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Bowel Preparation for Inpatient Colonoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Santa Clara Valley Health & Hospital System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Santa Clara Valley Health & Hospital System
ClinicalTrials.gov Identifier:
NCT01169220
First received: July 20, 2010
Last updated: July 23, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Hemorrhage
Colon Cancer
Diverticulosis
 Drug: Go-Lytely
Drug: Go Lytely
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Diagnostic
Official Title: Single Blind, Randomized, Controlled Trial of Conventional Versus Split-Dose Bowel Preparation for Inpatient Colonoscopy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Santa Clara Valley Health & Hospital System:

Primary Outcome Measures:
  • Quality of colon cleansing [ Time Frame: 24 hours from study enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: 24 hours from study enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Split prep Drug: Go Lytely
Bowel cleansing agent
Active Comparator: Whole prep Drug: Go-Lytely
Bowel cleansing agent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169220

Locations
United States, California
Santa Clara Valley Medical Center Recruiting
San Jose, California, United States, 95128
Contact: Ahmad Kamal, MD MSc     408-885-5000        
Sponsors and Collaborators
Santa Clara Valley Health & Hospital System
  More Information

No publications provided

Responsible Party: Ahmad Kamal, Santa Clara Valley Medical Center
ClinicalTrials.gov Identifier: NCT01169220     History of Changes
Other Study ID Numbers: 10-041
Study First Received: July 20, 2010
Last Updated: July 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Santa Clara Valley Health & Hospital System:
Colonoscopy
Bowel preparation

Additional relevant MeSH terms:
Colonic Neoplasms
Diverticulum
Gastrointestinal Hemorrhage
Hemorrhage
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013