[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645243":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":25,"responsibleParty":49,"collaborators":18,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":18,"enrollmentInfo":62,"targetDuration":18,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":28,"whyStopped":18,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IOUS-guided margin selection \"Margin B\"","EXPERIMENTAL","After the surgeon initially selects the macroscopic Margin A, IOUS will be performed to guide the selection of a proximal resection margin (\"Margin B\"). Margin B will be defined by specific IOUS criteria: mural thickness ≤ 2.5 mm and preserved stratification of the bowel wall.",[13],"Device: IOUS-guided margin selection",{"label":15,"type":16,"description":17,"interventionNames":18},"Macroscopic margin selection \"Margin A\"","NO_INTERVENTION","The proximal transection site of the ileocecal resection will be chosen by the surgeon based on gross visual and tactile assessment of the bowel (\"Margin A\"). This represents the current standard of care.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","IOUS-guided margin selection","Intra-operative ultrasound (IOUS)-guided proximal resection margin selection during ileocolic resection for terminal ileal Crohn's disease",[9],[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Cleveland Clinic","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-81.69541,41.4995,{"lat":38,"lon":37},[41,46],{"name":42,"role":43,"phone":44,"phoneExt":18,"email":45},"Monica Branche","CONTACT","216-445-6570","BRANCHM2@ccf.org",{"name":47,"role":48,"phone":18,"phoneExt":18,"email":18},"Anthony de Buck van Overstraeten, MD","PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Anthony de Buck van Overstraeten","Visiting Associate Professor","100645243","ultrasound-guided-versus-standard-margin-selection-in-ileocecal-resection-of-terminal-ileal-cd-100645243",false,"NCT07680283","Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD","Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal Crohn's Disease: A Phase II Randomized Trial","SMILE-CD","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Diagnosis of terminal ileal Crohn's disease with inflammatory or fibrostenotic phenotype localized to terminal ileum\u002Fileocecal region and assessed on either preoperative imaging or during surgical exploration at the time of surgery.\n* Scheduled to undergo primary ileocolic resection.\n\nExclusion Criteria:\n\n* Penetrating disease with abscess or complex fistula requiring complex resection.\n* Prior ileocolic resection.\n* Diagnosis of Crohn's colitis.\n* Pregnancy or inability to provide informed consent.\n* Stoma at or before randomization: Participants in whom a stoma is required before randomization (identified intra-operatively) will not be randomized and will be excluded from the trial. Stoma after randomization: If a stoma is created after randomization-either during the index operation or at re-operation for postoperative complications-the participant remains in the trial. All feasibility, histopathology, operative, and safety outcomes will be collected and analyzed in the assigned arm (ITT). However, these participants will not be evaluable for the endoscopic-recurrence endpoint; they will be listed as \"not assessed for endoscopic recurrence (stoma)\" with reasons documented.\n* Contraindication to IOUS (as determined by the surgeon).","ALL","18 Years",{"count":63,"type":64},44,"ESTIMATED","INTERVENTIONAL",[67],"NA","This is a Phase II, single-center (Cleveland Clinic), two-arm, randomized, parallel-group superiority trial. The two arms will compare IOUS-guided margin selection against standard macroscopic margin selection in patients undergoing ileocolic resection for terminal ileal Crohn's disease. Patients and outcome assessors (pathologists, endoscopists) will be blinded to the intervention arm, while surgeons, by the nature of the intervention, cannot be blinded. Randomization will be computer-generated with concealed allocation using permuted blocks to ensure balanced group sizes.",[70],"Crohn's Disease (CD)",[72,73,74,75,76,77],"Ultrasound","ileocecal resection","anastomosis","resection margin","ileocolic resection","Crohn's disease","2026-06-29",{"date":80,"type":81},"2026-07-02","ACTUAL",{"date":83,"type":64},"2026-07",{"date":85,"type":64},"2029-01",{"name":5,"class":6},1]