[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658100":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":44,"armGroups":45,"interventions":51,"overallOfficials":40,"centralContacts":57,"locations":40,"responsibleParty":66,"collaborators":70,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":40,"enrollmentInfo":104,"targetDuration":107,"studyType":108,"phases":40,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":120,"whyStopped":40,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":40},{"fullName":5,"class":6},"Fundació d'investigació Sanitària de les Illes Balears","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Complete or Incomplete D3L","Validation of Anatomopathological Criteria for Quality Assessment: to validate, through a multicenter study, the effectiveness of new anatomopathological criteria for right hemicolectomy with D3 lymphadenectomy (D3L) in accurately classifying surgical specimens as complete or incomplete D3L.","From enrollment to the end of treatment at 8 weeks",[14,18,21,25,29,33,37],{"measure":15,"description":16,"timeFrame":17},"Total Number of Lymph Nodes Retrieved","To evaluate the total number of lymph nodes retrieved following D3 lymphadenectomy Unit of Measure: Number of lymph nodes","From enrollment to the end of treatment at 8 weeks\"",{"measure":19,"description":20,"timeFrame":12},"Positive Lymph Nodes Retrieved from the D3 Lymphadenectomy Area","To determine the presence and number of positive lymph nodes within the D3 lymphadenectomy area.\n\nUnit of Measure: Number of positive lymph nodes",{"measure":22,"description":23,"timeFrame":24},"Perioperative Complications","To assess the incidence and severity of perioperative complications following right hemicolectomy with D3 lymphadenectomy, according to the Clavien-Dindo classification.","From enrollment to the end of treatment at 30 days.",{"measure":26,"description":27,"timeFrame":28},"Local Recurrence","To assess the rate of local recurrence following right hemicolectomy with D3 lymphadenectomy.","From enrollment to the end of treatment at 5 years",{"measure":30,"description":31,"timeFrame":32},"Systemic Recurrence","To assess the rate of systemic recurrence following right hemicolectomy with D3 lymphadenectomy.","From enrollment to 5 years",{"measure":34,"description":35,"timeFrame":36},"Three-Year Overall Survival","To assess overall survival at 3 years following right hemicolectomy with D3 lymphadenectomy.","From enrollment to 3 years",{"measure":38,"description":39,"timeFrame":32},"Five-Year Overall Survival","To assess overall survival at 5 years following right hemicolectomy with D3 lymphadenectomy.",null,{"allocation":40,"interventionModel":40,"interventionModelDescription":40,"primaryPurpose":40,"observationalModel":42,"timePerspective":43,"maskingInfo":40},"COHORT","PROSPECTIVE","Patients diagnosed of right colon neoplams undergoing elective or emergency surgery.",[46],{"label":47,"type":40,"description":48,"interventionNames":49},"Patients with right colon neoplasm","pPtients over 18 years of age undergoing either elective or emergency surgery with a diagnosis of adenocarcinoma or adenoma with dysplasia located in the cecum, ascending colon, or hepatic flexure of the colon.",[50],"Procedure: Right Colectomy & D3 Lymphadenectomy",[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":40},"PROCEDURE","Right Colectomy & D3 Lymphadenectomy","Patients enrolled would receive a right colectomy with dissection of the Lymphoadipose tissue over the superior mesenteric vein, including all the tissue from the ileocolic vessels to the superior right colic vein.",[47],[58,63],{"name":59,"role":60,"phone":61,"phoneExt":40,"email":62},"Álvaro García-Granero, MD, PhD","CONTACT","+34871205000","alvaro.garciagranero@ssib.es",{"name":64,"role":60,"phone":61,"phoneExt":40,"email":65},"Sebastian Jeri, MD, PhD","sebastian.jeri@ssib.es",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Sebastian Jeri","MD, MSc, PhD",[71,74,76,78,80,82,84,87,89,91,93],{"name":72,"class":73},"Hospital Universitari de Bellvitge","OTHER",{"name":75,"class":73},"Hospital Universitario La Fe",{"name":77,"class":73},"Hospital Universitario Marqués de Valdecilla",{"name":79,"class":73},"Hospital Universitari Vall d'Hebron Research Institute",{"name":81,"class":73},"Hospital General Universitario Gregorio Marañon",{"name":83,"class":73},"Hospital Universitario Ramon y Cajal",{"name":85,"class":86},"University Hospital of Girona Dr. Josep Trueta","NETWORK",{"name":88,"class":73},"Hospital General Universitario Reina Sofía de Murcia",{"name":90,"class":73},"Hospital del Mar",{"name":92,"class":73},"Hospital Son Espases",{"name":94,"class":73},"Hospital Álvaro Cunqueiro","100658100","multicenter-prospective-study-protocol-for-validating-surgical-quality-standards-in-d3-lymphadenectomy-for-oncological-right-hemicolectomy-100658100",false,"NCT07847216","Multicenter Prospective Study Protocol for Validating Surgical Quality Standards in D3 Lymphadenectomy for Oncological Right Hemicolectomy","D3L","Inclusion Criteria:\n\n* The study includes consecuent patients undergoing either elective or emergency surgery with a diagnosis of adenocarcinoma or adenoma with dysplasia located in the cecum, ascending colon, or hepatic flexure of the colon.\n\nExclusion Criteria:\n\n* Patients under 18 years of age or lack of informed consent for inclusion in the study.","ALL","18 Years",{"count":105,"type":106},120,"ESTIMATED","5 Years","OBSERVATIONAL","Introduction: D3 lymphadenectomy (D3L) for right hemicolectomy, proposed by Eastern guidelines, aims to improve oncological outcomes by extending resection to include lymphatic drainage zones beyond those addressed by complete mesocolic excision (CME). However, the absence of standardized anatomopathological quality parameters limits its validation. This multicenter study seeks to validate this criteria, including the \"right mesocolic sail,\" to classify D3L specimens and evaluate its clinical and oncological implications.\n\nMaterials and Methods: This prospective, multicenter study involves 11 hospitals in Spain. Surgical specimens from right hemicolectomy with D3L will be analyzed for the presence of the \"right mesocolic sail\" and classified as complete or incomplete D3L. Standard CME criteria will also be applied. Patient data, surgical details, and oncological outcomes at 3 and 5 years will be collected. Statistical analysis will compare lymph node retrieval, recurrence rates, survival outcomes, and perioperative complications between groups.\n\nResults: The study will validate the right mesocolic sail as a quality parameter for D3L. Preliminary data from prior phases confirm increased lymph node retrieval and the presence of positive nodes in D3L specimens. Additional analyses will determine the impact of D3L on recurrence rates, survival, and perioperative risks.\n\nDiscussion: This study aims to provide standardized anatomopathological criteria to evaluate D3L, facilitating comparative studies and addressing its controversial oncological benefits. If validated, the criteria could enhance surgical quality assessment and inform future guidelines.",[111,112,113],"Colon Neoplasms","Right Colon Tumors","Lymphadenectomy",[115,116,117,118,119],"Colon neoplasm","D3 lymph node excision","Oncological outcomes","Pathology quality","Multicenter study","NOT_YET_RECRUITING","2026-09-29",{"date":123,"type":124},"2026-10-02","ACTUAL",{"date":126,"type":106},"2026-09-01",{"date":128,"type":106},"2031-09-30",{"name":5,"class":6}]