Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy

NCT02119000 | Terminated Phase 4

• 1 other identifier: GEN 13-148
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Tolerability

  Before colonoscopy

• Clinical quality standards

  After colonoscopy

• Cecal/ileal intubation rate

  Following colonoscopy

• Polyp detection rate

  Following colonosopy

Study Arms (2)

PEG electrolytes 2L/2L split dose

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

PEG/electrolytes 2L/2L split dose 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

PEG electrolytes 2L/2L split dose

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

McGill University Health Centre

Montreal, Quebec, H3G1A4, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1G 2E8, Canada

Location

MeSH Terms

Interventions

Bisacodyl

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Study Record Dates

• First Submitted: January 26, 2014
• First Posted: April 21, 2014
• Study Start: August 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

CA (2)