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Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

Primary Purpose

Colonoscopy, Digestive System, Endoscopy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
water immersion colonoscopy
standard air colonoscopy
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonoscopy focused on measuring colonoscopy, diagnostic techniques, digestive system, endoscopy, gastrointestinal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • presentation for colonoscopy
  • male
  • age 18 or older

Exclusion Criteria:

  • women
  • known inflammatory bowel disease
  • presentation for emergency colonoscopy
  • history of partial colectomy
  • chronic narcotic or benzodiazepine use

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Water Immersion Colonoscopy

Standard Air Colonoscopy

Arm Description

Water Immersion Colonoscopy

Standard Air Colonoscopy

Outcomes

Primary Outcome Measures

Colonoscopy Success With Minimal Sedation

Secondary Outcome Measures

Time to Cecum
Patient Satisfaction
Patient satisfaction was measured on a scale of 1 (best) to 7 (worst).

Full Information

First Posted
May 1, 2008
Last Updated
March 20, 2017
Sponsor
VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT00671177
Brief Title
Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique
Official Title
Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Recent studies indicate that infusing 300 milliliters of water (in lieu of air) into the rectum and left colon through the colonoscope as it is being inserted during a colonoscopy examination can allow easier endoscope advancement. This method may prevent stretching of the colon, and ultimately reduce pain induced during colonoscopy. Improvements in patient comfort and cooperation, may increase the efficiency and success rate of complete colonoscopy. The purpose of the study is to test the efficacy of the water immersion technique in patients colonoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Digestive System, Endoscopy, Gastrointestinal Disease
Keywords
colonoscopy, diagnostic techniques, digestive system, endoscopy, gastrointestinal

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water Immersion Colonoscopy
Arm Type
Experimental
Arm Description
Water Immersion Colonoscopy
Arm Title
Standard Air Colonoscopy
Arm Type
Active Comparator
Arm Description
Standard Air Colonoscopy
Intervention Type
Procedure
Intervention Name(s)
water immersion colonoscopy
Intervention Description
instillation of 300cc of water in the rectum
Intervention Type
Procedure
Intervention Name(s)
standard air colonoscopy
Intervention Description
air instillation in colon for visualization
Primary Outcome Measure Information:
Title
Colonoscopy Success With Minimal Sedation
Time Frame
At the time of the procedure
Secondary Outcome Measure Information:
Title
Time to Cecum
Time Frame
At the time of the procedure
Title
Patient Satisfaction
Description
Patient satisfaction was measured on a scale of 1 (best) to 7 (worst).
Time Frame
At the time of the procedure

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: presentation for colonoscopy male age 18 or older Exclusion Criteria: women known inflammatory bowel disease presentation for emergency colonoscopy history of partial colectomy chronic narcotic or benzodiazepine use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Soetikno, MD, MS
Organizational Affiliation
VA Palo Alto/Stanford University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20593332
Citation
Leung CW, Kaltenbach T, Soetikno R, Wu KK, Leung FW, Friedland S. Water immersion versus standard colonoscopy insertion technique: randomized trial shows promise for minimal sedation. Endoscopy. 2010 Jul;42(7):557-63. doi: 10.1055/s-0029-1244231. Epub 2010 Jun 30.
Results Reference
derived

Learn more about this trial

Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

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