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

NCT01482546 | Completed DMC

• 1 other identifier: 238499
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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'

Conditions

Colonoscopy Education

Keywords

colonoscopy; trainees; water; adenoma detection rate; cecal intubation rate

Outcome Measures

Primary Outcomes (1)

• adenoma detection rate

  two years

Secondary Outcomes (1)

• independent cecal intubation rate

  two years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

First Year Gastroenterology Trainees

You may qualify if:

• Novice endoscopists without prior colonoscopy experience

You may not qualify if:

• Trainees who do not meet the basic prerequisites as stated above, or who are not willing to participate in the study

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2011
• First Posted: November 30, 2011
• Study Start: May 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

US (1)