul, 02841, Korea
| | - Sang Kyung Jo
- Division of Nephrology, Department of Internal Medicine, Korea University College of Medicine, Seongbuk-gu, Seoul, 02841, Korea
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Oliveira MAP, Pereira TRD, Gilbert A, Tulandi T, de Oliveira HC, De Wilde RL. Bowel complications in endometriosis surgery. Best Pract Res Clin Obstet Gynaecol 2016; 35:51-62. [DOI: 10.1016/j.bpobgyn.2015.11.002] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/01/2015] [Accepted: 11/05/2015] [Indexed: 12/17/2022]
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Schaefer M, Littrell E, Khan A, Patterson ME. Estimated GFR Decline Following Sodium Phosphate Enemas Versus Polyethylene Glycol for Screening Colonoscopy: A Retrospective Cohort Study. Am J Kidney Dis 2016; 67:609-16. [PMID: 26830255 DOI: 10.1053/j.ajkd.2015.11.018] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/21/2015] [Accepted: 11/19/2015] [Indexed: 01/16/2023]
Abstract
BACKGROUND Associations between sodium phosphate enemas and nephropathy have raised concerns about the safety of use as part of a bowel-cleansing regimen administered prior to colonoscopies. The objectives of this analysis are to evaluate the impact of sodium phosphate enema versus polyethylene glycol powder for oral solution (PEG) use prior to colonoscopy screening on estimated glomerular filtration rate (eGFR) decline in Veterans Affairs (VA) patients and identify other risk factors contributing to eGFR decline. STUDY DESIGN Retrospective cohort study. SETTING & PARTICIPANTS 70,499 VA patients receiving sodium phosphate enemas (with or without PEG) or PEG alone prior to colonoscopy screenings. PREDICTOR Use of either sodium phosphate or PEG. OUTCOMES A 50% increase in serum creatinine level over a 15-month, over a 6-week, and between a 9- and 15-month period was used to define any, acute, or long-term eGFR decline, respectively. MEASUREMENTS Multivariable logistic regressions estimated the likelihood of eGFR decline conditional on the use of sodium phosphate enemas versus PEG alone, controlling for potential confounders. RESULTS A greater proportion of patients using sodium phosphate enemas versus PEG had any (P<0.001) or long-term (P=0.003) eGFR declines, whereas similar proportions had acute eGFR declines (P=0.9). In the adjusted analyses, use of sodium phosphate enemas (± PEG was associated with an increased likelihood of having any (OR, 1.3; 95% CI, 1.2-1.5) or long-term (OR, 1.4; 95% CI, 1.1-1.8) eGFR decline, but not acute eGFR decline (OR, 1.0; 95% CI, 0.6-1.7). Other risk factors for eGFR decline included diabetes and non-iron deficient anemia. LIMITATIONS Unobserved heterogeneity due to volume depletion and potential selection bias due to higher-risk patients preferentially prescribed sodium phosphate enemas. CONCLUSIONS Use of sodium phosphate enemas versus PEG alone prior to colonoscopy screening increases the risk for VA patients having long-term eGFR decline. Patients with non-iron deficient anemia are at particularly high risk for eGFR decline. These findings motivate the need to re-examine prescribing practices for sodium phosphate enemas as part of a bowel-cleansing regimen.
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Affiliation(s)
- Monica Schaefer
- Department of Veterans Affairs VISN #15, VA Heartland Network, Kansas City, MO
| | | | - Amina Khan
- Kansas City VA Medical Center, Kansas City, MO
| | - Mark E Patterson
- University of Missouri-Kansas City School of Pharmacy, Kansas City, MO.
