Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection

Not Applicable

Not yet recruiting

• Conditions: Colon Cancer; Colon Polyp; Adenoma; Serrated Polyp; Recurrence, Local Neoplasm; Endoscopic Resection

• Registration Number: NCT07198945
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-22
• Study First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Study First Posted: 2025-09-30
• Last Update Posted: 2025-09-30
• Study Start: 2025-10-01
• Primary Completion: 2029-04
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 546

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 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

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy of surveillance interval	1 day	Efficacy of surveillance interval will be assessed by identification of recurrent polyp tissue at the follow-up procedure.

Secondary Outcome Measures

Name	Time	Method
Time of endoscopic management of recurrent polyp	At first surveillance colonoscopy, typically 6 months to 12 months	The time it takes to treat recurrent polyp at the follow-up procedure
Perceived difficulty of endoscopic treatment of recurrent polyp	At first surveillance colonoscopy, typically 6 months to 12 months	Perceived difficulty of endoscopic treatment of recurrent polyp will be assessed by the endoscopist based at the follow-up procedure on Likert scale 1 - 5 from very difficult to very easy.
Rate of malignancy identified at first surveillance colonoscopy	At first surveillance colonoscopy, typically 6 months to 12 months	The rate of malignancy measured at the first follow-up colonoscopy
Size of recurrent polyp at first surveillance colonoscopy	At first surveillance colonoscopy, typically 6 months to 12 months	The size of recurrent polyp tissue as measured by maximum size in millimeters
Number of distinct areas of recurrent polyp	At first surveillance colonoscopy, typically 6 months to 12 months	The number of areas of recurrent polyp tissue identified at the site of the prior large polyp
Rate of high grade dysplasia identified in recurrent polyp	After surveillance colonoscopy, typically 6 months to 12 months	The rate of high grade dysplasia identified in recurrent polyp tissue.
Need for advanced resection techniques to treat recurrent polyp	At first surveillance colonoscopy, typically 6 months to 12 months	Whether advanced techniques (such as the use of endoscopic submucosal dissection or full thickness resection device) are needed to treat recurrent polyp tissue
Need for surgical intervention to treat recurrent polyp	At first surveillance colonoscopy, typically 6 months to 12 months	Whether surgical intervention is needed to treat recurrent polyp tissue
Types of recurrences at follow-up	At first surveillance colonoscopy, typically 6 months to 12 months	Description of whether recurrence was visible during the follow-up procedure and confirmed by pathology, visible during the follow-up procedure but not confirmed by pathology, or not visible during the follow-up procedure but confirmed by pathology.
Techniques used to treat recurrent polyp	At first surveillance colonoscopy, typically 6 months to 12 months	The different techniques that were used to treat the recurrent polyp tissue.
Patient Survey Results	Typically 1 to 14 days after the large polyp removal procedure	Patient reported experience, including patient's comfort level with prolonged index surveillance, likelihood for returning for follow-up colonoscopy with extended interval, and other factors.
Adverse events that occur after the follow-up procedure	30 days after first surveillance colonoscopy	The number of complications for each randomization arm during and after the follow-up procedure
Distance patient travelled to the endoscopy unit	At first surveillance colonoscopy, typically 6 months to 12 months	Calculation of the distance the patient travelled to the endoscopy unit as a surrogate for carbon impact
Cost of equipment used at the resection site during the follow-up colonoscopy	At first surveillance colonoscopy, typically 6 months to 12 months	The cost of the equipment that was used at the resection site during the surveillance procedure

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States