Back to resultsBowel Preparation for Inpatient Colonoscopy
Primary Purpose
Gastrointestinal Hemorrhage, Colon Cancer, Diverticulosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Go-Lytely
Go Lytely
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Hemorrhage focused on measuring Colonoscopy, Bowel preparation
Eligibility Criteria
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
Sites / Locations
- Santa Clara Valley Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Split prep
Whole prep
Arm Description
Outcomes
Primary Outcome Measures
Quality of colon cleansing
Secondary Outcome Measures
Patient satisfaction
Full Information
NCT ID
NCT01169220
First Posted
July 20, 2010
Last Updated
October 3, 2017
Sponsor
Santa Clara Valley Health & Hospital System
1. Study Identification
Unique Protocol Identification Number
NCT01169220
Brief Title
Bowel Preparation for Inpatient Colonoscopy
Official Title
Single Blind, Randomized, Controlled Trial of Conventional Versus Split-Dose Bowel Preparation for Inpatient Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santa Clara Valley Health & Hospital System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage, Colon Cancer, Diverticulosis
Keywords
Colonoscopy, Bowel preparation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Split prep
Arm Type
Experimental
Arm Title
Whole prep
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Go-Lytely
Intervention Description
Bowel cleansing agent
Intervention Type
Drug
Intervention Name(s)
Go Lytely
Intervention Description
Bowel cleansing agent
Primary Outcome Measure Information:
Title
Quality of colon cleansing
Time Frame
24 hours from study enrollment
Secondary Outcome Measure Information:
Title
Patient satisfaction
Time Frame
24 hours from study enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Santa Clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
12. IPD Sharing Statement
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Bowel Preparation for Inpatient Colonoscopy
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