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

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. Endoscopist pick which one to use based on personal preference and what is available.

Study Overview

• Status: Completed
• Conditions: Screening Colonoscopy; Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2)
• Intervention / Treatment: Device: Colonoscopy

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Weston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Adult Colonoscope; Standard colonoscopy performed with adult colonoscope.	Device: Colonoscopy; Standard Colonoscopy with photo documentation and the recording of procedure timing.
Active Comparator: Pediatric Colonoscope; Standard colonoscopy performed with pediatric colonoscope.	Device: Colonoscopy; Standard Colonoscopy with photo documentation and the recording of procedure timing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Reaching the Cecum in Less Than 10 Minutes Without Changing the Scope Type.	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.	During Surgery, up to 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Successful Advancement of Colonoscope to the Cecum	Number of Participants with successful advancement of colonoscope to the cecum. Cecal intubation rate (CIR)	During Surgery
Number of Participants With Successful Advancement of Colonoscope to the Terminal Ileum	Number of Participants with successful advancement of colonoscope to the terminal ileum. Terminal ileum intubation rate (TIIR)	During Surgery
Time Taken to Advance the Colonoscope From the Rectum to the Cecum.	Time taken to advance the colonoscope from the rectum to the cecum. Insertion time (IT)	During Surgery
Time Taken to Withdraw Colonoscope From Cecum to Rectum (Withdrawal Time)	Time from terminal ileum picture or last cecal picture to rectal picture. Subtract 1 min per each intervention (polypectomy, cauterization...)	During Surgery
Ancillary Maneuvers Used to Facilitate Colonoscope Advancement	Using ancillary maneuvers during colonoscopy (position change, pressure application, increase stiffness, etc...) to facilitate colonoscope advancement through the colon.	During Surgery

Collaborators and Investigators

• Sponsor: Cleveland Clinic Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Actual): September 24, 2025
• Study Completion (Actual): September 24, 2025

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: obesity; Screening Colonoscopy
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Colonoscopy
• Other Study ID Numbers: 24-891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No