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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of recurrence | Rate of recurrence will be assessed by identification of recurrent polyp tissue at the follow-up procedure. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Time of endoscopic management of recurrent polyp | The time it takes to treat recurrent polyp at the follow-up procedure | At first surveillance colonoscopy, typically 6 months to 12 months |
| Perceived difficulty of endoscopic treatment of recurrent polyp |
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Inclusion Criteria:
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:
Exclusion Criteria:
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:
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)
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| Name | Affiliation | Role |
|---|---|---|
| John J Guardiola, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35244 | United States | ||
| University of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32122632 | Background | 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. | |
| 32044092 |
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De-identified data may be shared in the future upon request per PI discretion.
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| 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. |
|
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. |
| At first surveillance colonoscopy, typically 6 months to 12 months |
| Rate of malignancy identified at first surveillance colonoscopy | The rate of malignancy measured at the first follow-up colonoscopy | At first surveillance colonoscopy, typically 6 months to 12 months |
| Size of recurrent polyp at first surveillance colonoscopy | The size of recurrent polyp tissue as measured by maximum size in millimeters | At first surveillance colonoscopy, typically 6 months to 12 months |
| Number of distinct areas of recurrent polyp | The number of areas of recurrent polyp tissue identified at the site of the prior large polyp | At first surveillance colonoscopy, typically 6 months to 12 months |
| Rate of high grade dysplasia identified in recurrent polyp | The rate of high grade dysplasia identified in recurrent polyp tissue. | After surveillance colonoscopy, typically 6 months to 12 months |
| Need for advanced resection techniques to treat recurrent polyp | Whether advanced techniques (such as the use of endoscopic submucosal dissection or full thickness resection device) are needed to treat recurrent polyp tissue | At first surveillance colonoscopy, typically 6 months to 12 months |
| Need for surgical intervention to treat recurrent polyp | Whether surgical intervention is needed to treat recurrent polyp tissue | At first surveillance colonoscopy, typically 6 months to 12 months |
| Types of recurrences at follow-up | 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. | At first surveillance colonoscopy, typically 6 months to 12 months |
| Techniques used to treat recurrent polyp | The different techniques that were used to treat the recurrent polyp tissue. | At first surveillance colonoscopy, typically 6 months to 12 months |
| Patient Survey Results | 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. This survey is multiple questions, and the responses will be reported on a 5-point Likert scale with 1 being very uncomfortable, not at all important, etc to 5 being very comfortable, very important, etc. | Typically 1 to 14 days after the large polyp removal procedure |
| Adverse events that occur after the follow-up procedure | The number of complications for each randomization arm during and after the follow-up procedure | 30 days after first surveillance colonoscopy |
| Distance patient travelled to the endoscopy unit | Calculation of the distance the patient travelled to the endoscopy unit as a surrogate for carbon impact | At first surveillance colonoscopy, typically 6 months to 12 months |
| Cost of equipment used at the resection site during the follow-up colonoscopy | The cost of the equipment that was used at the resection site during the surveillance procedure | At first surveillance colonoscopy, typically 6 months to 12 months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| The University of Kansas Medical Center | Kansas City | Kansas | 66221 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48208 | United States |
| White River Junction VA Medical Center | White River Junction | Vermont | 05009 | United States |
| University of British Columbia | Vancouver | British Columbia | V5Z 1M9 | Canada |
| University Medical Centre Ljubljana | Ljubljana | 1000 | Slovenia |
| 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. |
| 33130101 | 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. |
| 37414440 | 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. |
| 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. |
| 30620947 | 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. |
| 32891621 | 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. |
| 38750975 | 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. |
| 37156511 | 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. |
| 37185655 | 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. |
| 24671869 | 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. |
| 40393701 | 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. |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D003111 | Colonic Polyps |
| D000236 | Adenoma |
| D009364 | Neoplasm Recurrence, Local |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D020969 | Disease Attributes |
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