Bowel Preparation for Inpatient Colonoscopy

• Sponsor: Santa Clara Valley Health & Hospital System (Other)
• Overall Status: Completed
• CT.gov ID: NCT01169220
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arms: 2
• Duration (Months): 42.1
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Hemorrhage; Colon Cancer; Diverticulosis	Drug: Go-Lytely; Drug: Go Lytely	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Diagnostic
• Official Title: Single Blind, Randomized, Controlled Trial of Conventional Versus Split-Dose Bowel Preparation for Inpatient Colonoscopy
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Quality of colon cleansing [24 hours from study enrollment]

Secondary Outcome Measures

1. Patient satisfaction [24 hours from study enrollment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Santa Clara Valley Medical Center	San Jose	California	United States	95128

Sponsors and Collaborators

• Santa Clara Valley Health & Hospital System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Santa Clara Valley Health & Hospital System
• ClinicalTrials.gov Identifier: NCT01169220
• Other Study ID Numbers: 10-041
• First Posted: Jul 26, 2010
• Last Update Posted: Oct 5, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Santa Clara Valley Health & Hospital System: Colonoscopy; Bowel preparation
• Additional relevant MeSH terms: Gastrointestinal Hemorrhage; Diverticulum; Diverticular Diseases; Hemorrhage

Study Results

No Results Posted as of Oct 5, 2017