NCT01627171

Colonoscopy Preparation Optimization for INpatients- COIN Study

A Randomized Control Trial Comparing 4L PEGlyte to Regular Dose Pico-Salax and Split Dose Pico-Salax for Colonoscopy Bowel Preparation in Hospitalized Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Colonoscopic examinations are performed routinely in hospitalized patients for a variety of indications. However, numerous limitations exist in hospitalized patients preventing an endoscopist from performing high quality examinations; possibly necessitating repeated procedures leading to increased cost and re-exposure to their inherent risks. One such prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown to be a predictor of poor bowel preparation as these patients are older, less mobile and have more co morbidities than the outpatient population. Currently, no standardized (or optimized) bowel preparation type or regimen for administration exists for the hospital inpatient population undergoing colonoscopy. Studies in the outpatient population have demonstrated that timing and choice of cathartic medication effects the cleanliness of the bowel preparation but there is no such clinical evidence for in-patients who receive whatever cathartic agent is on hospital formulary. The purpose of the study is compare efficacy, patient satisfaction, and adverse effects associated with low volume cathartic (Pico-Salax) to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate timing of dosages.

Conditions

• Endoscopy
• Bowel Preparation Solutions

Interventions

Type	Name	Description
DRUG	Bisacodyl 10mg	Given at the start of the bowel preparation the day before colonoscopy
DRUG	Polyethelene Glycol	280g reconstituted in 4 liters of water
DRUG	Picosulfate sodium	Two sachets, Each sachet has 10mg dose

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-06-25
• Last updated: 2013-01-30

Locations

1 site across 1 country: Canada