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Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy

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McGill University

Status and phase

Terminated
Phase 4

Conditions

Hospitalized Patients

Treatments

Drug: Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose
Drug: PEG/electrolytes 2L/2L split dose

Study type

Interventional

Funder types

Other

Identifiers

NCT02119000
GEN 13-148

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

82 participants in 2 patient groups

PEG electrolytes 2L/2L split dose
Experimental group
Treatment:
Drug: PEG/electrolytes 2L/2L split dose
Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose
Active Comparator group
Treatment:
Drug: Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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