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

Usefulness of Cap-assisted Colonoscopy in Patients With Prior Abdominal Surgery: A Randomized, Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Insertion Time
• Intervention / Treatment: Device: cap-assisted colonoscopy; Device: Standard colonoscopy

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 Type: Interventional
• Enrollment (Anticipated): 1046
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with history of abdominal or pelvic surgery

Exclusion Criteria:

• Previous colorectal resection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cap-assisted colonoscopy; cap-assisted colonoscopy	Device: cap-assisted colonoscopy; cap-assisted colonoscopy
ACTIVE_COMPARATOR: Standard colonoscopy	Device: Standard colonoscopy; Standard colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Insertion time	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient discomfort	10-point visual analog scale	Day 1
Overall technical ease	10-point visual analog scale	Day 1

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: February 1, 2017
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (ESTIMATE): January 11, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO