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

Cleveland Clinic Florida244 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

244

Conditions

Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2)Screening Colonoscopy

Interventions

ColonoscopyDEVICE

Standard Colonoscopy with photo documentation and the recording of procedure timing.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Weston

Weston, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: During Surgery, up to 10 minutes

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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...)

Time frame: 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.

Time frame: During Surgery

Data from ClinicalTrials.gov

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