Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial, From 2025 to 2027

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Brazil
Brazilian Institute of Robotic Surgery
RECRUITING
Salvador
Hospital MaterDei Salvador
RECRUITING
Salvador
Contact Information
Primary
Nilo J Leão, MD.
ibcrpesquisa@gmail.com
+55 71 2626-3030
Backup
Felipe P Albuquerque, MD.
fpinhoalbuquerque@gmail.com
+55 71 99733-3330
Time Frame
Start Date: 2025-07-23
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 80
Treatments
Experimental: Medullary-only suturing (single-layer)
After partial nephrectomy, only the medullary layer is sutured using a running 3-0 synthetic absorbable monofilament suture (Caproyl™). The cortical layer is not sutured. Hemostatic agents, such as Bleed Stp Plus, Surgicel® Fibrillar, or Hemopatch®, may be applied to support hemostasis.
Active_comparator: Medullary and cortical suturing (two-layer)
After partial nephrectomy, both the medullary and cortical layers are sutured. The medullary layer is closed with a running 3-0 Caproyl™ suture before unclamping. Then, the cortical layer is sutured with 0 Vicryl™ using a running technique. Hemostatic agents, such as Bleed Stp Plus, Surgicel® Fibrillar, or Hemopatch®, may be applied to assist in bleeding control.
Related Therapeutic Areas
Sponsors
Leads: Brazilian Institute of Robotic Surgery

This content was sourced from clinicaltrials.gov