Six Versus Twelve Month Surveillance Following Resection of Nonpedunculated Colorectal Polyps 20-50 mm in Size without High Grade Dysplasia (HGD)
Study on Timing of Surveillance Colonoscopy After Growth (Polyp) Removal
John Guardiola
Primary Investigator
Brief description of study
The primary objective of this study is to compare the efficacy of a standard 6-month initial surveillance colonoscopy versus a 12-month initial surveillance colonoscopy following successful removal of nonpedunculated adenomatous and sessile serrated colorectal polyps 20-50 mm in size without high grade dysplasia.
Detailed description of study
This is a randomized study of the efficacy of follow up colonoscopies after large or complex polyp resection by standard endoscopic techniques. The study will have two arms; patients will be randomized to a 6-month or 12-month initial surveillance colonoscopy after resection. The study design proposes to randomize patients who undergo resection of a nonpedunculated polyp ³ 20-50 mm in size to either a 6-month or 12-month interval for first surveillance colonoscopy. Randomization will occur after histologic diagnosis confirms conventional adenoma, (defined as tubular adenoma, tubulovillous adenoma, or villous adenoma) without HGD or sessile serrated lesion without HGD. A patient may only have one polyp included in the study. If multiple eligible polyps are found during the index colonoscopy, the largest eligible adenoma removed will be the included polyp. Enrolled patients who have eligible polyps found at their surveillance colonoscopy will not have those polyps included in the study.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Nonpedunculated adenomatous and sessile serrated colorectal polyps
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Age: 18 years - 100 years
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Gender: All
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
In order to be eligible, a polyp must meet the following criteria:
6. Size 20-50 mm as documented with photo containing open snare of known size as comparison.
7. Histology without high grade dysplasia:
a. Conventional Adenoma: adenoma with or without villous components
b. 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)
This study investigates the timing of follow-up colonoscopies after the removal of nonpedunculated colorectal polyps. These are growths in the colon that do not have a stalk and are between 20 to 50 mm in size. The purpose of this study is to see if having a follow-up colonoscopy at 6 months is as effective as having it at 12 months. The study involves two study arms: one group will have their follow-up colonoscopy at 6 months, and the other at 12 months.
In this study, participants will have had a polyp removed by standard endoscopic techniques, which means using a camera and tools through the colon to remove the polyp. Only one polyp per participant will be included, and it must be the largest one if multiple are found. The study will not include polyps that cannot be removed with these techniques or those with high grade dysplasia, which is a more serious condition.
- Who can participate: Adults aged 18 and older who can provide informed consent and are scheduled for a colonoscopy for any reason may participate. Eligible polyps must be 20-50 mm in size without high grade dysplasia.
- Study details: Participants will be randomly assigned to have their follow-up colonoscopy either 6 months or 12 months after their initial procedure. The study focuses on the effectiveness of these two timelines for follow-up after polyp removal.
