The Non Invasive Post Polypoectomy Surveillance Study (NIPPSS) - Project Summary After removal of colorectal polyps (polypectomy), surveillance colonoscopy, such as a three-year follow-up after advanced polyp removal, is routinely recommended. However, surveillance colonoscopy is associated with several challenges. The strategy is expensive, invasive, and associated with rare but significant risks. Colorectal cancer (CRC) may occur early in the surveillance window, before colonoscopy is due, leading to delayed diagnosis. Participation in surveillance colonoscopy is suboptimal, and as low as 21% for those with advanced polyps. A complementary strategy that is both more frequent and more acceptable--most feasibly done with non-invasive tests--is required to meet these challenges. One such strategy is fecal testing, such as with the fecal immunochemical test (FIT), which is recommended annually for average risk screening. Available evidence suggests a strategy of surveillance FIT is a promising new surveillance paradigm but requires formal investigation via prospective trials. Our overarching goal is to develop and evaluate a non- invasive, evidence-based strategy for post-polypectomy surveillance that maximizes participation and detection while minimizing patient burden and system strain. Accordingly, we propose the following Specific Aims across two project phases (UG3 pilot and UH3 pragmatic randomized controlled trial): (1) UG3 Aim 1: Pilot and optimize a surveillance FIT strategy to inform the UH3 trial design. Findings will inform FIT thresholds, projected number of colonoscopies, follow-up, sample size, and other statistical considerations, for the final UH3 protocol; (2) UG3 Aim 2: Refine the surveillance FIT protocol using participant and clinician input. Input will include barriers and facilitators to participation and approach to optimizing recruitment and adherence to inform the final UH3 trial protocol; (3) UH3 Aim 1: Compare surveillance FIT to usual-care colonoscopy for advanced neoplasia detection among patients with prior advanced polyps. We will randomize 2,422 patients 1:1 to three-year colonoscopy vs. annual FIT with immediate colonoscopy for abnormal results. We hypothesize that an annual surveillance FIT strategy is non-inferior to usual care colonoscopy surveillance, with no more than an absolute 3% difference in advanced neoplasia detection at three years (primary outcome); (4) UH3 Aim 2: Assess acceptability, barriers, and facilitators for implementation of surveillance FIT.. We will interview patients, primary care clinicians, gastroenterology specialists, and guideline experts on barriers, facilitators, and implementation strategies for the novel surveillance FIT paradigm. The proposed study is well positioned to test whether a non-invasive strategy for post-polypectomy surveillance, can be used as an alternative to the current invasive surveillance colonoscopy paradigm, which has not changed in over 30 years, and thereby impact clinical practice.
