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Recruiting
NCT05617521
Abdominal Binder in Colonoscopies Performed by Trainees
Conditions: Performance of Colonoscopy, Tolerance of Colonoscopy
Sex: All
Ages: 20 Years – 80 Years
Phase: NA
Enrollment: 206
Sponsor: Hospital Central Norte PEMEX
Location: Mexico
Summary
This randomized trial will be conducted to evaluate the effectiveness and safety of an abdominal binder use during colonoscopy performed by gastrointestinal endoscopy fellow trainees.
The investigators hypothesized that the abdominal binder use would facilitate and increase the effectiveness of the colonoscopy for inexperienced operators.
Eligibility Criteria
Inclusion Criteria:Male and female adults between the ages of 20-80Participants with ASA I-III (American Society of Anesthesiologists Class)Undergoing a colonoscopy at any of the study locations for:I. CRC screening (first colonoscopy or 10 years follow up of negative exam).
II.
Surveillance (prior colonoscopy with polyps).
III.
Diagnostic colonoscopy performed to evaluate symptoms such as abdominal pain or rectal bleeding.- Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure and describe adequate cleansing.Exclusion Criteria:Inability to provide informed consent.Patients with known or suspected pregnancy.Patients undergoing multiple procedures (e.g., upper and lower endoscopy).Previous colon resection surgery.History of problems with sedation or anesthesia.Patients with known or suspected diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease).Patients with a history of colorectal cancer or other intra-abdominal malignancy.Patients with open or recent wounds or skin rash on the anterior abdominal wall.History of cirrhosis or ascites.Patients who are medically unstable (American Society of Anesthesiology Class IV or above).
Source: ClinicalTrials.gov (NCT05617521). StuddyBuddy aggregates publicly available trial information.