Randomized Controlled Trial Comparing Water vs. Air Method for Performing Colonoscopy in Adult Female Subjects
Completed · Not applicable
Conditions studied: Screening for Colon Cancer
In brief
This is a prospective , single center, investigator initiated, randomized controlled trial to compare two methods of performing colonoscopy by experienced colonoscopist. Potential female subjects presenting for colonoscopy at UCD GI Lab will be presented with the study option and will be enrolled if they sign the informed consent. In recent years, the water infusion method has been reported to have several beneficial effects when studied in veteran patients. These include: significant reduction in discomfort to permit a significantly higher percentage (98% vs. 76%) of veterans to complete scheduled unsedated colonoscopy, lower sedation medication requirement when they accepted the option of minimal pre-medication sedation, more patients completing without sedation (78% vs 54%) when they accepted the on demand sedation and an increase in the yield of adenomas (a type of cancer seen in the colon) in screening and surveillance colonoscopy. Reviewers of the method have repeatedly called for studies using the method in female patients to confirm or refute the findings as most of the veteran patients are male patients.
Key facts
- Study ID
- NCT01790425
- Run by
- University of California, Davis
- People needed
- 200
- Starts
- 2011-08-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2017-06-27
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- All female patients between the ages of 18 to 80 years scheduled for colonoscopy at UC Davis GI Lab.
You may not qualify if…
- Patients who refuse to be randomized to the air or water colonoscopy method.
- Patients who are unable to respond to study questionnaires.
- Patients with partial colon resection
Where it is running
- University of California, Davis — Sacramento, California, United States
Full record on ClinicalTrials.gov
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