Status:
NOT_YET_RECRUITING
Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection
Lead Sponsor:
Indiana University
Conditions:
Colon Cancer
Colon Polyp
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study will compare the use of a 6-month follow-up vs a 12-month follow-up after the removal of a large non-pedunculated polyp 20-50mm in size and without high grade dysplasia.
Eligibility Criteria
Inclusion
- Patient Criteria
- ≥ 18 years of age
- Ability to provide informed consent
- Willing and able to complete one electronic survey
- Presenting for colonoscopy for any indication
- Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments.
- Polyp Criteria
- Size 20-50 mm as documented with photo containing open snare of known size as comparison.
- Histology without high grade dysplasia:
- Conventional Adenoma: adenoma with or without villous components
- Serrated: hyperplastic or sessile serrated lesion
Exclusion
- Patient Criteria
- Patients with confirmed diagnosis of inflammatory bowel disease, including Ulcerative Colitis and Crohn's Disease.
- Patients with a known or suspected diagnosis of any of the following polyposis or non-polyposis syndromes with known genetic mutations:
- Familial Adenomatous Polyposis Syndrome
- MUTYH associated Polyposis Syndrome
- Juvenile Polyposis Syndrome
- Cowden's Syndrome
- Peutz-Jeghers Syndrome
- Hereditary Non-Polyposis Colorectal Cancer Syndrome (HNPCC) or Lynch Syndrome
- Patients who have high grade dysplasia found in any polyp ≥ 20 mm removed at the index colonoscopy
- Patients who have any colorectal cancer by histologic diagnosis at index procedure
- Patients needing a colonoscopy 6 months or sooner for any indication following the index procedure including burden of synchronous disease, inadequate prep to assess for synchronous disease, inadequate prep that precludes resection of index large polyp, or other reason limiting ability to complete full examination of colon at time of resection.
- ASA ≥ 4 or documented coagulopathy or severe thrombocytopenia (INR ≥ 2 or platelets ≤ 20).
- Patients who have more than three ≥ 20mm polyps removed during the index colonoscopy
- Patients with significant acute or chronic medical, neurologic, or illness that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
- Polyp Criteria
- Polyp located at appendiceal orifice, ileocecal valve, or intradiverticulum
- Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- A polyp that is classified as a traditional serrated adenoma.
- Polyps with features of invasive cancer
- Polyps that are not able to be removed with standard endoscopic techniques for any reason
- Polyps that are incompletely resected endoscopically at index procedure
- Polyps removed by endoscopic submucosal dissection (ESD) or by full thickness resection device (FTRD)
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT07198945
Start Date
January 1 2026
End Date
September 1 2029
Last Update
December 24 2025
Active Locations (1)
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1
Indiana University
Indianapolis, Indiana, United States, 46202