Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Lubiprostone as an adjunct to the standard bowel preparation regime the quality of bowel preparation can be improved for a good colonoscopic examination without missing lesions and complications.

Detailed Description
-----------------
Objectives: Primary: Same day Low volume PEG with placebo (Arm 1) versus same day low volume PEG with Lubiprostone (Arm 2) Waiting time for colonoscopic procedure and quality of bowel preparation Secondary: Quality of bowel preparation without Dietary restriction (Modified bowel preparation regime without Fiber diet restrictions)

Official Title
-----------------
Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation to Enhance the Colonoscopy Preparation Quality in an Indian Tertiary Care Center.

Conditions
-----------------
Colorectal Carcinoma

Intervention / Treatment
-----------------
* Drug: Lubiprostone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patient referred for colonoscopy to AIG Age 18 - 75 years old Exclusion Criteria: Acute GI bleeding. Patient of bowel preparation regime other than excepted for the study. Renal insufficiency. Dementia. Symptomatic heart failure. Recent Myocardial Infarction. Patients with ileus. Suspected bowel obstruction. Prior alimentary tract surgery. Significant gastroparesis. Gastric outlet obstruction. Toxic colitis or megacolon. Pregnant or lactating patients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lubiprostone<br>Lubiprostone with PEG solution versus Placebo with PEG solution | Drug: Lubiprostone<br>* Lubiprostone is a chloride channel activator approved by the Food and Drug Administration for the treatment of chronic constipation. A randomized, double-blind, parallel-group, placebo-controlled study evaluating the effect of lubiprostone on gastric function showed slowed gastric emptying and increased small bowel and colonic transit time. Peak plasma concentration was shown to be around 1.14 hours, with a majority of the drug excreted in the urine within 48 hours.<br>|
| Placebo Comparator: lubiprostone versus placebo<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of bowel preparation in Same day Low volume PEG with placebo versus same day low volume PEG with Lubiprostone | Quality of bowel preparation is based on Boston Bowel Preparation Score (BBPS) | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lubiprostone, Bowel preparation regime