Clinical trial NCT04383132: Effectiveness of Abdominal Binder Use During Colonoscopy
Official title: Does Using Abdominal Binder Really Benefit During Colonoscopy ?: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Performance and Tolerance of Colonoscopy
Keywords: abdominal binder
colonoscopy
loop
Lead sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Mean Cecal Intubation Time
timeFrame: 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 outcomes:
measure: Number of Participants Who Required Ancillary Maneuvers
timeFrame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified, an average of 1-30 minutes
measure: Length of Cecal Intubation
timeFrame: From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes
measure: Number of Participants Who Completed the Procedure
timeFrame: 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
measure: Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug
timeFrame: 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
measure: Patient Pain and Comfort Level at Discharge
timeFrame: At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes
measure: Number of Participants According to Colonoscopy Findings
timeFrame: 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
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Study officials:
affiliation: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
name: Beslen Göksoy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: