Cortical-plus-medullary versus medullary-only suturing for robot-assisted partial nephrectomy
Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial, From 2025 to 2027
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brazilian Institute of Robotic Surgery Academic / other |
| Locations | 2 sites (Salvador, Estado de Bahia and 1 other locations) |
| Trial ID | NCT07190638 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Salvador, Estado de Bahia and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.