Cortical-plus-medullary versus medullary-only suturing for robot-assisted partial nephrectomy
Official title: Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial, From 2025 to 2027
Run by Brazilian Institute of Robotic Surgery · NCT07190638 · Data updated 2026-11-12
This trial tests whether using only medullary stitches instead of both medullary and cortical stitches during robot-assisted partial nephrectomy helps protect kidney function and reduce operative time and blood loss for people with localized renal cell carcinoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Brazilian Institute of Robotic Surgery Academic / other |
| Locations | 2 sites (Salvador, Estado de Bahia and 1 other locations) |
| Status | Recruiting |
| Started | July 23, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | September 24, 2025 |
| Trial ID | NCT07190638 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with a localized renal mass who are scheduled for robot-assisted partial nephrectomy, have ECOG performance status 0–1, and can provide informed consent.
✕Probably not a fit
Patients with a solitary kidney, severe baseline renal failure (GFR <30), multiple/bilateral tumors requiring multiple procedures, or uncorrectable bleeding disorders are unlikely to benefit from the medullary-only approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial assigns patients undergoing robot-assisted partial nephrectomy to either a single-layer medullary-only renorrhaphy or a standard two-layer cortical-plus-medullary repair. Primary outcomes include postoperative renal function, operative time, blood loss, and surgical complications, with follow-up measures to track renal function preservation. Eligible patients have localized renal masses suitable for partial nephrectomy, ECOG ≤1, and adequate baseline kidney function, while key exclusions include solitary kidney, multiple simultaneous tumors, severe renal impairment (GFR <30), or bleeding diathesis. All procedures are performed at Hospital MaterDei Salvador in Salvador, Brazil, by surgeons experienced in robot-assisted nephron-sparing surgery.
Why it matters
Potential benefit: If successful, the medullary-only approach could preserve more kidney function while shortening surgery time and reducing blood loss.
How similar studies have gone: Several small observational series and retrospective comparisons suggest omitting cortical sutures may reduce ischemic injury, blood loss, and operative time, but randomized prospective data are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
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Hospital MaterDei Salvador
Salvador, Estado de Bahia, Brazil Recruiting -
Brazilian Institute of Robotic Surgery
Salvador, Estado de Bahia, Brazil Recruiting
Study contacts
- Principal investigator: Nilo J Leão, MD. — Brazilian Institute of Robotic Surgery
- Study coordinator: Nilo J Leão, MD.
- Email: ibcrpesquisa@gmail.com
- Phone: +55 71 2626-3030
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.