- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03016962
Usefulness of Cap-assisted Colonoscopy in Patients With Prior Abdominal Surgery
January 9, 2017 updated by: Jeong-Seon Ji, The Catholic University of Korea
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
Intervention / Treatment
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cap-assisted colonoscopy
cap-assisted colonoscopy
|
cap-assisted colonoscopy
|
ACTIVE_COMPARATOR: Standard colonoscopy
|
Standard colonoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insertion time
Time Frame: Day 1
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient discomfort
Time Frame: Day 1
|
10-point visual analog scale
|
Day 1
|
Overall technical ease
Time Frame: Day 1
|
10-point visual analog scale
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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