6-month follow-up
ProcedureEligible 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.
NCT Number: NCT07198945
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
University of British Columbia, Vancouver, British Columbia, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient Criteria
Polyp Criteria
Exclusion criteria
Patient Criteria
Polyp Criteria
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.
Time frame: 1 day
Rate of recurrence will be assessed by identification of recurrent polyp tissue at the follow-up procedure.
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
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 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
The rate of malignancy measured at the first follow-up colonoscopy
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
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
The number of areas of recurrent polyp tissue identified at the site of the prior large polyp
Time frame: After surveillance colonoscopy, typically 6 months to 12 months
The rate of high grade dysplasia identified in recurrent polyp tissue.
Time frame: 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
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Whether surgical intervention is needed to treat recurrent polyp tissue
Time frame: 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.
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
The different techniques that were used to treat the recurrent polyp tissue.
Time frame: 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.
Time frame: 30 days after first surveillance colonoscopy
The number of complications for each randomization arm during and after the follow-up procedure
Time frame: 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
Time frame: 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
Indiana University
Other
Six Versus Twelve Month SurveillAnce Following Resection of Nonpedunculated ColorectaL Polyps 20-50 mm IN Size Without High Grade Dysplasia (HGD)
Acronym: STARLING
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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