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Hoffmanová I, Kraml P, Anděl M. Renal risk associated with sodium phosphate medication: safe in healthy individuals, potentially dangerous in others. Expert Opin Drug Saf 2015; 14:1097-110. [DOI: 10.1517/14740338.2015.1044970] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
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Layton JB, Klemmer PJ, Christiansen CF, Bomback AS, Baron JA, Sandler RS, Kshirsagar AV. Sodium phosphate does not increase risk for acute kidney injury after routine colonoscopy, compared with polyethylene glycol. Clin Gastroenterol Hepatol 2014; 12:1514-21.e3. [PMID: 24486407 PMCID: PMC5495542 DOI: 10.1016/j.cgh.2014.01.034] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/05/2013] [Revised: 01/10/2014] [Accepted: 01/10/2014] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Oral sodium phosphate (OSP) is a common bowel purgative administered before colonoscopy; the Food and Drug Administration has warned against its use because of concerns about acute kidney injury (AKI) from the absorbed phosphate and dystrophic calcification. However, it is not clear if OSP is associated with AKI in the general population or in high-risk subgroups undergoing colonoscopy. We estimated the risk of AKI among patients undergoing a screening colonoscopy using OSP vs polyethylene glycol (PEG) for bowel cleansing in a large, US-based claims database. METHODS We used an insurance database to identify a cohort of patients ages 50 to 75 years who underwent screening colonoscopies as outpatients from January 2000 through November 2008 (before the Food and Drug Administration warning), receiving OSP (n = 121,266) or PEG (n = 429,430) within 30 days beforehand, without prior use of either drug. We collected data from patients for 6 months afterward to identify those who developed AKI or renal failure, or received dialysis. Adjusted and propensity score-matched hazard ratios (HR) and 95% confidence intervals (CI) were estimated using Cox proportional hazards models. We investigated the effects in subgroups with higher AKI risk (patients with chronic kidney disease, kidney stones, hypertension, or diabetes, or using antihypertensive or nonsteroidal anti-inflammatory drugs). RESULTS AKI occurred in 0.2% of OSP users and in 0.3% of PEG users (adjusted HR, 0.86; 95% CI, 0.75-0.99). OSP users matched well with PEG users, producing similar estimates (HR, 0.85; 95% CI, 0.72-1.01). We did not observe a consistent increase in the risk of AKI or other outcomes in any subgroups analyzed. CONCLUSIONS In a large database analysis, we did not associate administration of OSP before colonoscopy with increased risk of postprocedure AKI, even in high-risk clinical subgroups.
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Affiliation(s)
- J Bradley Layton
- Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
| | - Philip J Klemmer
- Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
| | | | - Andrew S Bomback
- Department of Medicine, Columbia University, New York City, New York
| | - John A Baron
- Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
| | - Robert S Sandler
- Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
| | - Abhijit V Kshirsagar
- Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
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Lim YJ, Hong SJ. What is the best strategy for successful bowel preparation under special conditions? World J Gastroenterol 2014; 20:2741-2745. [PMID: 24659865 PMCID: PMC3961988 DOI: 10.3748/wjg.v20.i11.2741] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/08/2013] [Revised: 10/18/2013] [Accepted: 11/05/2013] [Indexed: 02/06/2023] Open
Abstract
Adequate bowel preparation is important for successful colonoscopic examination. Several effective colonic cleansing agents are available and routinely prescribed, but each carries its own limitations and benefits from particular dosing regimens. The most frequently prescribed colonic cleansing agent, the polyethylene glycol (PEG) cathartic solution, suffers from low patient compliance in general, due to its unpalatable taste and smell coupled with the large ingested volumes required. However, PEG is preferred over other cathartics for use in individuals of advanced age, sufferers of chronic kidney disease, heart failure and inflammatory bowel disease, and women who are pregnant or lactating. The laxative agents sodium phosphate (NaP) and sodium picosulfate plus magnesium citrate have been applied and have improved patient compliance and tolerance. NaP, however, should be avoided in individuals with impaired renal function or plasma clearance, such as those with chronic kidney disease, who are taking drugs that affect renal function, or who suffer from heart failure. Other special conditions that may affect an individual’s tolerance of the cathartic agent or ability to complete the administration routine include stroke, severe constipation, hematochezia, suspicious lower gastrointestinal bleeding, and mental disorders such as dementia. All ingestible bowel preparation solutions can be instilled into the stomach and duodenum through nasogastric tube or esophagogastroduodenoscope with the aid of a water irrigation pump for patients with difficulties swallowing or ingesting the large volumes of fluid required. In addition, dietary regimens based on clear liquids and low-residue foods for 1-4 d prior to the colonoscopy may be supplemental bowel preparation strategies. Achieving an effective and safe cleansing of the bowel is important for successful colonoscopy in all patients, so full knowledge of the individual’s condition and capabilities is necessary to select the most appropriate colonic cleansing agent and delivery regimen.
