An observational study in Intubation, Surgery and Adenoma, sponsored by Air Force Military Medical University, China. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-11-07.
Sponsored by Air Force Military Medical University, China · Observational
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.
662 studies on the registry are indexed under Adenoma; 101 are open to participants now.
This study's enrollment of 110 is below the median of 300 across 230 observational studies indexed under Adenoma.
Browse Adenoma studies →Air Force Military Medical University, China is the lead sponsor of 178 studies on the registry; 37 are open to participants now.
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Patients with prior abdominal or pelvic surgery undergoing unsedated colonoscopy will be recruited in this study.
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Exclusion Criteria:
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
Insertion of a colonoscope to the cecum
Time frame: up to ten months
Adenoma detection rate
The proportion of participants with at least one adenoma in each group
Time frame: up to ten months
Pain Scores on the Visual Analog Scale
0 = no pain, to 10 = most severe pain
Time frame: up to ten months
Cecum intubation time
Total time of colonoscope intubation from anus to cecum
Time frame: up to ten months
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Air Force Military Medical University, China →