Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrazilian Institute of Robotic Surgery

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Medullary-only suturing (single-layer)
  • Suture
  • Medullary and cortical suturing (two-layer)
  • Suture
  • Hemostatic Agent

Treatment groups

80 Participants
are divided into 2 treatment groups