Water Method Colonoscopy in Patients With Prior Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01485133|
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : November 7, 2012
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.
Prior abdominal or pelvic surgery is an independent factor for difficult colonoscopy, the probable adhesion may change the anatomy and increase the discomfort of patients. We postulate that these patients may benefit from using the water method for colonoscopy. In this proposal we test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in patients with prior abdominal or pelvic surgery.
The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in patients with prior abdominal or pelvic surgery. 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.
|Condition or disease|
|Intubation Surgery Adenoma Pain|
|Study Type :||Observational|
|Actual Enrollment :||110 participants|
|Observational Model:||Case Control|
|Official Title:||Water Colonoscopy Versus Air Colonoscopy for Unsedated Patients With Prior Abdominal or Pelvic Surgery: a Prospective Randomized, Controlled Trial|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||November 2012|
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. 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 via a needle adaptor or the built-in 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.
- Cecal intubation success rate [ Time Frame: up to ten months ]Insertion of a colonoscope to the cecum
- Adenoma detection rate [ Time Frame: up to ten months ]The proportion of participants with at least one adenoma in each group
- Pain Scores on the Visual Analog Scale [ Time Frame: up to ten months ]0 = no pain, to 10 = most severe pain
- Cecum intubation time [ Time Frame: up to ten months ]Total time of colonoscope intubation from anus to cecum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485133
|Endoscopic center, Xijing Hospital of Digestive Diseases|
|Xi'an, Shaanxi, China, 710032|
|Principal Investigator:||Yanglin Pan, MD||Fourth Military Medical University|