Clinical trial NCT02119000: Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hospitalized Patients
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Efficacy
timeFrame: following colonoscopy
Secondary outcomes:
measure: Tolerability
timeFrame: Before colonoscopy
measure: Clinical quality standards
timeFrame: After colonoscopy
measure: Cecal/ileal intubation rate
timeFrame: Following colonoscopy
measure: Polyp detection rate
timeFrame: Following colonosopy
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
References: