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Clinical Trials/NCT01485133
NCT01485133
Completed
Not Applicable

Water Colonoscopy Versus Air Colonoscopy for Unsedated Patients With Prior Abdominal or Pelvic Surgery: a Prospective Randomized, Controlled Trial

Air Force Military Medical University, China1 site in 1 country110 target enrollmentNovember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation
Sponsor
Air Force Military Medical University, China
Enrollment
110
Locations
1
Primary Endpoint
Cecal intubation success rate
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
November 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Air Force Military Medical University, China
Responsible Party
Principal Investigator
Principal Investigator

Yanglin Pan

Associated professor

Air Force Military Medical University, China

Eligibility Criteria

Inclusion Criteria

  • Patients with prior abdominal or pelvic surgery,

Exclusion Criteria

  • History of colorectal surgery
  • Severe colonic stricture or obstructing tumor
  • Patients who cannot give informed consent and those who are hemodynamically unstable

Outcomes

Primary Outcomes

Cecal intubation success rate

Time Frame: up to ten months

Insertion of a colonoscope to the cecum

Secondary Outcomes

  • Adenoma detection rate(up to ten months)
  • Pain Scores on the Visual Analog Scale(up to ten months)
  • Cecum intubation time(up to ten months)

Study Sites (1)

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