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Effectiveness of Abdominal Binder Use During Colonoscopy

NCT ID: NCT04383132

Last Updated: 2020-11-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2020-08-15

Brief Summary

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Colonoscopy is considered the primary screening test for colorectal cancer screening worldwide. For technical difficulties previously experienced during colonoscopy, especially loop of the colonoscopy device in the colon, many solution methods have been developed and applied (manual pressure and position change, etc.). Although these methods are partially successful, there is no consensus on the optimum solution method. Few studies in the literature have investigated the use of corset during colonoscopy and conflicting results have been reported. In this study, elastic abdominal corset or false corset will be used during colonoscopy. Indeed, the investigators aim to determine whether this method is effective and safe with their own results and contribute to the literature. The primary outcome of this study will be the cecal intubation time. Secondary outcomes include manual pressure and position change during the procedure, length of cecal intubation (length of colonoscope required to reach the cecum from the anus), colonoscopy completion rate, additional anesthesia and / or analgesic requirement, patient pain and comfort level and colonoscopic findings.Efficacy will be assessed on the basis of pairwise comparisons between groups with respect to primary and secondary outcomes.

Detailed Description

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Conditions

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Performance and Tolerance of Colonoscopy

Keywords

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abdominal binder colonoscopy loop

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Abdominal Binder Intervention Group

Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy.

Group Type EXPERIMENTAL

Abdominal Binder

Intervention Type DEVICE

abdominal binder is a kind of elastic abdominal compression device

Sham Group

Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure

Group Type SHAM_COMPARATOR

Abdominal Binder

Intervention Type DEVICE

abdominal binder is a kind of elastic abdominal compression device

Interventions

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Abdominal Binder

abdominal binder is a kind of elastic abdominal compression device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Between the ages of 18 - 90 Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure, and describe adequate cleansing.

Participants with ASA I-III (American Society of Anesthesiologists Class III)

Exclusion Criteria

Previous colon resection History of intra-abdominal malignancy Known anesthetic or analgesic drugs allergy Multiple planned procedures (e.g.bidirectional endoscopy) Pregnancy Active inflammatory bowel disease A history of intraabdominal malignancy History of cirrhosis or ascites Known ventral hernia
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Beslen Goksoy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beslen Göksoy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Locations

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Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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Beslen-korse

Identifier Type: -

Identifier Source: org_study_id