Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation to Enhance the Colonoscopy Preparation Quality in an Indian Tertiary Care Center.
18 Years
75 Years
Both
Colorectal Carcinoma
Trial Information
Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation to Enhance the Colonoscopy Preparation Quality in an Indian Tertiary Care Center.
Objectives:
1. 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
2. Secondary:
- Quality of bowel preparation without Dietary restriction (Modified bowel
preparation regime without Fiber diet restrictions)
Inclusion Criteria:
1. All adult patient referred for colonoscopy to AIG
2. Age 18 - 75 years old
Exclusion Criteria:
1. Acute GI bleeding.
2. Patient of bowel preparation regime other than excepted for the study.
3. Renal insufficiency.
4. Dementia.
5. Symptomatic heart failure.
6. Recent Myocardial Infarction.
7. Patients with ileus.
8. Suspected bowel obstruction.
9. Prior alimentary tract surgery.
10. Significant gastroparesis.
11. Gastric outlet obstruction.
12. Toxic colitis or megacolon.
13. Pregnant or lactating patients.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Outcome Measure:
Quality of bowel preparation in Same day Low volume PEG with placebo versus same day low volume PEG with Lubiprostone
Outcome Description:
Quality of bowel preparation is based on Boston Bowel Preparation Score (BBPS)
Outcome Time Frame:
2 months
Safety Issue:
Yes
Principal Investigator
Nageshwar D Reddy, MD. DM
Investigator Role:
Study Director
Investigator Affiliation:
Asian Institute of Gastroenterolgy India
Authority:
India: Institutional Review Board
Study ID:
AIG-GI2011-01
NCT ID:
NCT01324284
Start Date:
March 2011
Completion Date:
June 2011
Related Keywords:
- Colorectal Carcinoma
- Lubiprostone
- Bowel preparation regime
- Carcinoma
- Colorectal Neoplasms
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