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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Colonoscope | Active Comparator | Standard colonoscopy performed with adult colonoscope. |
|
| Pediatric Colonoscope | Active Comparator | Standard colonoscopy performed with pediatric colonoscope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy | Device | Standard Colonoscopy with photo documentation and the recording of procedure timing. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Weston | Weston | Florida | 33331 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42007569 | Derived | Ahmad AI, Ansari Z, Jamal Al-Din T, Nicolas MA, Restrepo D, Almomani A, Zahid E, Gonzalez A, Klein D, Jimenez B, Castro F, Ur Rahman A. Pediatric vs Adult Colonoscopes' Effectiveness in Obese Patients: The PACE Randomized Clinical Trial. Am J Gastroenterol. 2026 Apr 20. doi: 10.14309/ajg.0000000000004027. Online ahead of print. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Colonoscope | Use of the adult colonoscope to perform the colonoscopy. |
| FG001 | Pediatric Colonoscope | Use of the pediatric colonoscope to perform the colonoscopy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Colonoscope | Use of the adult colonoscope to perform the colonoscopy. |
| BG001 | Pediatric Colonoscope | Use of the pediatric colonoscope to perform the colonoscopy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | During Surgery, up to 10 minutes |
|
From enrollment until the end of the of the colonoscopy, up to 1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adult Colonoscope | Standard colonoscopy performed with adult colonoscope. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Asad Ur Rahman/ Principal Investigator | Cleveland Clinic Florida (Weston Hospital) | 9546595000 | 5646 | rahmanf3@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2025 | Feb 1, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Indication for Colonoscopy | Number of participants per type of colonoscopy | Count of Participants | Participants |
|
| History of Abdominal or Pelvic Surgery | Number of participants who have had abdominal or pelvic surgery | Count of Participants | Participants |
|
| Ottawa Bowel Prep Score | The score evaluates bowel preparation in the three main compartments of the large intestine from 0-4. 0 being excellent prep and 4 being inadequate. The three scores are added to a total fluid score ranging 1-2 to give a final score. The scale has a range from 0 (perfect) to 14 (a completely unprepared colon). | Mean | Standard Deviation | unit on a scale |
|
| Diverticulosis | Number of participants with diverticulosis | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | During Surgery |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | During Surgery |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Minutes | During Surgery |
|
|
|
| Secondary | 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...) | Posted | Mean | Standard Deviation | Minutes | During Surgery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | During Surgery |
|
|
|
| 122 |
| 0 |
| 122 |
| 0 |
| 122 |
| EG001 | Pediatric Colonoscope | Standard colonoscopy performed with pediatric colonoscope. | 0 | 122 | 0 | 122 | 0 | 122 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |