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Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial
Sponsor: Brazilian Institute of Robotic Surgery
Summary
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.
Official title: Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial, From 2025 to 2027
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-07-23
Completion Date
2027-05-31
Last Updated
2025-09-24
Healthy Volunteers
No
Conditions
Interventions
Medullary-only suturing (single-layer)
Only the base layer (medulla) is sutured after tumor excision, Cortical suturing is omitted. Hemostatic agents are applied.
Suture
Synthetic absorbable monofilament suture (Caproyl™ 3-0).
Medullary and cortical suturing (two-layer)
Both medullary and cortical layers are sutured after tumor excision, Performed with robotic assistance using absorbable sutures. Hemostatic agents are applied
Suture
Synthetic absorbable monofilament suture (Caproyl™ 3-0), absorbable braided suture (Vicryl™ 0)
Hemostatic Agent
Hemostatic agents (e.g., Bleed Stp Plus, Surgicel® Fibrillar, Hemopatch®).
Locations (2)
Hospital MaterDei Salvador
Salvador, Estado de Bahia, Brazil
Brazilian Institute of Robotic Surgery
Salvador, Estado de Bahia, Brazil