Comparing Clinical Performance of Novice Trainee Endoscopists Using Conventional Air Insufflation Versus Warm Water Infusion Colonoscopy
Recruitment status was Recruiting
Hypothesis: Novice trainees will achieve significantly higher clinical competence and patient satisfaction scores with the use of warm water infusion method when compared with traditional air insufflation
Primary outcome: adenoma detection rate
Secondary outcomes: (1) independent cecal intubation rate, (2) trainer assessment of trainee's colonoscopy skills, (3) trainee's assessment of clinical confidence, (4) procedural medication requirement, (5) patient pain level during procedure, (6) patient satisfaction at procedure completion, and (7) patient willingness to repeat procedure'
Specific Aim: To demonstrate the stated hypothesis via above outcome measures. The long term goal is to provide evidence to influence other training institutions to consider education in the warm water infusion method'
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Randomized Cross-Over Comparing Clinical Performance of Novice Trainee Endoscopists Using Conventional Air Insufflation Versus Warm Water Infusion Colonoscopy|
- adenoma detection rate [ Time Frame: two years ] [ Designated as safety issue: No ]
- independent cecal intubation rate [ Time Frame: two years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Water Colonoscopy Method
As first described by Dr. Felix W. Leung, the maneuvers can be summarized as warm water infusion in lieu of air insufflation combined with suction removal of all residual colonic air and residual feces by water exchange. The air pump will be turned off before insertion of the colonoscope into the rectum to avoid accidental insufflation of air. Warm water (at 36-37ºC) maintained using a water bath and heat saver envelop will be infused intermittently. The minimum amount of water needed to distend the colon and open the lumen will be used during scope insertion. Cecal intubation will be suggested by appropriate movement of the endoscopic image on the monitor screen when the right lower quadrant is palpated or the appendiceal orifice visualized under water. The cecum will then be distended by air to confirm visualization of the ileocecal valve and appendiceal orifice. No specific limit will be set for the volume of water to be used.
Air Colonoscopy Method
The minimal amount of air will be used during insertion to open the lumen. Minimal amounts of water (10 to 50 mL) at room temperature will be used for washing of residual feces. If insertion is hindered by scope looping, attempts at loop reduction will be made. If advancement does not occur within 3 to 5 minutes, an assistant will provide abdominal compression, followed by changing the patient's position to facilitate passage of the colonoscope. Cecal intubation will be suggested by identification of the appendiceal orifice and ileocecal valve or intubation of the terminal ileum.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01482546
|Contact: Joseph W Leung, MDfirstname.lastname@example.org|
|United States, California|
|University of California Davis||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Joseph W Leung, MD 916-734-7183 email@example.com|
|Contact: Catherine Ngo, MD 9167347183 firstname.lastname@example.org|
|Principal Investigator: Joseph W Leung, MD|