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N/A N=346 Randomized Double-blind Prevention

Effectiveness of Abdominal Binder Use During Colonoscopy

Performance and Tolerance of Colonoscopy

Enrolled (actual)
346
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Mean Cecal Intubation Time — 240; 250 sec — p=0.388

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Abdominal Binder (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Primary completion
Aug 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Cecal Intubation Time
240; 250 0.388
SECONDARY
Number of Participants Who Required Ancillary Maneuvers
65; 85 0.069
SECONDARY
Length of Cecal Intubation
89; 88.5 0.487
SECONDARY
Number of Participants Who Completed the Procedure
169; 168 0.822
SECONDARY
Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug
43; 64 0.016 sig
SECONDARY
Patient Pain and Comfort Level at Discharge
1.9; 3.3; 1.7; 1.7 0.001 sig
SECONDARY
Number of Participants According to Colonoscopy Findings
72; 70; 60; 59; 38; 42 0.184

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04383132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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