Clinical Trial: Water Method Colonoscopy in Patients With Prior Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Water Colonoscopy Versus Air Colonoscopy for Unsedated Patients With Prior Abdominal or Pelvic Surgery: 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.

Prior abdominal or pelvic surgery is an independent factor for difficult colonoscopy, the probable adhesion may change the anatomy and increase the discomfort of patients. We postulate that these patients may benefit from using the water method for colonoscopy. In this proposal we test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in patients with prior abdominal or pelvic surgery.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in patients with prior abdominal or pelvic surgery. 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 ten months ]

Insertion of a colonoscope to the cecum


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

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Adenoma detection rate [ Time Frame: up to two years ]
  • Pain Scores on the Visual Analog Scale [ Time Frame: up to two years ]
  • Total time of colonoscope intubation from anus to cecum [ Time Frame: up to two years ]


Information By: Fourth Military Medical University

Dates:
Date Received: November 30, 2011
Date Started: November 2011
Date Completion:
Last Updated: November 6, 2012
Last Verified: November 2012