[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607598":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":47,"centralContacts":51,"locations":60,"responsibleParty":88,"collaborators":34,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":34,"enrollmentInfo":100,"targetDuration":34,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":63,"whyStopped":34,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Brazilian Institute of Robotic Surgery","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Medullary-only suturing (single-layer)","EXPERIMENTAL","After partial nephrectomy, only the medullary layer is sutured using a running 3-0 synthetic absorbable monofilament suture (Caproyl™). The cortical layer is not sutured. Hemostatic agents, such as Bleed Stp Plus, Surgicel® Fibrillar, or Hemopatch®, may be applied to support hemostasis.",[13,14,15],"Procedure: Medullary-only suturing (single-layer)","Device: Suture","Device: Hemostatic Agent",{"label":17,"type":18,"description":19,"interventionNames":20},"Medullary and cortical suturing (two-layer)","ACTIVE_COMPARATOR","After partial nephrectomy, both the medullary and cortical layers are sutured. The medullary layer is closed with a running 3-0 Caproyl™ suture before unclamping. Then, the cortical layer is sutured with 0 Vicryl™ using a running technique. Hemostatic agents, such as Bleed Stp Plus, Surgicel® Fibrillar, or Hemopatch®, may be applied to assist in bleeding control.",[21,14,15],"Procedure: Medullary and cortical suturing (two-layer)",[23,29,35,40,43],{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Only the base layer (medulla) is sutured after tumor excision, Cortical suturing is omitted. Hemostatic agents are applied.",[9],[28],"Single-layer renorrhaphy",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","Suture","Synthetic absorbable monofilament suture (Caproyl™ 3-0).",[9],null,{"type":24,"name":17,"description":36,"armGroupLabels":37,"otherNames":38},"Both medullary and cortical layers are sutured after tumor excision, Performed with robotic assistance using absorbable sutures. Hemostatic agents are applied",[17],[39],"double-layer renorrhaphy",{"type":30,"name":31,"description":41,"armGroupLabels":42,"otherNames":34},"Synthetic absorbable monofilament suture (Caproyl™ 3-0), absorbable braided suture (Vicryl™ 0)",[17],{"type":30,"name":44,"description":45,"armGroupLabels":46,"otherNames":34},"Hemostatic Agent","Hemostatic agents (e.g., Bleed Stp Plus, Surgicel® Fibrillar, Hemopatch®).",[17,9],[48],{"name":49,"affiliation":5,"role":50},"Nilo J Leão, MD.","PRINCIPAL_INVESTIGATOR",[52,56],{"name":49,"role":53,"phone":54,"phoneExt":34,"email":55},"CONTACT","+55 71 2626-3030","ibcrpesquisa@gmail.com",{"name":57,"role":53,"phone":58,"phoneExt":34,"email":59},"Felipe P Albuquerque, MD.","+55 71 99733-3330","fpinhoalbuquerque@gmail.com",[61,80],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Hospital MaterDei Salvador","RECRUITING","Salvador","Estado de Bahia","40220-005","Brazil","BR",{"type":70,"coordinates":71},"Point",[72,73],-38.49096,-12.97563,{"lat":73,"lon":72},[76],{"name":49,"role":53,"phone":77,"phoneExt":78,"email":79},"+55 (71) 3401-7129","7129","nep@materdei.com.br",{"facility":5,"status":63,"city":64,"state":65,"zip":81,"country":67,"countryCode":68,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"43017030",{"type":70,"coordinates":83},[72,73],{"lat":73,"lon":72},[86],{"name":87,"role":53,"phone":54,"phoneExt":34,"email":55},"NILO J Leão, MD",{"type":89,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100607598","comparison-of-outcomes-and-surgical-time-between-cortical-and-medullary-suture-vs-medullary-only-suture-cortex-clinical-trial-100607598",false,"NCT07190638","Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial","Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial, From 2025 to 2027","CORTEX","Inclusion Criteria:\n\n* Diagnosis of renal mass confirmed by computed tomography (CT) or magnetic resonance imaging (MRI)\n* Indication for partial nephrectomy\n* Written informed consent\n* Expected survival of at least 6 months\n* Eastern Cooperative Oncology Group (ECOG) score performance status ≤ 1\n* Negative serum or urine pregnancy test within 24 hours before surgery for women of childbearing potential\n* Recovery from any prior therapy-related toxicity to grade 1 or better\n* If a biopsy has been performed, pathology consistent with renal cell carcinoma (RCC)\n\nExclusion Criteria:\n\n* Solitary kidney\n* Multiple or bilateral renal masses if more than one mass is operated on simultaneously or within less than 4 months\n* Hepatic or renal toxicity grade ≥ 2 with glomerular filtration rate (GFR) \\\u003C 30 according to Common Terminology Criteria for Adverse Events (CTCAE v4)\n* Bleeding diathesis\n* Inability to maintain anticoagulation for surgery\n* Participation in another experimental trial simultaneously or within 30 days prior to enrollment\n* Significant acute or chronic medical, neurological, or psychiatric condition that could compromise safety, limit study completion, or impair study objectives in the opinion of the Principal Investigator","ALL","18 Years",{"count":101,"type":102},80,"ESTIMATED","INTERVENTIONAL",[105],"NA","Renal function preservation is a growing concern in the surgical management of kidney tumors, particularly with the rise in chronic kidney disease worldwide. Recent surgical innovations have focused on modifying renorrhaphy techniques to minimize renal damage. Emerging evidence suggests that omitting cortical suturing may reduce operative time, blood loss, and renal parenchymal loss without increasing major complications. This randomized controlled trial aims to compare outcomes between medullary-only and combined cortical-medullary suture techniques during robot-assisted partial nephrectomy, with the goal of identifying the approach that best balances functional preservation and surgical safety.",[108],"RCC, Renal Cell Cancer",[110,111,112,113],"Partial Nephrectomy","Robot-assisted","MEDULLARY SUTURE","MEDULLARY-ONLY SUTURE","2025-09-20",{"date":116,"type":117},"2025-09-24","ACTUAL",{"date":119,"type":117},"2025-07-23",{"date":121,"type":102},"2027-05-31",{"name":5,"class":6},2]