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

NCT07198945 | Not Yet Recruiting DMC

• 1 other identifier: 22913
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Polyp Resection; Colonoscopy; Recurrence; Surveillance Interval; Patient Experience

Outcome Measures

Primary Outcomes (1)

• Rate of recurrence

  Rate of recurrence will be assessed by identification of recurrent polyp tissue at the follow-up procedure.

  1 day

Secondary Outcomes (14)

• Time of endoscopic management of recurrent polyp

  At first surveillance colonoscopy, typically 6 months to 12 months

• Perceived difficulty of endoscopic treatment of recurrent polyp

  At first surveillance colonoscopy, typically 6 months to 12 months

• Rate of malignancy identified at first surveillance colonoscopy

  At first surveillance colonoscopy, typically 6 months to 12 months

• Size of recurrent polyp at first surveillance colonoscopy

  At first surveillance colonoscopy, typically 6 months to 12 months

• Number of distinct areas of recurrent polyp

  At first surveillance colonoscopy, typically 6 months to 12 months

Study Arms (2)

6-month follow-up

EXPERIMENTAL

Patients will be recommended to complete their first surveillance procedure 6 months after the large polyp removal procedure in order to assess whether the polyp grew back.

Procedure: 6-month follow-up

12-month follow-up

EXPERIMENTAL

Patients will be recommended to complete their first surveillance procedure 12 months after the large polyp removal procedure in order to assess whether the polyp grew back.

Procedure: 12-month follow-up

Interventions

6-month follow-up PROCEDURE

Eligible patients randomized to the 6-month follow-up arm will undergo their first surveillance procedure 6 months after the removal of their large polyp to check for recurrent polyp tissue.

6-month follow-up

12-month follow-up PROCEDURE

Eligible patients randomized to the 12-month follow-up arm will undergo their first surveillance procedure 12 months after the removal of their large polyp to check for recurrent polyp tissue.

12-month follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (12)

• Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1095-1129. doi: 10.1053/j.gastro.2019.12.018. Epub 2020 Feb 11. No abstract available.

  PMID: 32122632 BACKGROUND

• Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available.

  PMID: 32044092 BACKGROUND

• El Rahyel A, Abdullah N, Love E, Vemulapalli KC, Rex DK. Recurrence After Endoscopic Mucosal Resection: Early and Late Incidence, Treatment Outcomes, and Outcomes in Non-Overt (Histologic-Only) Recurrence. Gastroenterology. 2021 Feb;160(3):949-951.e2. doi: 10.1053/j.gastro.2020.10.039. Epub 2020 Oct 29. No abstract available.

  PMID: 33130101 BACKGROUND

• Tate DJ, Desomer L, Argenziano ME, Mahajan N, Sidhu M, Vosko S, Shahidi N, Lee E, Williams SJ, Burgess NG, Bourke MJ. Treatment of adenoma recurrence after endoscopic mucosal resection. Gut. 2023 Oct;72(10):1875-1886. doi: 10.1136/gutjnl-2023-330300. Epub 2023 Jul 6.

  PMID: 37414440 BACKGROUND

• Mohapatra S, Almazan E, Charilaou P, et al. Outcomes of Endoscopic Resection for Colorectal Polyps With High-Grade Dysplasia or Intramucosal Cancer. Techniques and Innovations in Gastrointestinal Endoscopy 2023;25:119-126.

  BACKGROUND

• Parsa N, Ponugoti P, Broadley H, Garcia J, Rex DK. Risk of cancer in 10 - 19 mm endoscopically detected colorectal lesions. Endoscopy. 2019 May;51(5):452-457. doi: 10.1055/a-0799-9997. Epub 2019 Jan 8.

  PMID: 30620947 BACKGROUND

• McWhinney CD, Vemulapalli KC, El Rahyel A, Abdullah N, Rex DK. Adverse events and residual lesion rate after cold endoscopic mucosal resection of serrated lesions >/=10 mm. Gastrointest Endosc. 2021 Mar;93(3):654-659. doi: 10.1016/j.gie.2020.08.032. Epub 2020 Sep 3.

  PMID: 32891621 BACKGROUND

• Bobay MC, Lahr RE, Shultz J, Vemulapalli KC, Guardiola JJ, Rex DK. Safety of first surveillance colonoscopy at 12 months after piecemeal EMR of large nonpedunculated colorectal lesions. Gastrointest Endosc. 2024 Nov;100(5):905-913. doi: 10.1016/j.gie.2024.05.008. Epub 2024 May 14.

  PMID: 38750975 BACKGROUND

• Lacroute J, Marcantoni J, Petitot S, Weber J, Levy P, Dirrenberger B, Tchoumak I, Baron M, Gibert S, Marguerite S, Huppertz J, Gronier O, Derlon A. The carbon footprint of ambulatory gastrointestinal endoscopy. Endoscopy. 2023 Oct;55(10):918-926. doi: 10.1055/a-2088-4062. Epub 2023 May 8.

  PMID: 37156511 BACKGROUND

• Lopez-Munoz P, Martin-Cabezuelo R, Lorenzo-Zuniga V, Vilarino-Feltrer G, Tort-Ausina I, Vidaurre A, Pons Beltran V. Life cycle assessment of routinely used endoscopic instruments and simple intervention to reduce our environmental impact. Gut. 2023 Sep;72(9):1692-1697. doi: 10.1136/gutjnl-2023-329544. Epub 2023 Apr 26.

  PMID: 37185655 BACKGROUND

• Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.

  PMID: 24671869 BACKGROUND

• Pohl H, Rex DK, Barber J, Moyer MT, Elmunzer BJ, Rastogi A, Gordon SR, Zolotarevsky E, Levenick JM, Aslanian HR, Elatrache M, von Renteln D, Wallace MB, Brahmbhatt B, Keswani RN, Kumta NA, Pleskow DK, Smith ZL, Abu Ghanimeh MK, Simmer S, Sanaei O, Mackenzie TA, Piraka C. Cold snare endoscopic resection for large colon polyps: a randomised trial. Gut. 2025 Oct 8;74(11):1804-1813. doi: 10.1136/gutjnl-2025-335075.

  PMID: 40393701 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Colonic Polyps; Adenoma; Neoplasm Recurrence, Local; Recurrence

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Disease Attributes

Study Officials

• John J Guardiola, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel E Lahr, BA

CONTACT

317-278-2328; rlahr@iu.edu

Jeremiah Shultz, BS

CONTACT

317-278-6222; drrexgi@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)