Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Comparing Clinical Performance of Novice Trainee Endoscopists Using Conventional Air Insufflation Versus Warm Water Infusion Colonoscopy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Catherine Ngo, University of California, Davis.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Catherine Ngo, University of California, Davis Identifier:
First received: November 27, 2011
Last updated: November 29, 2011
Last verified: November 2011

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'

Colonoscopy Education

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Catherine Ngo, University of California, Davis:

Primary Outcome Measures:
  • adenoma detection rate [ Time Frame: two years ]

Secondary Outcome Measures:
  • independent cecal intubation rate [ Time Frame: two years ]

Estimated Enrollment: 6
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.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
First Year Gastroenterology Trainees

Inclusion Criteria:

  • Novice endoscopists without prior colonoscopy experience

Exclusion Criteria:

  • Trainees who do not meet the basic prerequisites as stated above, or who are not willing to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01482546

Contact: Joseph W Leung, MD 9167347183

United States, California
University of California Davis Recruiting
Sacramento, California, United States, 95817
Contact: Joseph W Leung, MD    916-734-7183   
Contact: Catherine Ngo, MD    9167347183   
Principal Investigator: Joseph W Leung, MD         
Sponsors and Collaborators
University of California, Davis
  More Information

Responsible Party: Catherine Ngo, Clinical Fellow, University of California, Davis Identifier: NCT01482546     History of Changes
Other Study ID Numbers: 238499
Study First Received: November 27, 2011
Last Updated: November 29, 2011

Keywords provided by Catherine Ngo, University of California, Davis:
adenoma detection rate
cecal intubation rate processed this record on May 25, 2017