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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
546
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.
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.
Indiana University
Indianapolis, Indiana, United States
Rate of recurrence
Rate of recurrence will be assessed by identification of recurrent polyp tissue at the follow-up procedure.
Time frame: 1 day
Time of endoscopic management of recurrent polyp
The time it takes to treat recurrent polyp at the follow-up procedure
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Perceived difficulty of endoscopic treatment of recurrent polyp
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Rate of high grade dysplasia identified in recurrent polyp
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The rate of high grade dysplasia identified in recurrent polyp tissue.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months