20.500.12556/DiRROS-30681 Recommendations to standardize the conduct of clinical trials evaluating novel therapies for perianal fistulizing Crohn’s disease Background and Aims: Perianal fistulizing Crohn’s disease (PFCD) is a potentially debilitating condition with few systematically evaluated treatment options. We aimed to develop expert recommendations to standardize study design and conduct of randomized controlled trials (RCTs) of medical therapy for patients with PFCD. Methods: We utilized a RAND/UCLA appropriateness method to develop a framework for conducting RCTs of medical therapy in PFCD. An expert international panel of 15 gastroenterologists, radiologists, and colorectal surgeons rated the appropriateness of survey statements in two rounds of voting. Median scores of 1 to ≤3.5, >3.5 to <6.5 and ≥6.5 to 9 on survey statements reflected panel ratings of inappropriate, uncertain, and appropriate, respectively. Results: A total of 292 statements were rated in the final survey, of which 156 (53.4%) were considered appropriate and formed the basis for recommendations. Trial eligibility should be decided based on both clinical and radiological criteria and patients should exhibit a minimum degree of clinical disease activity at screening. The primary efficacy outcome should be either a co-primary or composite of clinical and radiological assessments depending on treatment phase (induction vs maintenance) recognizing that clinical endpoints are meaningful for patients and radiological outcomes are essential to objectively capture the burden of disease. There was uncertainty regarding definition of radiological remission, but presence of a perianal fluid collection of any size was considered inconsistent with radiologic remission. Conclusions: These recommendations may help to standardize study design and conduct and foster clinical development of much needed therapies for this debilitating manifestation of CD. inflammatory bowel disease perianal fistula Crohn's disease kronične vnetne črevesne bolezni perianalna fistula Crohnova bolezen true false true Angleški jezik Slovenski jezik Neznano 2026-07-01 09:53:32 2026-07-01 09:53:33 2026-07-02 03:59:39 0000-00-00 00:00:00 2026 0 0 Nasl. z nasl. zaslona; Opis vira z dne 24. 11. 2025; str. 1928-1937 iss. 7 Vol. 24 2026 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 616.3 1542-7714 10.1016/j.cgh.2025.11.005 258359043 RAZ_Vuyyuru_Sudheer_Kumar_2026.pdf RAZ_Vuyyuru_Sudheer_Kumar_2026.pdf 1 C8A82B276B4DA0C418329C9776FC909C 137b87b94fcaa54cea8a61db872d43e843e5f26c01379432157f0ac86bef3031 0c780295-7522-11f1-b0d9-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=46740 https://www.cghjournal.org/article/S1542-3565(25)00988-7/fulltext 1 f65281c4-7521-11f1-b0d9-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=46738 Univerzitetni klinični center Ljubljana 0 0 0