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

NCT ID: NCT03016962

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1046 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2021-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insertion Time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Cap-assisted colonoscopy

cap-assisted colonoscopy

Group Type EXPERIMENTAL

cap-assisted colonoscopy

Intervention Type DEVICE

cap-assisted colonoscopy

Standard colonoscopy

Standard colonoscopy

Group Type ACTIVE_COMPARATOR

Standard colonoscopy

Intervention Type DEVICE

Standard colonoscopy

Interventions

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cap-assisted colonoscopy

cap-assisted colonoscopy

Intervention Type DEVICE

Standard colonoscopy

Standard colonoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with history of abdominal or pelvic surgery

Exclusion Criteria

* Previous colorectal resection
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Seon Ji

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Cap

Identifier Type: -

Identifier Source: org_study_id

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