The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

Not Applicable

Terminated

• Conditions: Adenoma
• Interventions: Device: Conventional colonoscopy; Device: Cap Assisted Colonoscopy

• Registration Number: NCT01601431
• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

Brief Summary

This is a research study about the usefulness of transparent cap during screening colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will improve the detection of adenomatous polyps (polyps which can become colon cancer later on) in comparison to the standard colonoscopy.

Detailed Description

This is a prospective, randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy. The aims of the study are:

1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.

2. Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.

3. Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.

4. Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.

Study Timeline

• Study Start: 2012-03-29
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-18
• Primary Completion: 2015-02-02
• Study Completion: 2015-02-02
• Results First Submitted: 2017-05-15
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-10
• Last Update Submitted: 2018-05-10
• Results First Posted: 2018-06-07
• Last Update Posted: 2018-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

• Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.

Exclusion Criteria

1. Patients younger than 18 yrs old or older than 80 yrs.
2. Patients with a prior history of colonic surgeries
3. Patient with Crohns colitis or ulcerative colitis.
4. Patient with prior history of colon cancer
5. Patient with poor bowel preparation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional colonoscopy	Conventional colonoscopy	A conventional colonoscopy does not use a Cap in order to perform the procedure
Cap Assisted Colonoscopy	Cap Assisted Colonoscopy	Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds.

Primary Outcome Measures

Name	Time	Method
ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.	1 year	1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center at El Paso; 🇺🇸 El Paso, Texas, United States