[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541052":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":55,"studyPopulation":43,"armGroups":56,"interventions":69,"overallOfficials":81,"centralContacts":86,"locations":94,"responsibleParty":111,"collaborators":43,"id":113,"slug":43,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":43,"enrollmentInfo":122,"targetDuration":43,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":96,"whyStopped":43,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Odense University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Endoscopic recurrence","Endoscopic signs of recurrence, defined as a modified Rutgeerts score \\>i2a.","12 months postoperative",[14,17,21,25,29,32,35,39],{"measure":15,"description":11,"timeFrame":16},"Early endoscopic recurrence","6 months postoperative",{"measure":18,"description":19,"timeFrame":20},"Clinical signs of recurrence \u002F morbidity.","Resumption of medicinal treatment. Chart review will be done to identify postoperative medicinal use.","6-48 months postoperatively",{"measure":22,"description":23,"timeFrame":24},"Difference in disease severity","At the time of operation according to the Montreal classification.","Perioperative",{"measure":26,"description":27,"timeFrame":28},"Patient reported outcome 1","5Q-5D-5L","6 and 12 months postoperative",{"measure":30,"description":31,"timeFrame":28},"Patient reported outcome 2","SIBDQ",{"measure":33,"description":34,"timeFrame":28},"Reoperations","Chart review will be done to identify any reoperations due to recurrence or other complications.",{"measure":36,"description":37,"timeFrame":38},"Perioperative complications","Postoperative complications according to Clavien-Dindo classification.","30 days postoperative",{"measure":40,"description":41,"timeFrame":42},"Cost of treatment","Difference in treatment cost between the two groups. Reported in USD.","12 months postoperative.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":43,"timePerspective":43,"maskingInfo":49},"RANDOMIZED","PARALLEL","Blinded multicenter randomized controlled clinical trial (RCT).","TREATMENT",{"masking":50,"maskingDescription":51,"whoMasked":52},"DOUBLE","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.",[53,54],"PARTICIPANT","CARE_PROVIDER","Surgical Procedure and Perioperative Care Laparoscopic approach with a minimum 5 cm disease-free bowel on each side. Standard stapled side-to-side isoperistaltic anastomoses. Extended mesenteric excision involves resection of inflamed mesentery up to the level of visible inflammation.\n\nBoth treatment groups will receive standard postoperative care according to the standards of the hospital treating the participant.\n\nPostoperative Follow-up Postoperative follow-up at 6 and 12 months. This consist of an ileo-colonoscopy, chart review and questionnaires. The early follow-up at 6 months aims to detect early recurrence, enabling early medical treatment or other intervention. The 12-month follow-up will be the primary endpoint to determine recurrence. Long-term outcomes will be assessed through a chart review after 3 and 5 years, documenting reoperations, clinical symptoms, pharmacological use, and other complications.\n\nPostoperative Medicinal Use Postoperative medical prophylaxis assessment isn't explicitly detailed in the current protocol, though it will be acknowledged. Analysis will stratify participants based on pre- and post-operative biological\u002Fnon-biological treatment. The treating physician will determine postoperative medical therapy, typically maintaining pre-operative medication.\n\nPostoperative Endoscopy Endoscopy will be regarded as the golden standard for the detection of disease recurrence. The endoscopies, including bowel preparation and possible sedation, will be preformed in accordance with local guidelines at each hospital. At least three biopsies will be taken from the ileum (5 cm proximal to the anastomosis), anastomosis, and colon (5 cm below the anastomosis). A short video of each endoscopy will be saved for validation purposes. Lesions found during the endoscopy will be classified using the modified Rutgeerts score\\[7\\].\n\nPatient-Reported Outcome During the preoperative workup (baseline), the participant will be asked to complete 2 questionnaires (5Q-5D-5L and SIBDQ). Postoperatively, the participant will be asked to complete the same questionnaires at 6 and 12 months.\n\nStatistical analysis plan Outcome Analysis The investigators plan to conduct a chi-square or Fisher's exact test to compare the proportion of participants with endoscopic recurrence between the intervention and control groups.\n\nThe investigators will utilize logistic regression to adjust for potential confounding variables if needed.\n\nDemographics The Investigators will use means and standard deviations (or medians and interquartile ranges) for continuous variables. For categorical variables, frequencies and percentages will be presented and demographic characteristics between intervention and control groups will be compared.",[57,63],{"label":58,"type":59,"description":60,"interventionNames":61},"Extended mesenteric resection","EXPERIMENTAL","Arm receiving ileocecal resection with extended mesenteric resection.",[62],"Procedure: Extended laparoscopic ileocecal resection",{"label":64,"type":65,"description":66,"interventionNames":67},"Controls (Standard mesenteric resection)","ACTIVE_COMPARATOR","Arm receiving standard ileocecal resection.",[68],"Procedure: Standard laparoscopic ileocecal resection",[70,77],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"PROCEDURE","Standard laparoscopic ileocecal resection","Participants will undergo standard mesocolic sparing resection.",[64],[76],"Laparoscopic ileocecal resection",{"type":71,"name":78,"description":79,"armGroupLabels":80,"otherNames":43},"Extended laparoscopic ileocecal resection","Extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site.",[58],[82],{"name":83,"affiliation":84,"role":85},"Mark B Ellebæk, PhD","Surgical Research Unit, Odense University Hospital","STUDY_DIRECTOR",[87,92],{"name":88,"role":89,"phone":90,"phoneExt":43,"email":91},"Jens K Bælum, MD","CONTACT","+4521758114","jens.kristian.baelum@rsyd.dk",{"name":83,"role":89,"phone":43,"phoneExt":43,"email":93},"mark.ellebaek1@rsyd.dk",[95],{"facility":5,"status":96,"city":97,"state":43,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"RECRUITING","Odense","5000","Denmark","DK",{"type":102,"coordinates":103},"Point",[104,105],10.38831,55.39594,{"lat":105,"lon":104},[108],{"name":109,"role":89,"phone":110,"phoneExt":43,"email":91},"Jens Kristian Bælum, MD","+4540169388",{"type":112,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100541052",false,"NCT06324838","Extended Mesenteric Resection in Ileocecal Crohn's Disease.","Extended Mesenteric Resection in Ileocecal Crohn's Disease to Prevent Recurrent Disease - A Randomized Controlled Trial.","EXCEED","Inclusion Criteria\n\n* Patients above the age of 18 scheduled for ileocecal resection due to Crohn's disease.\n* Relevant endoscopy and imaging within the last 6 months.\n* Diagnosis of \"simple\" ileocecal Crohn's disease (limited to ileocecal disease with a maximum of 40 cm of affected ileum).\n\nExclusion Criteria\n\n* Previous ileocecal resection.\n* Inability to understand Danish or another Nordic language.\n* Inability to comprehend the purpose and design of the project.\n* Pregnancy or lactation.","ALL","18 Years",{"count":123,"type":124},204,"ESTIMATED","INTERVENTIONAL",[127],"NA","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.\n\nAdditionally, 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.\n\nThrough this study, we seek to understand the mesentery's role in Crohn's disease recurrence and identify effective non-invasive methods for postoperative monitoring.",[130],"Crohn's Disease of Terminal Ileum",[132,133],"ileocecal resection","Mesocolic resection","2026-01-13",{"date":136,"type":137},"2026-01-15","ACTUAL",{"date":139,"type":137},"2025-02-01",{"date":141,"type":124},"2029-06",{"name":5,"class":6},1]