Prospective single-blinded single-center randomized controlled trial of Prep Kit-C and Moviprep: Does underlying inflammatory bowel disease impact tolerability and efficacy?

doi:10.3748/wjg.v27.i11.1090

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World Journal of Gastroenterology

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Clinical Trials Study

World J Gastroenterol. Mar 21, 2021; 27(11): 1090-1100
Published online Mar 21, 2021. doi: 10.3748/wjg.v27.i11.1090

Prospective single-blinded single-center randomized controlled trial of Prep Kit-C and Moviprep: Does underlying inflammatory bowel disease impact tolerability and efficacy?

Waled Mohsen, Astrid-Jane Williams, Gabrielle Wark, Alexandra Sechi, Jenn-Hian Koo, Wei Xuan, Milan Bassan, Watson Ng, Susan Connor

Waled Mohsen, Department of Digestive Diseases, Gold Coast University Hospital, Gold Coast, 4215, Queensland, Australia

Waled Mohsen, Astrid-Jane Williams, Gabrielle Wark, Alexandra Sechi, Jenn-Hian Koo, Milan Bassan, Watson Ng, Susan Connor, Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia

Astrid-Jane Williams, Wei Xuan, Watson Ng, Susan Connor, South West Sydney Clinical School, University of New South Wales, Sydney 2170, New South Wales, Australia

Wei Xuan, Susan Connor, Ingham Institute Applied Medical Research, Sydney 2170, New South Wales, Australia

Author contributions: Mohsen W and Williams AJ collected data, compiled data, blinded endoscopist (fellow), recruited patients from clinic, organized spreadsheet, developed tables, liaised wrote the manuscript; Wark G collected data and developed the figures; Sechi A inflammatory bowel disease nurse consultant who assisted with education, recruitment of patients and answering patient concerns during the trial process; Koo JH blinded assisted with manuscript review, study design and statistical analysi; Xuan W is statistician from the Ingham institute who assisted with the statistical analysis; Bassan M assisted with the review of the manuscript; Ng W recruited patients, assisted with study design and assisted with review process and manuscript development; Connor S developed study design and end points for the study, applied for ethics approval, assisted with the development of the manuscript.

Institutional review board statement: Approval was obtained from the Institutional Human Ethics and Research Office (reference HREC/12/LPOOL/108).

Clinical trial registration statement: There was no clinical trial registration for this study.

Informed consent statement: Informed consent form was not required for this study as this was a prospective single blinded single centre study.

Conflict-of-interest statement: All of the authors have no conflict of interest to disclose. We did not receive commercial or government funding for this article.

Data sharing statement: All data included in this study is deidentified.

CONSORT 2010 statement: The authors have read the CONSORT 2010 statement of items, and the manuscript was prepared and revised according to the CONSORT 2010 statement of items.

Corresponding author: Waled Mohsen, FRACP, Gastroenterologist, Department of Digestive Diseases, Gold Coast University Hospital, Gold Coast 4215, Queensland, Australia. wmoh6298@uni.sydney.edu.au

Received: November 1, 2020
Peer-review started: November 1, 2020
First decision: November 30, 2020
Revised: January 11, 2021
Accepted: March 7, 2021
Article in press: March 7, 2021
Published online: March 21, 2021
Processing time: 128 Days and 21.4 Hours

Abstract

BACKGROUND

Colonoscopy remains the gold standard for detection of colonic disease. An optimal evaluation depends on adequate bowel cleansing. Patients with inflammatory bowel disease (IBD), require frequent endoscopic assessment for both activity and dysplasia assessment. Two commonly used bowel preparations in Australia are Prep Kit-C (Pc) and Moviprep (Mp). Little is known about tolerability, efficacy and safety of split protocols of Mp and Pc in both IBD and non-IBD patients.

AIM

To primary aim was to compare the tolerability, efficacy and safety of split protocols of Mp and Pc in patients having a colonoscopy. The secondary aim was to compare the efficacy, tolerability and safety of either preparation in patients with or without IBD.

METHODS

Patients were randomized to Pc or Mp bowel preparation. Patients completed a questionnaire to assess tolerability. Efficacy was assessed using the Ottawa Bowel Preparation Score. Serum electrolytes and renal function were collected one week prior to colonoscopy and on the day of colonoscopy.

RESULTS

Of 338 patients met the inclusion criteria. Of 168 patients randomized to Mp and 170 to Pc. The efficacy of bowel preparation (mean Ottawa Bowel Preparation Score) was similar between Mp (5.4 ± 2.4) and Pc (5.1 ± 2.1) (P = 0.3). Mean tolerability scores were similar in Mp (11.84 ± 5.4) and Pc (10.99 ± 5.2; P = 0.17). 125 patients had IBD (73 had Crohn’s Disease and 52 had Ulcerative colitis). Sixty-four IBD patients were allocated to Mp and 61 to Pc. In non-IBD patients, 104 were allocated to Mp and 109 to Pc. The mean tolerability score in the IBD group was lower than the non-IBD group (mean tolerability scores: IBD: 10.3 ± 5.1 and non-IBD: 12.0 ± 5.3; P = 0.01). IBD patients described more abdominal pain with Mp when compared with Pc; (Mp: 5.7 ± 4.4 vs Pc: 3.6 ± 2.6, P = 0.046). Serum magnesium level increased with Pc compared with Mp in all patients (mean increase in mmol/L: Mp: 0.03 ± 0.117 and Pc: 0.11 ± 0.106; P < 0.0001).

CONCLUSION

In this study, the efficacy, tolerability and safety of Mp and Pc were similar in all patients. However, patients with IBD reported lower tolerability with both preparations. Specifically, IBD patients had more abdominal pain with Mp. These results should be considered when recommending bowel preparation especially to IBD patients.

Keywords: Bowel preparation; Inflammatory bowel disease; Tolerability; Efficacy; Moviprep; Prep Kit-C

Core Tip: When comparing Moviprep (Mp) and Prep-Kit C (Pc) in patients with and without inflammatory bowel disease (IBD): (1) Efficacy, tolerability and safety of Mp and Pc are similar; (2) Participants with IBD reported lower tolerability with both preparations; (3) IBD participants described more abdominal pain with Mp. Consideration of these results are important when discussing bowel preparation with IBD patients.