We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00671177
First Posted: May 5, 2008
Last Update Posted: May 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roy Soetikno, VA Palo Alto Health Care System
  Purpose
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.

Condition Intervention
Colonoscopy Digestive System Endoscopy Gastrointestinal Disease Procedure: water immersion colonoscopy Procedure: standard air colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique

Resource links provided by NLM:


Further study details as provided by Roy Soetikno, VA Palo Alto Health Care System:

Primary Outcome Measures:
  • Colonoscopy Success With Minimal Sedation [ Time Frame: At the time of the procedure ]

Secondary Outcome Measures:
  • Time to Cecum [ Time Frame: 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).


Enrollment: 229
Study Start Date: September 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Water Immersion Colonoscopy
Water Immersion Colonoscopy
Procedure: water immersion colonoscopy
instillation of 300cc of water in the rectum
Active Comparator: Standard Air Colonoscopy
Standard Air Colonoscopy
Procedure: standard air colonoscopy
air instillation in colon for visualization

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671177


Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
VA Palo Alto Health Care System
Investigators
Principal Investigator: Roy Soetikno, MD, MS VA Palo Alto/Stanford University Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roy Soetikno, Clinical Professor, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT00671177     History of Changes
Other Study ID Numbers: Protocol10642
First Submitted: May 1, 2008
First Posted: May 5, 2008
Results First Submitted: January 17, 2017
Results First Posted: May 1, 2017
Last Update Posted: May 1, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Roy Soetikno, VA Palo Alto Health Care System:
colonoscopy
diagnostic techniques
digestive system
endoscopy
gastrointestinal

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases