Effectiveness of Abdominal Binder Use During Colonoscopy

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

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 Overview

• Status: Completed
• Conditions: Performance and Tolerance of Colonoscopy
• Intervention / Treatment: Device: Abdominal Binder

• Study Type: Interventional
• Enrollment (Actual): 346
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34785
    • Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Abdominal Binder; abdominal binder is a kind of elastic abdominal compression device
Sham Comparator: 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	Device: Abdominal Binder; abdominal binder is a kind of elastic abdominal compression device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Cecal Intubation Time	Cecal intubation time will be defined as the time from insertion of the colonoscope into the rectum to identification of the base of the cecum	During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified,an average of 1-30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Required Ancillary Maneuvers	Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded.	During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified, an average of 1-30 minutes
Length of Cecal Intubation	The length of the colonoscope required to reach the cecum from the anus will be measured	From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes
Number of Participants Who Completed the Procedure	Dichotomous outcome indicating if the procedure was incomplete or complete.	During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes
Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug	Whether the patient needs an additional dose of anesthetic and / or analgesic drug to complete the colonoscopy	During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes
Patient Pain and Comfort Level at Discharge	Study assistant will interview patient just prior to discharge and obtain responses for pain according to 10-point visual analog scales ( scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" =1 (min) and "worst pain"=10 (max)) and global satisfaction according to a 5-point scale ( scores are recorded by making a handwritten mark on a 5-cm line that represents a continuum between "very unsatisfied" =1 (min) and "very satisfied"=5 (max) )	At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes
Number of Participants According to Colonoscopy Findings	Findings such as polyp, cancer, diverticulum detected during colonoscopy will be recorded.	During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes

Collaborators and Investigators

• Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Investigators: Principal Investigator: Beslen Göksoy, M.D., Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): August 15, 2020
• Study Completion (Actual): August 15, 2020

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: colonoscopy; abdominal binder; loop
• Other Study ID Numbers: Beslen-korse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No