Clinical trial · Interventional
Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy
Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy: A Randomized Tandem Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Futility
Summary
Brief summary (as posted)
The investigators' null hypothesis is that a withdrawal time of 9 to 10 minutes is non-inferior to a withdrawal time of 12 minutes or greater. Thus, the goal of this tandem design trial is to compare the additional diagnostic yield (# of missed lesions) for withdrawal times exceeding 10 minutes for screening/surveillance colonoscopies. Although withdrawal times longer than the standard 6-minute recommendation have been shown to be beneficial, there is limited prospective evidence investigating the benefit or lack thereof for withdrawal times greater than 9-10 minutes.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy 12 minute withdrawal | Procedure | — | UNRESOLVED |
| Colonoscopy 9 minute withdrawal | Procedure | — | UNRESOLVED |
| Colonoscopy with 6 minute withdrawal | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1: Colonoscopy 6 minute withdrawal time
- description
- -Undergo colonoscopy with the standard 6-minute withdrawal time followed by a tandem colonoscopy of at least another 6-minute withdrawal time.
- interventionNames
- Procedure: Colonoscopy with 6 minute withdrawal
- type
- EXPERIMENTAL
- label
- Arm 2: Colonoscopy 9 minute withdrawal time
- description
- -Undergo a 9-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time.
- interventionNames
- Procedure: Colonoscopy 9 minute withdrawal
- type
- EXPERIMENTAL
- label
- Arm 3: Colonoscopy 12 minute withdrawal time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Must be between the ages of 18 and 75 years * Must be a patient undergoing screening or surveillance colonoscopy * Must be able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: * Inability to provide informed consent. * Personal history of colorectal cancer (CRC) * Personal history of colon surgery or colon resection * Personal history of Inflammatory bowel disease * Personal history of familial polyposis * Current pregnancy * Active GI bleeding * Colonoscopy exams where the cecum cannot be reached (randomization will occur after cecum is reached).
References
Publications (0)
Data not yet available