Comparing Clinical Performance of Novice Trainee Endoscopists Using Conventional Air Insufflation Versus Warm Water Infusion Colonoscopy
This study is currently recruiting participants.
Verified November 2011 by University of California, Davis
Sponsor:
University of California, Davis
Information provided by (Responsible Party):
Catherine Ngo, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01482546
First received: November 27, 2011
Last updated: November 29, 2011
Last verified: November 2011
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Purpose
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'
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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 University of California, Davis:
Primary Outcome Measures:
- adenoma detection rate [ Time Frame: two years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- independent cecal intubation rate [ Time Frame: two years ] [ Designated as safety issue: No ]
| 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) |
| Groups/Cohorts |
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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.
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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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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
First Year Gastroenterology Trainees
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482546
Contacts
| Contact: Joseph W Leung, MD | 9167347183 | joseph.leung@ucdmc.ucdavis.edu |
Locations
| United States, California | |
| University of California Davis | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Joseph W Leung, MD 916-734-7183 joseph.leung@ucdmc.ucdavis.edu | |
| Contact: Catherine Ngo, MD 9167347183 catherine.ngo@ucdmc.ucdavis.edu | |
| Principal Investigator: Joseph W Leung, MD | |
Sponsors and Collaborators
University of California, Davis
More Information
No publications provided
| Responsible Party: | Catherine Ngo, Clinical Fellow, University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT01482546 History of Changes |
| Other Study ID Numbers: | 238499 |
| Study First Received: | November 27, 2011 |
| Last Updated: | November 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Davis:
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colonoscopy trainees water adenoma detection rate cecal intubation rate |
ClinicalTrials.gov processed this record on June 13, 2013