Effectiveness of Abdominal Binder Use During Colonoscopy

Not Applicable

Completed

Conditions: Performance and Tolerance of Colonoscopy

Interventions: Device: Abdominal Binder

Registration Number: NCT04383132

Lead Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

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: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 346

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abdominal Binder Intervention Group	Abdominal Binder	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.
Sham Group	Abdominal Binder	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

Primary Outcome Measures

Name	Time	Method
Mean Cecal Intubation Time	During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified,an average of 1-30 minutes	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Completed the Procedure	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	Dichotomous outcome indicating if the procedure was incomplete or complete.
Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug	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	Whether the patient needs an additional dose of anesthetic and / or analgesic drug to complete the colonoscopy
Number of Participants Who Required Ancillary Maneuvers	During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified, an average of 1-30 minutes	Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded.
Length of Cecal Intubation	From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes	The length of the colonoscope required to reach the cecum from the anus will be measured
Patient Pain and Comfort Level at Discharge	At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes	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) )
Number of Participants According to Colonoscopy Findings	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	Findings such as polyp, cancer, diverticulum detected during colonoscopy will be recorded.