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

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ClinicalTrials.gov Identifier: NCT03016962
Recruitment Status : Not yet recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Jeong-Seon Ji, 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.

Condition or disease Intervention/treatment Phase
Insertion Time Device: cap-assisted colonoscopy Device: Standard colonoscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1046 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Usefulness of Cap-assisted Colonoscopy in Patients With Prior Abdominal Surgery: A Randomized, Controlled Trial
Study Start Date : February 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Cap-assisted colonoscopy
cap-assisted colonoscopy
Device: cap-assisted colonoscopy
cap-assisted colonoscopy

Active Comparator: Standard colonoscopy
Standard colonoscopy
Device: Standard colonoscopy
Standard colonoscopy




Primary Outcome Measures :
  1. Insertion time [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Patient discomfort [ Time Frame: Day 1 ]
    10-point visual analog scale

  2. Overall technical ease [ Time Frame: Day 1 ]
    10-point visual analog scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with history of abdominal or pelvic surgery

Exclusion Criteria:

  • Previous colorectal resection
Layout table for additonal information
Responsible Party: Jeong-Seon Ji, Dr, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03016962    
Other Study ID Numbers: Cap
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No