CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 346 enrolled
Drug / intervention
Abdominal Binderdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04383132
NCT04383132N/ACompleted

Does Using Abdominal Binder Really Benefit During Colonoscopy ?: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital·interventional·Posted May 12, 2020·Updated Nov 12, 2020

In Brief

A clinical study evaluating Abdominal Binder for Performance and Tolerance of Colonoscopy. Completed, enrolled 346 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 12, 2020
Enrollment StartMay 15, 2020
Primary CompletionAug 15, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.1 years ago

Interventions

Abdominal Binderdevice

abdominal binder is a kind of elastic abdominal compression device