Bowel Preparation for Inpatient Colonoscopy

October 3, 2017 updated by: Santa Clara Valley Health & Hospital System

Single Blind, Randomized, Controlled Trial of Conventional Versus Split-Dose Bowel Preparation for Inpatient Colonoscopy

This study will compare two strategies for bowel cleansing prior to inpatient colonoscopy: the entire preparation taken the night before the procedure versus half the preparation taken the night before the procedure, and the other half taken the morning of the procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95128
        • Santa Clara Valley Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • any diagnosis for which colonoscopy is indicated

Exclusion Criteria:

  • ileus
  • severe colitis/toxic megacolon
  • gastric retention
  • bowel perforation
  • gastrointestinal obstruction
  • gastroparesis that precludes oral bowel preparation
  • pregnant or lactating women
  • allergy to polyethylene glycol.
  • unable to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Split prep
Drug: Go Lytely
Bowel cleansing agent
Active Comparator: Whole prep
Drug: Go-Lytely
Bowel cleansing agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of colon cleansing
Time Frame: 24 hours from study enrollment
24 hours from study enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction
Time Frame: 24 hours from study enrollment
24 hours from study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santa Clara Valley Health & Hospital System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 20, 2010

First Submitted That Met QC Criteria

July 23, 2010

First Posted (Estimate)

July 26, 2010

Study Record Updates

Last Update Posted (Actual)

October 5, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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