Actively Recruiting
Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial
Led by Brazilian Institute of Robotic Surgery · Updated on 2025-09-24
80
Participants Needed
2
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of renal mass confirmed by computed tomography (CT) or magnetic resonance imaging (MRI)
- Indication for partial nephrectomy
- Written informed consent
- Expected survival of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or less
- Negative serum or urine pregnancy test within 24 hours before surgery for women of childbearing potential
- Recovery from any prior therapy-related toxicity to grade 1 or better
- If biopsy performed, pathology consistent with renal cell carcinoma (RCC)
You will not qualify if you...
- Solitary kidney
- Multiple or bilateral renal masses if more than one mass operated on simultaneously or within less than 4 months
- Hepatic or renal toxicity grade 2 or higher with glomerular filtration rate (GFR) less than 30
- Bleeding diathesis (bleeding disorder)
- Inability to maintain anticoagulation for surgery
- Participation in another experimental trial simultaneously or within 30 days prior to enrollment
- Significant acute or chronic medical, neurological, or psychiatric condition that could compromise safety or study completion in the opinion of the Principal Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hospital MaterDei Salvador
Salvador, Estado de Bahia, Brazil, 40220-005
Actively Recruiting
2
Brazilian Institute of Robotic Surgery
Salvador, Estado de Bahia, Brazil, 43017030
Actively Recruiting
Research Team
N
Nilo J Leão, MD.
CONTACT
F
Felipe P Albuquerque, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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