RecruitingNot ApplicableNCT07190638

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

Sponsor

Brazilian Institute of Robotic Surgery

Enrollment

80 participants

Start Date

Jul 23, 2025

Study Type

INTERVENTIONAL

Conditions

RCC, Renal Cell Cancer

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

Min Age: 18 Years

Inclusion Criteria8

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 Criteria7

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

Interventions

PROCEDUREMedullary-only suturing (single-layer)

Only the base layer (medulla) is sutured after tumor excision, Cortical suturing is omitted. Hemostatic agents are applied.

DEVICESuture

Synthetic absorbable monofilament suture (Caproyl™ 3-0).

PROCEDUREMedullary and cortical suturing (two-layer)

Both medullary and cortical layers are sutured after tumor excision, Performed with robotic assistance using absorbable sutures. Hemostatic agents are applied

DEVICESuture

Synthetic absorbable monofilament suture (Caproyl™ 3-0), absorbable braided suture (Vicryl™ 0)

DEVICEHemostatic Agent

Hemostatic agents (e.g., Bleed Stp Plus, Surgicel® Fibrillar, Hemopatch®).