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Affiliation(s)
- Antoine Abcar
- Antoine Abcar, MD, is a Nephrologist at the Los Angeles Medical Center in California. E-mail:
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Smith HO, Delic L. Postoperative Surveillance and Perioperative Prophylaxis. Gynecol Oncol 2011. [DOI: 10.1002/9781118003435.ch6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/07/2022]
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Pálmadóttir VK, Gudmundsson H, Hardarson S, Arnadóttir M, Magnússon T, Andrésdóttir MB. Incidence and outcome of acute phosphate nephropathy in Iceland. PLoS One 2010; 5:e13484. [PMID: 20976065 PMCID: PMC2957439 DOI: 10.1371/journal.pone.0013484] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/18/2010] [Accepted: 09/23/2010] [Indexed: 12/20/2022] Open
Abstract
BACKGROUND Oral sodium phosphate solutions (OSPS) are widely used for bowel cleansing prior to colonoscopy and other procedures. Cases of renal failure due to acute phosphate nephropathy following OSPS ingestion have been documented in recent years, questioning the safety of OSPS. However, the magnitude of the problem remains unknown. METHODOLOGY/PRINCIPAL FINDINGS We conducted a population based, retrospective analysis of medical records and biopsies of all cases of acute phosphate nephropathy that were diagnosed in our country in the period from January 2005 to October 2008. Utilizing the complete official sales figures of OSPS, we calculated the incidence of acute phosphate nephropathy in our country. Fifteen cases of acute phosphate nephropathy were diagnosed per 17,651 sold doses of OSPS (0.085%). Nine (60%) were women and mean age 69 years (range 56-75 years). Thirteen patients had a history of hypertension (87%) all of whom were treated with either ACE-I or ARB and/or diuretics. One patient had underlying DM type I and an active colitis and one patient had no risk factor for the development of acute phosphate nephropathy. Average baseline creatinine was 81.7 µmol/L and 180.1 at the discovery of acute renal failure, mean 4.2 months after OSPS ingestion. No patient had a full recovery of renal function, and at the end of follow-up, 26.6 months after the OSPS ingestion, the average creatinine was 184.2 µmol/L. The average eGFR declined from 73.5 ml/min/1.73 m(2) at baseline to 37.3 ml/min/1.73 m(2) at the end of follow-up. One patient reached end-stage renal disease and one patient died with progressive renal failure. CONCLUSION/SIGNIFICANCE Acute phosphate nephropathy developed in almost one out of thousand sold doses of OSPS. The consequences for kidney function were detrimental. This information can be used in other populations to estimate the impact of OSPS. Our data suggest that acute phosphate nephropathy may be greatly underreported worldwide.
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Abstract
Efficient cleansing of the colon before a colonoscopy or a radiological examination is essential. The osmotically acting cathartics (those given the Anatomical Therapeutic Chemical code A06AD) currently used for this purpose comprise products based on three main substances: sodium phosphate, combinations of polyethylene glycol and electrolyte lavage solutions (PEG-ELS), and magnesium citrate. All these preparations give adequate cleansing results and have similar profiles in terms of the frequency and type of mild to moderate adverse effects. However, serious adverse events, such as severe hyperphosphatemia and irreversible kidney damage owing to acute phosphate nephropathy, have been reported after use of sodium-phosphate-based products. The aim of this Review is to provide an update on the potential safety issues related to the use of osmotically acting cathartics, especially disturbances of renal function and water and electrolyte balance. The available evidence indicates that PEG-ELS-based products are the safest option. Magnesium-citrate-based, hypertonic products should be administered with caution to elderly individuals and patients who are prone to develop disturbances in water and electrolyte balance. Sodium-phosphate-based products can occasionally cause irreversible kidney damage and should not be routinely used in bowel-cleansing procedures.
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Seol DC, Hong SN, Kim JH, Sung IK, Park HS, Lee JH, Shim CS. Change in renal function after sodium phosphate preparation for screening colonoscopy. World J Gastroenterol 2010; 16:2010-6. [PMID: 20419839 PMCID: PMC2860079 DOI: 10.3748/wjg.v16.i16.2010] [Citation(s) in RCA: 9] [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] [Indexed: 02/06/2023] Open
Abstract
AIM: To investigate the changes in renal function at 12-24 mo in patients following sodium phosphate (NaP) preparation for screening colonoscopy.
