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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Polyp
• Intervention / Treatment: Other: Air colonoscopy; Other: Water exchange colonoscopy

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Endoscopic center, Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Air colonoscopy; Air was insufflated during whole procedure of colonoscope insertion.	Other: Air colonoscopy; Colonoscopy will be performed with conventional air insufflation during colonoscope insertion.
Experimental: Whole-colon 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.	Other: 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.; Other Names: Water aided colonoscopy
Experimental: left-colon 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.	Other: 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.; Other Names: Water aided colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cecum intubation time	Insertion time from rectum to reach the cecum.	up to three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Polyp detection rate	The proportion of subjects with at least one polyp.	up to six months
Total procedure time	Total time of colonoscopic procedure.	up to two months
Cecal intubation rate	Percentage of successful colonoscopy (insertion of colonoscope into cecum).	up to two months
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
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
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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: Yanglin Pan, M.D., Air Force Military Medical University, China

Publications and helpful links

General Publications

• Wang X, Luo H, Xiang Y, Leung FW, Wang L, Zhang L, Liu Z, Wu K, Fan D, Pan Y, Guo X. Left-colon water exchange preserves the benefits of whole colon water exchange at reduced cecal intubation time conferring significant advantage in diagnostic colonoscopy - a prospective, randomized controlled trial. Scand J Gastroenterol. 2015 Jul;50(7):916-23. doi: 10.3109/00365521.2015.1010569. Epub 2015 Feb 1.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: November 23, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (Estimate): November 28, 2012

Study Record Updates

• Last Update Posted (Estimate): September 12, 2013
• Last Update Submitted That Met QC Criteria: September 11, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Colonoscopy
• Other Study ID Numbers: 20121108-5