Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

March 20, 2017 updated by: Roy Soetikno, VA Palo Alto Health Care System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

229

Phase

  • Not Applicable

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
      • Palo Alto, California, United States, 94304
        • VA Palo Alto Health Care System

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

Male

Description

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

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: Water Immersion Colonoscopy
Procedure: water immersion colonoscopy
instillation of 300cc of water in the rectum
Active Comparator: Standard Air Colonoscopy
Procedure: standard air colonoscopy
air instillation in colon for visualization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Colonoscopy Success With Minimal Sedation
Time Frame: At the time of the procedure
At the time of the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Cecum
Time Frame: At the time of the procedure
At the time of the procedure
Patient Satisfaction
Time Frame: At the time of the procedure
Patient satisfaction was measured on a scale of 1 (best) to 7 (worst).
At the time of the procedure

Collaborators and Investigators

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

Sponsor

VA Palo Alto Health Care System

Investigators

  • Principal Investigator: Roy Soetikno, MD, MS, VA Palo Alto/Stanford University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 1, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (Estimate)

May 5, 2008

Study Record Updates

Last Update Posted (Actual)

May 1, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol10642

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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