Status:
RECRUITING
Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial
Lead Sponsor:
Brazilian Institute of Robotic Surgery
Conditions:
RCC, Renal Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 o...
Detailed Description
To investigate the clinical impact of a potentially modifiable surgical variable, namely, the choice of suture technique during renal reconstruction, on patient outcomes following robot-assisted parti...
Eligibility Criteria
Inclusion
- 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) score performance status ≤ 1
- 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 a biopsy has been performed, pathology consistent with renal cell carcinoma (RCC)
Exclusion
- Solitary kidney
- Multiple or bilateral renal masses if more than one mass is operated on simultaneously or within less than 4 months
- Hepatic or renal toxicity grade ≥ 2 with glomerular filtration rate (GFR) \< 30 according to Common Terminology Criteria for Adverse Events (CTCAE v4)
- Bleeding diathesis
- 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, limit study completion, or impair study objectives in the opinion of the Principal Investigator
Key Trial Info
Start Date :
July 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07190638
Start Date
July 23 2025
End Date
May 31 2027
Last Update
September 24 2025
Active Locations (2)
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1
Hospital MaterDei Salvador
Salvador, Estado de Bahia, Brazil, 40220-005
2
Brazilian Institute of Robotic Surgery
Salvador, Estado de Bahia, Brazil, 43017030