Left-colon WEC May Reduce Insertion Time Compared With Whole-colon WEC.

Not Applicable

Completed

• Conditions: Polyp; Pain
• Interventions: Other: Air colonoscopy; Other: Water exchange colonoscopy

• Registration Number: NCT01735266
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

In most of situation, left colon (especially SD junction) is considered the most difficult part of colonoscopy, where endoscopist may encounter difficulty for scope insertion and patients may feel pain or uncomfortable. It is suggested more than half of the whole time for scope insertion should be used in left colon. Many methods, such as water immersion, abdominal palpation, have been used to facilitate insertion in left colon.

Colonoscopy with whole-colon water exchange method has been shown to be useful for reducing medication used, pain experienced during colonoscopy, increasing the success rate of cecum intubation and adenoma detection rate in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes loop formation and prevents lengthening and distension of the colon during colonoscopy. This will facilitate the colonoscopy in average or difficult colonoscopy. However, it is not known whether the benefits of water exchange method of colonoscopy was mainly due to its effect on the left colon.

We hypothesized that left-colon water exchange colonoscopy (LWE) may have the similar effect regarding the maximal pain score and mean pain score in unsedated patients compared with whole-colon water exchange colonoscopy (WWE). At the mean time, LWE may reduce the insertion time compared with WWE. Here we performed a prospective, randomized controlled study to investigate the efficacies of whole-colon water exchange, left-colon water exchange and air methods of colonoscopy on pain score and insertion time in unsedated outpatients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-23
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-28
• Study Start: 2013-05
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-11
• Last Update Posted: 2013-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Outpatients with unsedated colonoscopy

Exclusion Criteria

• history of colon resection
• severe colonic stricture or obstructing tumor
• hemodynamic instability
• current pregnancy
• inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Air colonoscopy	Air colonoscopy	Air was insufflated during whole procedure of colonoscope insertion.
Whole-colon water exchange colonoscopy	Water exchange colonoscopy	The air pump was turned off before colonoscopy. During the whole procedure of the scope insertion, residual air in lumen was suctioned and 37°C (maintained with a water bath) water was infused with a peristaltic pump to obtain lumen visualization. Air was insufflated until cecum was reached or appendix opening was seen.
left-colon water exchange colonoscopy	Water exchange colonoscopy	In the left side of colon (including descending colon, sigmoid colon and rectum), water was infused instead of air to obtain lumen visualization as described above in whole-colon water exchange colonoscopy group.

Primary Outcome Measures

Name	Time	Method
Cecum intubation time	up to three months	Insertion time from rectum to reach the cecum.

Secondary Outcome Measures

Name	Time	Method
Pain scores	up to two months	Pain scores include mean pain score and maximal pain score.; Mean pain score: mean value of patient reported pain score during the insertion phase in three part of colon by using the visual analog pain scale (0=no pain and 10=most severe pain imaginable).; Maximal pain score: maximal value of patient reported pain score during the insertion phase in three part of colon by using the visual analog pain scale (0=no pain and 10=most severe pain imaginable).
Polyp detection rate	up to six months	The proportion of subjects with at least one polyp.
Total procedure time	up to two months	Total time of colonoscopic procedure.
Cecal intubation rate	up to two months	Percentage of successful colonoscopy (insertion of colonoscope into cecum).
Withdrawal time	up to two month	Withdrawal time is defined as the time from withdrawal of the colonoscope from the cecum to anal verge. (This time is measured independent of any therapeutic maneuvers, such as biopsy or polypectomy.)
Patients willingness to repeat colonoscopy using same method	up to two month	When after the colonoscopic examination, patients were asked if they have willingness to repeat the colonoscopy using same method.
Procedure difficulty evaluated by endoscopist	up to two month	When after the colonoscopy, endoscopist were asked to score on the difficulty of the colonoscopic procedure.; 0-very easy, 10-very difficult

Trial Locations

Locations (1)

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