Colonoscopy Preparation Optimization for INpatients- COIN Study

Endoscopy Clinical Trial

— COIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01627171
• Other study ID #: RP 12-3657
• Status: Recruiting
• Phase: Phase 4
• First received: June 19, 2012
• Last updated: January 28, 2013
• Start date: September 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2013
• Source: St. Joseph's Healthcare Hamilton
• Contact: Lisa Balogh Melanson, BSc
• Phone: 905-522-1155
• Email: lbalogh[@]stjosham.on.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Preparation Solutions
• Endoscopy

Intervention

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

Locations

Country	Name	City	State
Canada	St Joseph Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ottawa Bowel Prep Score	Using a standardized, validated score for measuring quality of bowel preparation	30 minutes after procedure	No
Secondary	Procedures Cancelled or repeated due to inadequate bowel preparation	If bowel preparation is deemed inadequate to the point the procedure must be cancelled or rescheduled	During admission (average of 2 weeks)	No
Secondary	Individual Components of Ottawa Bowel Prep Score	Each section of prep score evaluating the right, mid, and left colon, as well as the fluid score will be analyzed individually	30 minutes after procedure	No
Secondary	Adverse Effects	Any adverse effects that may be attributed to the intervention	Up to 48 hours after procedure	Yes
Secondary	Tolerability of the preparation	A questionnaire to assess the overall tolerability of the preparation.	Within 1 day of intervention	No