Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
Study NCT ID:
NCT04383132
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2020-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of Abdominal Binder Use During Colonoscopy
Sponsor:
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Organization:
Study Overview
Official Title:
Does Using Abdominal Binder Really Benefit During Colonoscopy ?: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: