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

Pain Clinical Trial

Official title:

Comparative Efficacy of Whole-colon Water Exchange, Left-colon Water Exchange and Air Methods of Colonoscopy on Cecum Intubation in Unsedated Outpatients - - - a Prospective, Randomized Controlled Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735266
• Other study ID #: 20121108-5
• Status: Completed
• Phase: N/A
• First received: November 23, 2012
• Last updated: September 11, 2013
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Pain
• Polyp

Intervention

Other:
• Air colonoscopy
Colonoscopy will be performed with conventional air insufflation during colonoscope insertion.
• Water exchange colonoscopy
Water exchange method (The air pump was turned off before colonoscopy. During colonoscope insertion, residual air in lumen was suctioned and 37°C water was infused into lumen to obtain lumen visualization) was used in whole or left colon. Air was insufflated until cecum was reached or appendix opening was seen.

Locations

Country	Name	City	State
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cecum intubation time	Insertion time from rectum to reach the cecum.	up to three months	No
Secondary	Pain scores	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).	up to two months	No
Secondary	Polyp detection rate	The proportion of subjects with at least one polyp.	up to six months	No
Secondary	Total procedure time	Total time of colonoscopic procedure.	up to two months	No
Secondary	Cecal intubation rate	Percentage of successful colonoscopy (insertion of colonoscope into cecum).	up to two months	No
Secondary	Withdrawal time	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.)	up to two month	No
Secondary	Patients willingness to repeat colonoscopy using same method	When after the colonoscopic examination, patients were asked if they have willingness to repeat the colonoscopy using same method.	up to two month	No
Secondary	Procedure difficulty evaluated by endoscopist	When after the colonoscopy, endoscopist were asked to score on the difficulty of the colonoscopic procedure.; 0-very easy, 10-very difficult	up to two month	No