← Back to all trials
Enrolling By Invitation
NCT07198945
Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection
Conditions: Colon Polyp, Adenoma, Serrated Polyp, Recurrence, Local Neoplasm, Endoscopic Resection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 546
Sponsor: Indiana University
Location: University of Alabama at Birmingham Birmingham Alabama
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 Criteria:
Patient Criteria
1. ≥ 18 years of age
2. Ability to provide informed consent
3. Willing and able to complete one electronic survey
4. Presenting for colonoscopy for any indication
5. 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
6. Size 20-50 mm as documented with photo containing open snare of known size as comparison.
7. Histology without high grade dysplasia:
1. Conventional Adenoma: adenoma with or without villous components
2. Serrated: hyperplastic or sessile serrated lesion
Exclusion Criteria:
Patient Criteria
1. Patients with confirmed diagnosis of inflammatory bowel disease, including Ulcerative Colitis and Crohn's Disease.
2. 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
3. Patients who have high grade dysplasia found in any polyp ≥ 20 mm removed at the index colonoscopy
4. Patients who have any colorectal cancer by histologic diagnosis at index procedure
5. 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.
6. ASA ≥ 4 or documented coagulopathy or severe thrombocytopenia (INR ≥ 2 or platelets ≤ 20).
7. Patients who have more than three ≥ 20mm polyps removed during the index colonoscopy
8. Patients with significant medical problems that could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study per the judgement of the investigator.
Polyp Criteria
9. Polyp located at appendiceal orifice, ileocecal valve, or intradiverticulum
10. Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)
11. A polyp that is classified as a traditional serrated adenoma.
12. Polyps with features of invasive cancer
13. Polyps that are not able to be removed with standard endoscopic techniques for any reason
14. Polyps that are incompletely resected endoscopically at index procedure
15. Polyps removed by endoscopic submucosal dissection (ESD) or by full thickness resection device (FTRD)
Source: ClinicalTrials.gov (NCT07198945). StuddyBuddy aggregates publicly available trial information.