Skip to main content
Clinical Trials/NCT01546259
NCT01546259
Withdrawn
Not Applicable

Water Method With Water Exchange Versus Air Insufflation in Low-BMI Female Patients Undergoing Unsedated Colonoscopy: a Prospective Randomized, Controlled Trial

Air Force Military Medical University, China1 site in 1 countryNovember 2011
ConditionsAdenomaPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adenoma
Sponsor
Air Force Military Medical University, China
Locations
1
Primary Endpoint
Cecal intubation success rate
Status
Withdrawn
Last Updated
10 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.

Female gender and low-body mass index (BMI) is independently associated with incomplete colonoscopy, respectively. The investigators postulate that low-BMI female 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 low-BMI female patients.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in low-BMI female 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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

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

  • Female patients with BMI \< 20

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 two years

Insertion of a colonoscope to the cecum

Secondary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials