Dataset Information

Multicentre endoscopist-blinded randomised clinical trial to compare two bowel preparations after a colonoscopy with inadequate cleansing: a study protocol.

ABSTRACT: INTRODUCTION:Inadequate bowel preparation is common and negatively impacts colonoscopy quality. The objective of this study is to compare two bowel preparation regimens in cleansing the colon after an index colonoscopy with failed bowel preparation. METHODS AND ANALYSIS:This is a phase III, multicentre, randomised clinical trial comparing two bowel preparation regimens after failure to adequately cleanse at the index colonoscopy. Regimen A consists of 4?L split-dose polyethylene glycol electrolyte solution (PEG-ELS) and Regimen B consists of 6?L split-dose PEG-ELS, both preceded by 15?mg of bisacodyl the day before the procedure along with a low-fibre diet 3 and 2?days before the procedure followed by a clear fluid diet starting the day before the procedure. The primary outcome is adequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) score of ?6 with each segment score ?2. Secondary outcomes include mean BBPS score, bowel preparation adequacy using the US Multi-Society Task Force on Colorectal Cancer definition, detection rate by polyp subtype, caecal intubation rate, mean Validated Patient Tolerability Questionnaire for Bowel Preparation score, subject willingness to repeat the preparation and faecal incontinence rate. ETHICS AND DISSEMINATION:The study will be conducted in accordance with Good Clinical Practice guidelines and local institutional standards. Study findings will be disseminated at an international gastroenterology conference and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT02976805; Pre-results.

SUBMITTER: Sey MSL

PROVIDER: S-EPMC6629449 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Multicentre endoscopist-blinded randomised clinical trial to compare two bowel preparations after a colonoscopy with inadequate cleansing: a study protocol.

Sey Michael Sai Lai MSL von Renteln Daniel D Sultanian Richard R McDonald Cassandra C Martel Myriam M Barkun Alan A

BMJ open 20190709 7

<h4>Introduction</h4>Inadequate bowel preparation is common and negatively impacts colonoscopy quality. The objective of this study is to compare two bowel preparation regimens in cleansing the colon after an index colonoscopy with failed bowel preparation.<h4>Methods and analysis</h4>This is a phase III, multicentre, randomised clinical trial comparing two bowel preparation regimens after failure to adequately cleanse at the index colonoscopy. Regimen A consists of 4 L split-dose polyethylene g ...[more]

PMID: 31289092

Similar Datasets

Project description:Abstract Aims Failed bowel preparation is common during colonoscopy, yet the optimal purgative regimen to use for the next attempt is unknown. The objective of this study was to compare the efficacy, tolerability, and safety of two regimens at supratherapeutic doses for use after failed bowel preparation. Methods A multi-centre phase III endoscopist blinded randomized controlled trial (NCT02976805) was conducted in patients who failed bowel preparation, using the US Multi-Society Task Force (USMSTF) definition of inability to exclude polyps >5 mm in size and requiring a shortened interval to next colonoscopy. Regimen A consisted of 15 mg of bisacodyl and 2 + 2 L of split dose polyethylene glycol electrolyte solution (PEG) and Regimen B consisted of 15 mg of bisacodyl and 4 + 2 L of split dose PEG. The primary outcome was adequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) total score ≥ 6 with all segment scores ≥ 2. Secondary outcomes were adequate bowel preparation using the USMSTF definition, median BBPS, adenoma detection (ADR), advanced adenoma detection (aADR), sessile serrated polyp detection (SSPDR), and cecal intubation (CIR). Adverse events were assessed at the time of the colonoscopy and 14 days later. Results Between February 2017 and December 2019, 250 subjects were screened at four academic centres in Canada, of which 195 were randomized: 96 to Regimen A and 99 to Regimen B. The mean (SD) age was 60.6 (11.4) years, 87 (45.1%) were female, and the median (IQR) total BBPS score at previous failed colonoscopy was 3 (1,4). Regimen B was not superior to Regimen A in achieving adequate bowel preparation using the BBPS definition (87.6% vs. 91.1%, p=0.45) or the USMSTF definition (85.4% vs 91.1%, p=0.24), nor was it superior with respect to the median BBPS score (7 vs 7, p=0.50), mean ADR (31.5% vs 37.8%, p=0.37), aADR (11.2% vs 18.9%, p=0.15), SSPDR (5.6% vs 8.9%, p=0.40) or CIR (92.1% vs 96.7%, p=0.19). Regimen A had a higher adherence rate (88.2% vs. 74.7%, p=0.02) and greater willingness to undergo the bowel preparation again (91.2% vs. 66.2%, p<0.001). The only serious adverse event occurred in a patient randomized to Regimen B who was admitted to hospital for vomiting after colonoscopy. Conclusions Split dose 4L PEG with 15mg of bisacodyl is highly efficacious, well tolerated, and can be used for patients who previously failed first line bowel preparations. The additional 2L of PEG in Regimen B did not improve bowel preparation and was not as well tolerated. Funding Agencies AMOSO Opportunities Grant, Pharmascence Inc.

Project description:BackgroundAdults with cystic fibrosis (CF) have been reported to be at five to ten-fold risk (25 to 30 fold risk after solid organ transplant) of colorectal cancer (CRC) than the general population. Limited publications to date have reported on practical aspects of achieving adequate colonic cleanse producing good visualisation. In this study, we compared two bowel preparation regimens, standard bowel preparation and a modified CF bowel preparation.MethodsA non-randomised study of adults with CF attending a single centre, requiring colonoscopy investigation were selected. Between 2001 and 2015, 485 adults with CF attended the clinic; 70 adults with CF had an initial colonoscopy procedure. After five exclusions, standard bowel preparation was prescribed for 27 patients, and modified CF bowel preparation for 38 patients. Demographic and clinical data were collected for all consenting patients.ResultsThere was a significant difference between modified CF bowel preparation group and standard bowel preparation group in bowel visualisation outcomes, with the modified CF bowel preparation group having a higher proportion of "excellent/good" GI visualisation cleanse (50.0% versus 25.9%) and lower rates of "poor" visualisation cleanse (10.5% versus 44.5%) than standard bowel preparation (p = 0.006). Rates of "fair" GI cleanse visualisation were similar between the two groups (39.4% versus 29.6%) (Additional file 1: Table S1). Detection rates of adenomatous polyps at initial colonoscopy was higher in modified CF bowel preparation cohort than with standard preparation group (50.0% versus 18.5%, p < 0.01). Positive adenomatous polyp detection rate in patient's age > 40 years of age was higher (62.5%) than those < 40 years of age (24.3%) (p = 0.003). Colonic adenocarcinoma diagnosis was similar in both groups.ConclusionThis study primarily highlights that standard colonoscopy bowel preparation is often inadequate in patients with CF, and that colonic lavage using modified CF bowel preparation is required to obtain good colonic visualisation. A higher rate of polyps in patients over 40 years of age (versus less than 40 years) was evident. These results support adults with CF considered for colonoscopy screening at 40 years of age, or prior to this if symptomatic; which is earlier than CRC screening in the non-CF Australian population.

Dataset Information

Multicentre endoscopist-blinded randomised clinical trial to compare two bowel preparations after a colonoscopy with inadequate cleansing: a study protocol.

Publications

Multicentre endoscopist-blinded randomised clinical trial to compare two bowel preparations after a colonoscopy with inadequate cleansing: a study protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets