Colonoscopy Preparation Optimization for INpatients- COIN Study

NCT01627171 | Unknown Phase 4

• 1 other identifier: RP 12-3657
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Ottawa Bowel Prep Score

  Using a standardized, validated score for measuring quality of bowel preparation

  30 minutes after procedure

Secondary Outcomes (4)

• Procedures Cancelled or repeated due to inadequate bowel preparation

  During admission (average of 2 weeks)

• Individual Components of Ottawa Bowel Prep Score

  30 minutes after procedure

• Adverse Effects

  Up to 48 hours after procedure

• Tolerability of the preparation

  Within 1 day of intervention

Study Arms (3)

PEG Lyte

ACTIVE COMPARATOR

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

Drug: Bisacodyl 10mg; Drug: Polyethelene Glycol

Pico Salax Split

EXPERIMENTAL

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

Drug: Bisacodyl 10mg; Drug: Picosulfate sodium

Pico Salax Night Before

EXPERIMENTAL

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

Drug: Bisacodyl 10mg; Drug: Picosulfate sodium

Interventions

Bisacodyl 10mg DRUG

Given at the start of the bowel preparation the day before colonoscopy

PEG Lyte; Pico Salax Night Before; Pico Salax Split

Polyethelene Glycol DRUG

280g reconstituted in 4 liters of water

Also known as: PEG-Lyte

PEG Lyte

Picosulfate sodium DRUG

Two sachets, Each sachet has 10mg dose

Also known as: Pico-Salax

Pico Salax Night Before; Pico Salax Split

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• McMaster University: collaborator

Study Sites (1)

St Joseph Hospital

Hamilton, Ontario, L8N4A6, Canada

RECRUITING

MeSH Terms

Interventions

Bisacodyl; picosulfate sodium; Pico-Salax

Intervention Hierarchy (Ancestors)

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

Study Officials

• Khurram J Khan, MD, BSc

  St Josephs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Balogh Melanson, BSc

CONTACT

905-522-1155; lbalogh@stjosham.on.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 25, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 30, 2013

Record last verified: 2013-01

Locations

CA (1)