Clinical Trial: Water Method in Elder Patients With Unsedated Colonoscopy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Water Method With Water Exchange Versus Air Insufflation in Elder Patients Undergoing Unsedated Colonoscopy: a Prospective Randomized, Controlled Trial

Brief Summary:

Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy.

Older age is independently associated with incomplete colonoscopy, the investigators postulate that these patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in elder patients.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in elder patients. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.


Detailed Summary:
Sponsor: Fourth Military Medical University

Current Primary Outcome: Cecal intubation success rate [ Time Frame: up to two years ]

Insertion of a colonoscope to the cecum


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adenoma detection rate [ Time Frame: up to two years ]
    The proportion of participants with at least one adenoma in each group
  • Pain Scores on the Visual Analog Scale [ Time Frame: up to two years ]
    0 = no pain, to 10 = most severe pain
  • Cecum intubation time [ Time Frame: up to two years ]
    Total time of colonoscope intubation from anus to cecum


Original Secondary Outcome: Same as current

Information By: Fourth Military Medical University

Dates:
Date Received: February 24, 2012
Date Started: November 2011
Date Completion: December 2014
Last Updated: March 24, 2016
Last Verified: March 2016