Randomized Controlled Trial Comparing Water vs. Air Method for Performing Colonoscopy in Adult Female Subjects
Study Aim Our aim is to perform a randomized controlled trial comparing air insufflation
colonoscopy (conventional method ) vs. water infusion colonoscopy ( study method ) in non
veteran female subjects presenting for colonoscopy . Subjects will be randomized 1:1 like
the flip of coin.
Study Design This is a prospective, single center, investigator initiated, randomized
controlled trial (RCT) to compare the study method (water infusion colonoscopy) with
conventional method (air insufflation colonoscopy "pump air to dilate the colon to visualize
the colon mucosa) in female patients by experienced colonoscopist. Patients will be
classified ASA 1 (No organic, physiologic, biomedical or psychiatric disturbance) and ASA 2
(Mild to moderate systemic diseases which are well controlled including hypertension,
diabetes mellitus, asthma, age 70 and over) before colonoscopy procedure.
Research Methods and Procedures The air (conventional) method: Air is pumped gently
(insufflation) into the colon will be used to open the inside space of the colon and aid in
colonoscope insertion The water (study) method: Warm water (body temperature) will be pumped
into the colon in place of air to open the inside of space of the colon and aid in
colonoscope insertion After insertion, both methods may use any of the following procedures
to advance the colonoscope in to the colon: colonoscope shortening maneuver, abdominal
compression, by the assistant, and change of patient position. In both methods air
insufflation will be used to distend the colon for inspection, biopsy and polypectomy.
Washing of the stool covered mucosa and inspection behind the folds will be performed
systematically. After turn around in the rectum, residual air and water will be removed by
Data gathering instruments used in the VA studies will be employed (subject interview
questions are attached). Statistical analyses similar to those used in the previous VA
studies (Student's t tests, Fischer's exact test, Mann-Whitney U test, etc) will be used to
analyze the data.
Biopsy and polypectomy will be performed as usual and all tissues will be submitted for
routine histological assessment and the pathology will be recorded.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Examination of the cecum by endoscopy
Surinder Mann, M.D.
United States: Institutional Review Board
UCD IRB # 319719
|University of California, Davis||Sacramento, California 95818|