Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2), Screening Colonoscopy
Conditions
Keywords
obesity, Screening Colonoscopy
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. Endoscopist pick which one to use based on personal preference and what is available.
Interventions
DEVICEColonoscopy
Standard Colonoscopy with photo documentation and the recording of procedure timing.
Sponsors
Cleveland Clinic Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Reaching the Cecum in Less Than 10 Minutes Without Changing the Scope Type. | During Surgery, up to 10 minutes | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Advancement of Colonoscope to the Cecum | During Surgery | Number of Participants with successful advancement of colonoscope to the cecum. Cecal intubation rate (CIR) |
| Number of Participants With Successful Advancement of Colonoscope to the Terminal Ileum | During Surgery | Number of Participants with successful advancement of colonoscope to the terminal ileum. Terminal ileum intubation rate (TIIR) |
| Time Taken to Advance the Colonoscope From the Rectum to the Cecum. | During Surgery | Time taken to advance the colonoscope from the rectum to the cecum. Insertion time (IT) |
| Time Taken to Withdraw Colonoscope From Cecum to Rectum (Withdrawal Time) | During Surgery | Time from terminal ileum picture or last cecal picture to rectal picture. Subtract 1 min per each intervention (polypectomy, cauterization...) |
| Ancillary Maneuvers Used to Facilitate Colonoscope Advancement | During Surgery | Using ancillary maneuvers during colonoscopy (position change, pressure application, increase stiffness, etc...) to facilitate colonoscope advancement through the colon. |
Countries
United States
Participant flow
Recruitment details
During the time period of January to September 2025 adult patients with a BMI 30 kg/m\^2 scheduled for screening or surveillance colonoscopy at Cleveland Clinic Weston and Coral Springs locations with five experienced endoscopist were screened and invited to participate.
Pre-assignment details
After obtaining consent participants were randomized in a 1:1 ratio to either use of the adult or pediatric colonoscope on the day of the procedure. The randomization was stratified by the providers performing the colonoscopies to ensure that each provider received an equal number of patients from both study groups.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.2 Years STANDARD_DEVIATION 12.2 |
| Diverticulosis | 55 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 92 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| History of Abdominal or Pelvic Surgery | 94 Participants |
| Indication for Colonoscopy Screening for Colon Cancer | 86 Participants |
| Indication for Colonoscopy Surveillance of Colon polyps | 72 Participants |
| Ottawa Bowel Prep Score | 4.21 unit on a scale STANDARD_DEVIATION 2.15 |
| Race/Ethnicity, Customized Race Black | 25 Participants |
| Race/Ethnicity, Customized Race Other | 19 Participants |
| Race/Ethnicity, Customized Race White | 89 Participants |
| Sex: Female, Male Female | 105 Participants |
| Sex: Female, Male Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 122 | 0 / 122 |
| other Total, other adverse events | 0 / 122 | 0 / 122 |
| serious Total, serious adverse events | 0 / 122 | 0 / 122 |
Outcome results
None listed