METHODS: We carried out a retrospective study on the results from patients who received health check-up services as part of an employer-provided wellness program performed between August 2006 and May 2008 and who were followed up for 12-24 mo. Prior to screening colonoscopy, 224 patients underwent bowel cleansing with NaP (NaP group) and 113 patients with polyethylene glycol (PEG group). The control group comprised 672 age-matched patients. We compared the changes in the creatinine levels and the glomerular filtration rates (GFRs) from baseline to 12-24 mo between the NaP, PEG, and control groups using two-way repeated measured analysis of variance. In addition, multivariate linear regression analysis was performed to assess the risk factors for a decreased GFR.
RESULTS: The baseline mean serum creatinine level in the NaP, PEG, and control groups was 1.12 ± 0.15, 1.12 ± 0.16, and 1.12 ± 0.15 mg/dL, which increased to 1.15 ± 0.15, 1.15 ± 0.18, and 1.15 ± 0.15 mg/dL, respectively, after 12-24 mo. The baseline mean GFR in the NaP, PEG, and control groups was 69.0 ± 7.7, 68.9 ± 8.0, and 69.6 ± 6.7 mL/min per 1.73 m2, which decreased to 66.5 ± 7.8, 66.5 ± 8.3, and 67.4 ± 6.4 mL/min per 1.73 m2, respectively, after 12-24 mo. The changes in serum creatinine levels and GFRs were not significantly between the NaP, PEG, and control groups (P = 0.992 and P = 0.233, respectively). Using multivariate linear regression analysis, only the baseline GFR was associated with the change in GFR (P < 0.001). Indeed, the bowel preparations were not associated with the change in GFR (P = 0.297).
CONCLUSION: NaP bowel preparation in subjects with normal renal function was not associated with renal injury, and NaP can thus be used safely for screening colonoscopy.
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Egbring M, Kullak-Ublick GA, Russmann S. Phynx: an open source software solution supporting data management and web-based patient-level data review for drug safety studies in the general practice research database and other health care databases. Pharmacoepidemiol Drug Saf 2010; 19:38-44. [PMID: 19777533 DOI: 10.1002/pds.1860] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
PURPOSE To develop a software solution that supports management and clinical review of patient data from electronic medical records databases or claims databases for pharmacoepidemiological drug safety studies. METHODS We used open source software to build a data management system and an internet application with a Flex client on a Java application server with a MySQL database backend. The application is hosted on Amazon Elastic Compute Cloud. This solution named Phynx supports data management, Web-based display of electronic patient information, and interactive review of patient-level information in the individual clinical context. This system was applied to a dataset from the UK General Practice Research Database (GPRD). RESULTS Our solution can be setup and customized with limited programming resources, and there is almost no extra cost for software. Access times are short, the displayed information is structured in chronological order and visually attractive, and selected information such as drug exposure can be blinded. External experts can review patient profiles and save evaluations and comments via a common Web browser. CONCLUSIONS Phynx provides a flexible and economical solution for patient-level review of electronic medical information from databases considering the individual clinical context. It can therefore make an important contribution to an efficient validation of outcome assessment in drug safety database studies.
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Affiliation(s)
- Marco Egbring
- Division of Clinical Pharmacology and Toxicology, University Hospital Zurich, 8091Zurich, Switzerland
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Amato A, Radaelli F, Paggi S, Terruzzi V. Half doses of PEG-ES and senna vs. high-dose senna for bowel cleansing before colonoscopy: a randomized, investigator-blinded trial. Am J Gastroenterol 2010; 105:675-81. [PMID: 19844199 DOI: 10.1038/ajg.2009.598] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVES Patients' compliance with and tolerance of large-volume polyethylene glycol electrolyte solution (PEG-ES) have prompted continuous investigation with alternative forms of cleansing. High-dose senna is superior to PEG-ES for the quality of bowel cleansing, patient compliance, and tolerance, but its acceptance may be influenced by the incidence of abdominal pain. We hypothesized that a combination of half doses of PEG-ES and senna could minimize the incidence of abdominal pain without affecting the quality of bowel preparation. METHODS This randomized, investigator-blinded trial has been conducted on consecutive outpatients scheduled for elective colonoscopy at a single community-based hospital. Patients were randomly assigned to receive either 12 tablets of 12 mg senna and 2 l of PEG-ES (half-dose group, HDG) or 24 tablets of senna divided in two doses (senna group, SG) the day before colonoscopy. The main outcome measures were the quality of colon cleansing (Aronchick scoring scale) and the incidence of preparation-related abdominal pain. Secondary outcome measures were patients' compliance with the cleansing regimen, overall tolerability, prevalence of predefined side effects, and quality of right colon cleansing. RESULTS A total of 296 patients were enrolled (HDG=151 and SG=145). Overall cleansing was excellent to good in 90.1 and 88.3% patients in HDG and SG, respectively (P=0.62). Preparation-related moderate-to-severe abdominal pain was reported by 6% patients in HDG and 15.2% in SG (P=0.009). No significant differences were observed for secondary outcomes. CONCLUSIONS The regimen combining half doses of PEG-ES and senna provides high-quality bowel preparation and acceptable patient tolerance, with less abdominal pain compared with high-dose senna.
