N/A
N=219
Cap Assisted Colonoscopy Enhances Quality Based Competency in Colonoscopy Among Trainees
Endoscopy, Gastrointestinal
Bottom Line
View on ClinicalTrials.gov: NCT02472730 ↗Enrolled (actual)
219
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Number of Participants That Successfully Reached the Cecum Within 30 Minutes of Insertion — 80; 67 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Distal Attachment Cap (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Successfully Reached the Cecum Within 30 Minutes of Insertion |
80; 67 | — |
| SECONDARY Mean Time From the Moment of Colonoscope Insertion Until the Appendiceal Orifice or Ileocecal Valve is Identified |
13.7; 16.5 | — |
| SECONDARY Number of Colonoscopies During Which at Least One Adenoma Was Identified |
38; 44 | — |
| SECONDARY Number of Colonoscopies During Which at Least One Polyp Was Identified |
54; 55 | — |
Summary
The purpose of this study is to identify if performing diagnostic colonoscopy with a small plastic cap attached to the camera will improve performance of colonoscopies by physician trainees.
Eligibility Criteria
Inclusion Criteria
- All patients undergoing colonoscopy by a novice endoscopist
Exclusion Criteria
- Age less than 18 years or greater than 90 years.
- Pregnancy.
- Prior surgical resection of colon or rectum.
- Known obstructing colorectal tumors.
- Severe hematochezia.
- Diverticulitis within 1 month of procedure.
- Clinical or radiological evidence of colonic obstruction or megacolon within 1 month of procedure.
- Referral for endoscopic mucosal resection.
- Unsedated colonoscopies.
- Colonoscopies abandoned due to inadequate bowel prep or colonoscopies with Boston bowel prep score < 3.
Data sourced from ClinicalTrials.gov (NCT02472730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.