Trial Outcomes & Findings for Randomized Controlled Trial Comparing Adult to Pediatric Colonoscope in Obese Patients. (NCT NCT06776913)
NCT ID: NCT06776913
Last Updated: 2026-03-20
Results Overview
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.
COMPLETED
NA
244 participants
During Surgery, up to 10 minutes
2026-03-20
Participant Flow
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.
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.
Participant milestones
| Measure |
Adult Colonoscope
Use of the adult colonoscope to perform the colonoscopy.
|
Pediatric Colonoscope
Use of the pediatric colonoscope to perform the colonoscopy.
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
122
|
|
Overall Study
COMPLETED
|
122
|
122
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Controlled Trial Comparing Adult to Pediatric Colonoscope in Obese Patients.
Baseline characteristics by cohort
| Measure |
Adult Colonoscope
n=122 Participants
Use of the adult colonoscope to perform the colonoscopy.
|
Pediatric Colonoscope
n=122 Participants
Use of the pediatric colonoscope to perform the colonoscopy.
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 Years
STANDARD_DEVIATION 12.2 • n=154 Participants
|
57.9 Years
STANDARD_DEVIATION 13.0 • n=151 Participants
|
58.5 Years
STANDARD_DEVIATION 12.6 • n=305 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=154 Participants
|
54 Participants
n=151 Participants
|
105 Participants
n=305 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=154 Participants
|
68 Participants
n=151 Participants
|
139 Participants
n=305 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=154 Participants
|
46 Participants
n=151 Participants
|
92 Participants
n=305 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=154 Participants
|
76 Participants
n=151 Participants
|
152 Participants
n=305 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=154 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=305 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
83 Participants
n=154 Participants
|
89 Participants
n=151 Participants
|
172 Participants
n=305 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
28 Participants
n=154 Participants
|
25 Participants
n=151 Participants
|
53 Participants
n=305 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
11 Participants
n=154 Participants
|
8 Participants
n=151 Participants
|
19 Participants
n=305 Participants
|
|
Indication for Colonoscopy
Screening for Colon Cancer
|
86 Participants
n=154 Participants
|
86 Participants
n=151 Participants
|
172 Participants
n=305 Participants
|
|
Indication for Colonoscopy
Surveillance of Colon polyps
|
36 Participants
n=154 Participants
|
36 Participants
n=151 Participants
|
72 Participants
n=305 Participants
|
|
History of Abdominal or Pelvic Surgery
|
43 Participants
n=154 Participants
|
51 Participants
n=151 Participants
|
94 Participants
n=305 Participants
|
|
Ottawa Bowel Prep Score
|
4.21 unit on a scale
STANDARD_DEVIATION 2.15 • n=154 Participants
|
4.51 unit on a scale
STANDARD_DEVIATION 2.18 • n=151 Participants
|
4.36 unit on a scale
STANDARD_DEVIATION 2.16 • n=305 Participants
|
|
Diverticulosis
|
55 Participants
n=154 Participants
|
63 Participants
n=151 Participants
|
118 Participants
n=305 Participants
|
PRIMARY outcome
Timeframe: During Surgery, up to 10 minutesThe 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.
Outcome measures
| Measure |
Adult Colonoscope
n=122 Participants
Standard colonoscopy performed with adult colonoscope.
|
Pediatric Colonoscope
n=122 Participants
Standard colonoscopy performed with pediatric colonoscope.
|
|---|---|---|
|
Composite of Reaching the Cecum in Less Than 10 Minutes Without Changing the Scope Type.
|
113 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: During SurgeryNumber of Participants with successful advancement of colonoscope to the cecum. Cecal intubation rate (CIR)
Outcome measures
| Measure |
Adult Colonoscope
n=122 Participants
Standard colonoscopy performed with adult colonoscope.
|
Pediatric Colonoscope
n=122 Participants
Standard colonoscopy performed with pediatric colonoscope.
|
|---|---|---|
|
Number of Participants With Successful Advancement of Colonoscope to the Cecum
|
118 Participants
|
119 Participants
|
SECONDARY outcome
Timeframe: During SurgeryNumber of Participants with successful advancement of colonoscope to the terminal ileum. Terminal ileum intubation rate (TIIR)
Outcome measures
| Measure |
Adult Colonoscope
n=122 Participants
Standard colonoscopy performed with adult colonoscope.
|
Pediatric Colonoscope
n=122 Participants
Standard colonoscopy performed with pediatric colonoscope.
|
|---|---|---|
|
Number of Participants With Successful Advancement of Colonoscope to the Terminal Ileum
|
92 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: During SurgeryTime taken to advance the colonoscope from the rectum to the cecum. Insertion time (IT)
Outcome measures
| Measure |
Adult Colonoscope
n=122 Participants
Standard colonoscopy performed with adult colonoscope.
|
Pediatric Colonoscope
n=122 Participants
Standard colonoscopy performed with pediatric colonoscope.
|
|---|---|---|
|
Time Taken to Advance the Colonoscope From the Rectum to the Cecum.
|
4.45 Minutes
Standard Deviation 2.66
|
4.20 Minutes
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: During SurgeryTime from terminal ileum picture or last cecal picture to rectal picture. Subtract 1 min per each intervention (polypectomy, cauterization...)
Outcome measures
| Measure |
Adult Colonoscope
n=122 Participants
Standard colonoscopy performed with adult colonoscope.
|
Pediatric Colonoscope
n=122 Participants
Standard colonoscopy performed with pediatric colonoscope.
|
|---|---|---|
|
Time Taken to Withdraw Colonoscope From Cecum to Rectum (Withdrawal Time)
|
10.9 Minutes
Standard Deviation 3.36
|
11.5 Minutes
Standard Deviation 3.96
|
SECONDARY outcome
Timeframe: During SurgeryUsing ancillary maneuvers during colonoscopy (position change, pressure application, increase stiffness, etc...) to facilitate colonoscope advancement through the colon.
Outcome measures
| Measure |
Adult Colonoscope
n=122 Participants
Standard colonoscopy performed with adult colonoscope.
|
Pediatric Colonoscope
n=122 Participants
Standard colonoscopy performed with pediatric colonoscope.
|
|---|---|---|
|
Ancillary Maneuvers Used to Facilitate Colonoscope Advancement
|
28 Participants
|
31 Participants
|
Adverse Events
Adult Colonoscope
Pediatric Colonoscope
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Asad Ur Rahman/ Principal Investigator
Cleveland Clinic Florida (Weston Hospital)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place