Colonoscopy Preparation Optimization for INpatients- COIN Study

St. Joseph's Healthcare Hamilton

Status and phase: Unknown; Phase 4

Conditions: Bowel Preparation Solutions; Endoscopy

Treatments: Drug: Polyethelene Glycol; Drug: Picosulfate sodium; Drug: Bisacodyl 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01627171

RP 12-3657

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inpatient colonoscopy
• Age greater than 18 years old
• Able to give consent

Exclusion criteria

• No consent obtained
• Pregnancy or lactating
• Renal impairment
• Severe CHF (NYHA class 3/4)
• Recent myocardial infarction (preceding 6 months)
• Ileus
• Ascites
• Severe Colitis
• Toxic Megacolon
• Gastrointestinal Obstruction
• PEG tube
• Previous large bowel resection
• Allergy to study drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 3 patient groups

PEG Lyte

Active Comparator group

Description:

PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy.

Treatment:

Drug: Polyethelene Glycol

Drug: Bisacodyl 10mg

Pico Salax Split

Experimental group

Description:

Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy.

Treatment:

Drug: Picosulfate sodium

Drug: Bisacodyl 10mg

Pico Salax Night Before

Experimental group

Description:

2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy

Treatment:

Drug: Picosulfate sodium

Drug: Bisacodyl 10mg