NCT04383132

Effectiveness of Abdominal Binder Use During Colonoscopy

Completed NA Results posted Last updated 12 November 2020

What this trial tests

NA trial testing Abdominal Binder in Performance and Tolerance of Colonoscopy in 346 participants. Completed in 15 August 2020.

Timeline

15 May 2020

Primary endpoint
15 August 2020

15 August 2020

Quick facts

Lead sponsor	Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	346
Start date	15 May 2020
Primary completion	15 August 2020
Estimated completion	15 August 2020
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Abdominal Binder

Conditions studied

• Performance and Tolerance of Colonoscopy — all drugs for Performance and Tolerance of Colonoscopy →

Sponsor

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Who can join

Adults 18 to 90, any sex, with Performance and Tolerance of Colonoscopy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Cecal Intubation Time Primary · 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

Group	Value	95% CI
Abdominal Binder Intervention Group	240	± 110
Sham Group	250	± 115

Number of Participants Who Required Ancillary Maneuvers Secondary · 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.

Group	Value	95% CI
Abdominal Binder Intervention Group	65
Sham Group	85

Length of Cecal Intubation Secondary · 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

Group	Value	95% CI
Abdominal Binder Intervention Group	89	± 18
Sham Group	88.5	± 15

Number of Participants Who Completed the Procedure Secondary · 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.

Group	Value	95% CI
Abdominal Binder Intervention Group	169
Sham Group	168

Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug Secondary · 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

Group	Value	95% CI
Abdominal Binder Intervention Group	43
Sham Group	64

Patient Pain and Comfort Level at Discharge Secondary · 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) )

VAS score

Group	Value	95% CI
Abdominal Binder Intervention Group	1.9	± 1.6
Sham Group	3.3	± 1.8

patient satisfaction score

Group	Value	95% CI
Abdominal Binder Intervention Group	1.7	± 0.9
Sham Group	1.7	± 0.9

Number of Participants According to Colonoscopy Findings Secondary · 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.

Group	Value	95% CI
Abdominal Binder Intervention Group	72
Sham Group	70
Abdominal Binder Intervention Group	60
Sham Group	59
Abdominal Binder Intervention Group	38
Sham Group	42
Abdominal Binder Intervention Group	0
Sham Group	2

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.