A Comparison of Air Insufflation, Water Immersion and Water Exchange Colonoscopy in Diagnostic Patients

Completed · Not applicable

Conditions studied: Pain, Colorectal Adenomas, Colorectal Cancer

In brief

Water-aided method for colonoscopy can be broadly subdivided into two major categories. Water Immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy. Several studies showed that WE significantly reduces pain compared to WI and colonoscopy with traditional air insufflation (AI), increases the number of unsedated procedures and adenoma detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the hypothesis that WAC (particularly WE) would significantly decrease pain score during colonoscopy in diagnostic patients. Several other secondary outcomes will also be analyzed.

Key facts

Study ID

NCT01781650

Run by

Presidio Ospedaliero Santa Barbara

People needed

288

Starts

2013-03-01

Expected to finish

2013-09-01

Last updated by the study team

2014-01-15

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Consecutive 18 to 85 year-old first time diagnostic in-patients and outpatients agreeing to start procedure without premedication.

You may not qualify if…

• patient unwillingness to start the procedure without sedation/analgesia
• previous colorectal surgery
• indication for a proctosigmoidoscopy or bidirectional endoscopy
• patient refusal or inability to provide informed consent
• inadequate bowel preparation (patients unable to swallow at least ¾ of cleansing preparation, or that did have late and insufficient evacuations, or that reported the presence of residual stools in the last evacuations).

Where it is running

• Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• S. Barbara Hospital — Iglesias, CA, Italy
• N. S. di Bonaria Hospital — San Gavino Monreale, VS, Italy

Full record on ClinicalTrials.gov

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