protocolSection identificationModule nctId: NCT06324838, orgStudyIdInfo id: 248-2021-NQ, briefTitle: Extended Mesenteric Resection in Ileocecal Crohn's Disease., acronym: EXCEED, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-06, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, descriptionModule briefSummary: The EXCEED project aims to study the role of the mesentery in disease recurrence in Crohn's disease (CD), as evidence suggests that including the mesentery when doing ileocecal resections can significantly reduce recurrence rates. The EXCEED study is a blinded randomised clinical trial with 204 participants having ileocecal Crohn's disease requiring resection. Participants will undergo either "standard" mesocolic sparing resection or extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site. The primary endpoint is endoscopic recurrence 12 months postoperatively.Additionally, the study aims to evaluate the efficacy of different surveillance modalities in detecting anastomotic site recurrence. These examinations will be conducted pre- and postoperatively for a cohort of 20 participants.Through this study, we seek to understand the mesentery's role in Crohn's disease recurrence and identify effective non-invasive methods for postoperative monitoring., conditionsModule conditions: Crohn's Disease of Terminal Ileum, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Blinded multicenter randomized controlled clinical trial (RCT)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: This randomized controlled trial will incorporate blinding procedures, with the understanding that due to the nature of this interventional surgical study, the operating surgeon cannot be blinded. However, rigorous measures will be implemented to ensure blinding of both patients and all other participants involved in patient treatment. The description of the surgery within the patient chart will follow a standardized format, with the exception of the resection details. Where the two treatment methods diverge, a predefined, standardized text referencing the study will be inserted., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 204, type: ESTIMATED, armsInterventionsModule interventions name: Standard laparoscopic ileocecal resection, interventions name: Extended laparoscopic ileocecal resection, outcomesModule primaryOutcomes measure: Endoscopic recurrence, secondaryOutcomes measure: Early endoscopic recurrence, secondaryOutcomes measure: Clinical signs of recurrence / morbidity., secondaryOutcomes measure: Difference in disease severity, secondaryOutcomes measure: Patient reported outcome 1, secondaryOutcomes measure: Patient reported outcome 2, secondaryOutcomes measure: Reoperations, secondaryOutcomes measure: Perioperative complications, secondaryOutcomes measure: Cost of treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False