Colonoscopy Preparation Optimization for INpatients- COIN Study

Study Overview
=================
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.

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

Conditions
-----------------
Endoscopy, Bowel Preparation Solutions

Intervention / Treatment
-----------------
* Drug: Bisacodyl 10mg
* Drug: Polyethelene Glycol
* Drug: Picosulfate sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEG Lyte<br>PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy. | Drug: Bisacodyl 10mg<br>* Given at the start of the bowel preparation the day before colonoscopy<br>Drug: Polyethelene Glycol<br>* 280g reconstituted in 4 liters of water<br>* Other names: PEG-Lyte;|
| Experimental: Pico Salax Split<br>Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy. | Drug: Bisacodyl 10mg<br>* Given at the start of the bowel preparation the day before colonoscopy<br>Drug: Picosulfate sodium<br>* Two sachets, Each sachet has 10mg dose<br>* Other names: Pico-Salax;|
| Experimental: Pico Salax Night Before<br>2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy | Drug: Bisacodyl 10mg<br>* Given at the start of the bowel preparation the day before colonoscopy<br>Drug: Picosulfate sodium<br>* Two sachets, Each sachet has 10mg dose<br>* Other names: Pico-Salax;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ottawa Bowel Prep Score | Using a standardized, validated score for measuring quality of bowel preparation | 30 minutes after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| Adverse Effects | Any adverse effects that may be attributed to the intervention | Up to 48 hours after procedure | 
| Tolerability of the preparation | A questionnaire to assess the overall tolerability of the preparation. | Within 1 day of intervention |