NCT07190638Recruiting
Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial
Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial, From 2025 to 2027
Source: ClinicalTrials.gov · Last updated 24 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 25 Jul 2025
- Start date
- 23 Jul 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Brazilian Institute of Robotic Surgery
- Diseases
- Kidney cancer
- NCT number
- NCT07190638
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 23 Jul 2025 to the primary completion date, 31 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to maintain anticoagulation for surgery
- Participation in another experimental trial simultaneously or within 30 days prior to enrollment
Other illness
- Bleeding diathesis
- 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
Lab values
- Hepatic or renal toxicity grade ≥ 2 with glomerular filtration rate (GFR) \< 30 according to Common Terminology Criteria for Adverse Events (CTCAE v4)
Other
- Solitary kidney
- Multiple or bilateral renal masses if more than one mass is operated on simultaneously or within less than 4 months
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital MaterDei Salvador Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Brazilian Institute of Robotic Surgery Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.