Randomized Controlled Trial Comparing Adult to Pediatric Colonoscope in Obese Patients.

Not Applicable

Recruiting

• Conditions: Obesity (body Mass Index >30 Kg/m2); Screening Colonoscopy

• Registration Number: NCT06776913
• Lead Sponsor: Cleveland Clinic Florida

Brief Summary

The goal of this study is to test which colonoscope works best in people who are above a certain body mass index. Currently, both pediatric and adult colonoscopes are accepted as standard treatments in colonoscopies. Doctors pick which one to use based on personal preference and what is available.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-06
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

• BMI greater than 30
• Screening and surveillance colonoscopy

Exclusion Criteria

• Colon surgery
• Therapeutic colonoscopy
• Inflammatory bowel disease
• Terminated procedure due to stool burden, stenosis, or obstructive mass.
• Colonoscopy for anemia
• History of incomplete colonoscopy due to technical difficulties

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite of reaching the cecum in less than 10 minutes without changing the scope type.	From time of randomization to end of procedure. Assessed day of surgery.	The outcome aims to measure the difficult colonoscope which is defined as either not reaching the cecum, needing more than 10 minutes, or the need to exchange to a different device.

Secondary Outcome Measures

Name	Time	Method
Cecal intubation rate (CIR)	From time of randomization to end of procedure. Assessed day of surgery.	The percentage of successful advancement of colonoscope to the cecum.
Terminal ileum intubation rate (TIIR)	From time of randomization to end of procedure. Assessed day of surgery.	The percentage of successful advancement of colonoscope to the terminal ileum.
Insertion time (IT)	From time of randomization to end of procedure. Assessed day of surgery.	Time from insertion to cecum.
Withdrawal time	From time of randomization to end of procedure. Assessed day of surgery.	Time from terminal ileum picture or last cecal picture to rectal picture. Subtract 1 min per each intervention (polypectomy, cauterization...)
Ancillary maneuvers used	From time of randomization to end of procedure. Assessed day of surgery.	Using ancillary maneuvers during colonoscopy (position change, pressure application, increase stiffness, etc...)

Trial Locations

Locations (1)

Cleveland Clinic Weston; 🇺🇸 Weston, Florida, United States