Water Method in Elder Patients With Unsedated Colonoscopy

Not Applicable

Withdrawn

• Conditions: Adenoma; Pain
• Interventions: Other: Water colonoscopy

• Registration Number: NCT01546220
• Lead Sponsor: Air Force Military Medical University, China

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 Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-07
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-24
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients over the age of 70

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water colonoscopy	Water colonoscopy	Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.

Primary Outcome Measures

Name	Time	Method
Cecal intubation success rate	up to two years	Insertion of a colonoscope to the cecum

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Endoscopic center, Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China