The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

Texas Tech University Health Sciences Center, El Paso

Status: Terminated

Conditions: Adenoma

Treatments: Device: Cap Assisted Colonoscopy; Device: Conventional colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01601431

E12050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

Cap Assisted Colonoscopy

Experimental group

Description:

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.

Treatment:

Device: Cap Assisted Colonoscopy

Conventional colonoscopy

Active Comparator group

Description:

A conventional colonoscopy does not use a Cap in order to perform the procedure

Treatment:

Device: Conventional colonoscopy