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.
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
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
Parallel
Medullary-only suturing (single-layer)
Procedure/SurgeryOnly the base layer (medulla) is sutured after tumor excision, Cortical suturing is omitted. Hemostatic agents are applied.
Suture
DeviceSynthetic absorbable monofilament suture (Caproyl™ 3-0).
Medullary and cortical suturing (two-layer)
Procedure/SurgeryBoth medullary and cortical layers are sutured after tumor excision, Performed with robotic assistance using absorbable sutures. Hemostatic agents are applied
Suture
DeviceSynthetic absorbable monofilament suture (Caproyl™ 3-0), absorbable braided suture (Vicryl™ 0)
Hemostatic Agent
DeviceHemostatic agents (e.g., Bleed Stp Plus, Surgicel® Fibrillar, Hemopatch®).
Estimated Blood loss
Estimated blood loss, assessed to compare renorrhaphy techniques (single medullary suture vs. combined medullary and cortical suture) during partial nephrectomy. The volume, recorded in milliliters, was measured using a graduated collection canister connected to the assistant surgeon's suction device, with correction for the amount of saline solution instilled into the cavity.
Change in estimated glomerular filtration rate (eGFR)
Difference in eGFR values calculated using the CKD-EPI formula between baseline (preoperative) and postoperative time points
Percentage renal volume loss
Percentage reduction in renal parenchymal volume calculated from CT scan measurements at 4 months compared with baseline preoperative volume.
Warm ischemia time
Duration, in minutes, of arterial clamping recorded during partial nephrectomy
Participants with intraoperative or postoperative complications
Number of participants experiencing complications such as hematuria, pseudoaneurysm, or urinary fistula, graded according to the Clavien-Dindo classification.
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