Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy

NCT ID: NCT02119000

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2020-01-31

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.

Conditions

Hospitalized Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PEG electrolytes 2L/2L split dose

Group Type: EXPERIMENTAL

PEG/electrolytes 2L/2L split dose

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Alan Barkun

Gastroenterologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McGill University Health Centre

Montreal, Quebec, Canada

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

GEN 13-148

Identifier Type: -

Identifier Source: secondary_id

GEN 13-148

Identifier Type: -

Identifier Source: org_study_id