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Clinical Trial Summary

This is a prospective randomized study which will be done at main campus Cleveland Clinic. The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the evening before or as split-dose on the evening before and on the day of the procedure.


Clinical Trial Description

The purpose of our study is to determine if a 4L bowel cleansing agent is more effective than a low volume bowel preparation, and if the time of dosing (single dose night before vs split dose) of the bowel preparation results in better bowel cleansing in participants undergoing colonoscopy. Eligible participants undergoing colonoscopy with conscious sedation will be randomly assigned to one of two bowel preparations and one of two dosing schemas of bowel preparation. Participants not eligible for conscious sedation and are undergoing colonoscopy with general anesthesia will be randomized only to the single dose arms of the study. Participants will complete a questionnaire while drinking the bowel preparation to determine timing and tolerability of the bowel preparation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03198221
Study type Interventional
Source The Cleveland Clinic
Contact
Status Terminated
Phase Phase 4
Start date July 11, 2018
Completion date March 26, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT01627171 - Colonoscopy Preparation Optimization for INpatients- COIN Study Phase 4
Completed NCT03329339 - The Effect of 1L Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-Residue Diet for Bowel Preparation N/A
Not yet recruiting NCT04446195 - The Effect of Individualized Intervention on the Quality of Bowel Preparation N/A
Completed NCT03925506 - Predictive Factors of Inadequate Bowel Preparation in Inpatients
Recruiting NCT04474002 - Efficacy, Tolerance and Safety of Split Dose Bowel Preparation for Colonoscopy: 4L Polyethylene Glycol (PEG) Versus 1L Polyethylene Glycol Plus Sodium Picosulfate-magnesium Citrate (SPMC) Phase 4