Skip to main content
Clinical Trials/NCT02119000
NCT02119000
Terminated
Phase 4

Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy

McGill University Health Centre/Research Institute of the McGill University Health Centre2 sites in 1 country82 target enrollmentAugust 2015

Overview

Phase
Phase 4
Intervention
PEG/electrolytes 2L/2L split dose
Conditions
Hospitalized Patients
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
82
Locations
2
Primary Endpoint
Efficacy
Status
Terminated
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
January 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Alan Barkun

Gastroenterologist

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Patient refusal
  • A suspected or diagnosed bowel obstruction
  • A toxic megacolon
  • 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

Arms & Interventions

PEG electrolytes 2L/2L split dose

Intervention: PEG/electrolytes 2L/2L split dose

Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose

Intervention: Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose

Outcomes

Primary Outcomes

Efficacy

Time Frame: 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 Outcomes

  • Tolerability(Before colonoscopy)
  • Clinical quality standards(After colonoscopy)
  • Cecal/ileal intubation rate(Following colonoscopy)
  • Polyp detection rate(Following colonosopy)

Study Sites (2)

Loading locations...

Similar Trials