Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy

Phase 4

Terminated

• Conditions: Hospitalized Patients
• Interventions: Drug: PEG/electrolytes 2L/2L split dose; Drug: Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose

• Registration Number: NCT02119000
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

Bowel preparation is a crucial step prior to colonoscopy to help with the optimal assessment of the colonic mucosa. Inadequate bowel preparation increases the length of the procedure, and is associated with decreased lesional detection rates. The ideal bowel preparation formulation should be able to completely clean the bowel, without leaving solid or liquid residues, and without modifying the mucosal appearance.

Bowel preparation may be administered in hospitalised patients or in the ER. Patients have less control on their environment and the intake of the bowel preparation. For example, there may be a delay in pharmacy delivery or inadequate supervision by the treating personnel. Hospitalised patients have more comorbidities, are usually less autonomous and mobile - both can add to the barriers leading to an adequate bowel preparation. Multiple studies have identified hospitalization status as an independent risk factor for poor bowel preparation.

The objective of this study is to access which bowel preparation regimen, between PEG 3350 with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG 3350 with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the cleanest bowel preparation in hospitalised patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-26
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-21
• Study Start: 2015-08
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

• Patient refusal
• A suspected or diagnosed bowel obstruction
• A toxic megacolon
• Ileus
• Decompensated heart failure
• Severe acute renal failure
• Severe electrolyte imbalance
• Previous bowel preparation in the last 7 days
• Pregnancy
• Time of randomization before 9h00 or after 22h00

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PEG electrolytes 2L/2L split dose	PEG/electrolytes 2L/2L split dose	-
Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose	Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose	-

Primary Outcome Measures

Name	Time	Method
Efficacy	following colonoscopy	Which bowel preparation regimen, between PEG 3350 with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG 3350 with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the cleanest bowel preparation in hospitalised patients.

Secondary Outcome Measures

Name	Time	Method
Tolerability	Before colonoscopy	A questionnaire will be used to assess which is the most tolerable and acceptable to patients between the two bowel preparation regimens
Clinical quality standards	After colonoscopy	Does the bowel preparation given prior to in-hospital colonoscopy result in an excellent or good preparation rate that falls within the required clinical quality standards?
Cecal/ileal intubation rate	Following colonoscopy	What is the cecal/ileal intubation rate for colonoscopies performed in hospitalized patients?
Polyp detection rate	Following colonosopy	What is the polyp detection rate for colonoscopies performed in hospitalized patients?

Trial Locations

Locations (2)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada