Adenoma, Colon Cancer, Colon Polyp, Endoscopic Resection, Recurrence, Local Neoplasm, Serrated Polyp
Conditions
Keywords
Polyp Resection, Colonoscopy, Recurrence, Surveillance Interval, Patient Experience
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.
Interventions
PROCEDURE6-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.
PROCEDURE12-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.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of recurrence | 1 day | Rate of recurrence will be assessed by identification of recurrent polyp tissue at the follow-up procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. 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. |
| 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 |
Countries
Canada, Slovenia, United States
Contacts
PRINCIPAL_INVESTIGATORJohn J Guardiola, MD
Indiana University
Outcome results
None listed