Effectiveness of Abdominal Binder Use During Colonoscopy

Study Overview
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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.

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

Conditions
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Performance and Tolerance of Colonoscopy

Intervention / Treatment
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* Device: Abdominal Binder


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal Binder Intervention Group<br>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<br>* abdominal binder is a kind of elastic abdominal compression device<br>|
| Sham Comparator: Sham Group<br>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<br>* abdominal binder is a kind of elastic abdominal compression device<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal binder, colonoscopy, loop