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Affiliation(s)
- Arnaldo Amato
- Department of Gastroenterology, Valduce Hospital, Como, Italy
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Pelham RW, Alcorn H, Cleveland MVB. A pharmacokinetics evaluation of a new, low-volume, oral sulfate colon cleansing preparation in patients with renal or hepatic impairment and healthy volunteers. J Clin Pharmacol 2010; 50:350-4. [PMID: 20067942 DOI: 10.1177/0091270009339741] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
The pharmacokinetics (PK) of an oral sulfate solution (OSS) for bowel cleansing preparation was studied. OSS (30 g of sulfate) was split between 2 doses, 12 hours apart. Safety measures included electrocardiography, vital signs, adverse events, hematology, blood chemistry, and urinalysis. Six adult patients with moderate renal disease (MRD), 6 with mild-moderate hepatic disease (M/MHD), and 6 normal healthy volunteers (NHVs) completed the study. Adverse events were mild to moderate in severity and were mainly limited to headache and expected gastrointestinal symptoms. Serum sulfate levels were highly variable at all times, even after adjusting for baseline. Sulfate was higher in MRD in comparison to the other groups. The C(max) and AUC were higher in the patients, but no statistically significant differences emerged. Sulfate levels returned to predose values within 54 hours after dosing. No electrolyte disturbances occurred. Urinary sulfate excretion was approximately 20% of the dose. OSS was well tolerated. The types and severity of adverse events were similar to those seen in large phase III trials. While patients with MRD had elevated sulfate, the levels were less than those in renal failure and did not alter biochemical parameters that are associated with hypersulfatemia.
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Affiliation(s)
- Russell W Pelham
- Pharmacology and Toxicology, Braintree Laboratories Inc, Braintree, MA 02185, USA
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Abstract
Acute phosphate nephropathy (APhN) is a clinical pathological entity characterized by acute and subsequent chronic renal failure following exposure to oral sodium phosphate (OSP) bowel purgatives. Renal biopsy findings include acute and chronic tubular injury with prominent tubular and interstitial calcium phosphate deposits. Risk factors for APhN include older age, female gender, hypertension, chronic kidney disease (CKD), and treatment with angiotensin converting enzyme inhibitors, angiotensin receptor blockers, and diuretics. The pathomechanism of APhN involves hypovolemia-induced avid proximal salt and water reabsorption, delivery of a large phosphate load to the distal nephron, and precipitation of calcium phosphate in the distal tubule and collecting duct. To date, 37 cases of biopsy-proven APhN have been reported, and epidemiologic studies have produced inconsistent results regarding the incidence of acute kidney injury (AKI) following the use of OSP purgatives. OSP solution was withdrawn from the market in December of 2008, but OSP tablets, offered by prescription only, remain available. Prevention of APhN is best achieved by avoiding OSP in high-risk patients, aggressive hydration before, during, and after OSP administration, minimizing the dose of OSP, and maintaining a minimum of a 12 h interval between OSP administrations.
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Colonoscopy: Oral sodium phosphate may worsen kidney dysfunction. Nat Rev Gastroenterol Hepatol 2009; 6:201-3. [PMID: 19347009 DOI: 10.1038/nrgastro.2009.41] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/08/2022]
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John Wiley & Sons, Ltd.. Current awareness: Pharmacoepidemiology and drug safety. Pharmacoepidemiol Drug Saf 2009. [DOI: 10.1002/pds.1646] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
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