Clinical trial NCT01735266: Left-colon WEC May Reduce Insertion Time Compared With Whole-colon WEC.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyp
Pain
Keywords: Colonoscopy
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cecum intubation time
timeFrame: up to three months
Secondary outcomes:
measure: Pain scores
timeFrame: up to two months
measure: Polyp detection rate
timeFrame: up to six months
measure: Total procedure time
timeFrame: up to two months
measure: Cecal intubation rate
timeFrame: up to two months
measure: Withdrawal time
timeFrame: up to two month
measure: Patients willingness to repeat colonoscopy using same method
timeFrame: up to two month
measure: Procedure difficulty evaluated by endoscopist
timeFrame: up to two month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Yanglin Pan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.