Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy

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.

Study Overview

• Status: Terminated
• Conditions: Hospitalized Patients
• Intervention / Treatment: Drug: PEG/electrolytes 2L/2L split dose; Drug: Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G1A4
      • McGill University Health Centre
    • Sherbrooke, Quebec, Canada, J1G 2E8
      • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• 18 years or older
• Be able to comprehend the trial and provide written informed consent in French or English, or a close relative with power of attorney
• Have a recognised indication for full colonoscopy after evaluation by a gastroenterologist or surgeon
• Be hospitalized or in the ED of a participating hospital center.
• Need to receive a bowel preparation during hospitalization or the ED stay.
• Be able to complete the follow-up patient response form in French or English

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEG electrolytes 2L/2L split dose	Drug: PEG/electrolytes 2L/2L split dose; Polyethylene glycol 17gm X 4 At 18h00 the day prior the colonoscopy, dilute 2 sachets in 2 L of water and drink 240 mL every 10 minutes On the day of the procedure, 4-5 hours prior the colonoscopy, dilute 2 sachets in 2 L of water and drink 240 mL every 10 minutes
Active Comparator: Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose	Drug: Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose; Bisacodyl 15 mg x 3 At 14h00 the day prior the endoscopic procedure: take 3 tablets of Bisacodyl ER (15 mg) orally then 5 hr later: PEG/electrolytes 1L/1L Polyethylene glycol 17gm Dilute one sachet of Polyethylene glycol 17gm in 1 L of water Start drinking at around 19h00 the night prior the colonoscopy Drink 240 ml every 10 minutes The day of the colonoscopy. At (4 hrs prior the procedure). Dilute on sachet of PEG and drink 240 ml every 10 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	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.	following colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability	A questionnaire will be used to assess which is the most tolerable and acceptable to patients between the two bowel preparation regimens	Before colonoscopy
Clinical quality standards	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?	After colonoscopy
Cecal/ileal intubation rate	What is the cecal/ileal intubation rate for colonoscopies performed in hospitalized patients?	Following colonoscopy
Polyp detection rate	What is the polyp detection rate for colonoscopies performed in hospitalized patients?	Following colonosopy

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: January 26, 2014
• First Submitted That Met QC Criteria: April 17, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Laxatives; Bisacodyl
• Other Study ID Numbers: GEN 13-148