Usefulness of Cap-assisted Colonoscopy in Patients With Prior Abdominal Surgery

Not Applicable

• Conditions: Insertion Time
• Interventions: Device: Standard colonoscopy; Device: cap-assisted colonoscopy

• Registration Number: NCT03016962
• Lead Sponsor: The Catholic University of Korea

Brief Summary

The potential benefit of using the cap is that it helps in luminal orientation at bends by keeping the colonic mucosa away from the lens at the colonoscope tip. Colonoscopy in patients with a history of abdominal surgery is considered to be difficult due to adhesion-related bowel angulations. There were few study evaluating usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery. The investigators designed a randomized, controlled trial to verify the usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery.

Detailed Description

The potential benefit of using the cap is that it helps in luminal orientation at bends by keeping the colonic mucosa away from the lens at the colonoscope tip. This assists in negotiating sharp turns by better anticipation of the direction. Cap-assisted colonoscopy can be tried as a salvage procedure in cases of failed cecal intubation with regular colonoscopy. Colonoscopy in patients with a history of abdominal surgery is considered to be difficult due to adhesion-related bowel angulations. There were few study evaluating usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery. The investigators designed a randomized, controlled trial to verify the usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery.

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-09
• Last Update Submitted: 2017-01-09
• Study First Posted: 2017-01-11
• Last Update Posted: 2017-01-11
• Study Start: 2017-02
• Primary Completion: 2020-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1046

Inclusion Criteria

• Patients with history of abdominal or pelvic surgery

Exclusion Criteria

• Previous colorectal resection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard colonoscopy	Standard colonoscopy	Standard colonoscopy
Cap-assisted colonoscopy	cap-assisted colonoscopy	cap-assisted colonoscopy

Primary Outcome Measures

Name	Time	Method
Insertion time	Day 1

Secondary Outcome Measures

Name	Time	Method
Patient discomfort	Day 1	10-point visual analog scale
Overall technical ease	Day 1	10-point visual analog scale