Water Method in Low-body Mass Index (BMI) Female Patients With Unsedated Colonoscopy
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.
Female gender and low-body mass index (BMI) is independently associated with incomplete colonoscopy, respectively. The investigators postulate that low-BMI female 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 low-BMI female patients.
The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in low-BMI female 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
|Official Title:||Water Method With Water Exchange Versus Air Insufflation in Low-BMI Female Patients Undergoing Unsedated Colonoscopy: a Prospective Randomized, Controlled Trial|
- Cecal intubation success rate [ Time Frame: up to two years ] [ Designated as safety issue: No ]Insertion of a colonoscope to the cecum
- Adenoma detection rate [ Time Frame: up to two years ] [ Designated as safety issue: No ]The proportion of participants with at least one adenoma in each group
- Pain Scores on the Visual Analog Scale [ Time Frame: up to two years ] [ Designated as safety issue: No ]0 = no pain, to 10 = most severe pain
- Cecum intubation time [ Time Frame: up to two years ] [ Designated as safety issue: No ]Total time of colonoscope intubation from anus to cecum
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
No Intervention: Air colonoscopy
Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.
Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.
Other: Water colonoscopy
Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecum) is reached. The water is delivered through scope irrigation channel by an infusion pump equipped with a foot switch which will be controlled by the endoscopist. Infused water used to cleanse residual fecal matter will be suctioned as needed to clear the colonic lumen.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546259
|Endoscopic center, Xijing Hospital of Digestive Diseases|
|Xi'an, Shaanxi, China, 710032|
|Principal Investigator:||Yanglin Pan, MD||Fourth Military Medical University|