Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection
NCT ID: NCT07198945
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
546 participants
INTERVENTIONAL
2026-01-31
2029-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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6-month follow-up
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.
6-month follow-up
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.
12-month follow-up
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.
12-month follow-up
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.
Interventions
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6-month follow-up
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.
12-month follow-up
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.
Eligibility Criteria
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Inclusion 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
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)
18 Years
ALL
No
Sponsors
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Indiana University
OTHER
Responsible Party
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John J. Guardiola
Assistant Professor of Clinical Medicine
Principal Investigators
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John J Guardiola, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Indiana University
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Rachel E Lahr, BA
Role: primary
Jeremiah Shultz, BS
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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22913
Identifier Type: -
Identifier Source: org_study_id