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

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical techniques used during kidney-sparing surgery (called partial nephrectomy) for kidney tumors. Specifically, it compares a two-layer closure of the kidney versus a single inner-layer closure, looking at outcomes and surgery time. **You may be eligible if...** - You have a kidney mass seen on CT or MRI scan - You are scheduled for partial nephrectomy (surgery that removes just the tumor, not the whole kidney) - You are well enough for the procedure (ECOG 0 or 1) - You are expected to survive at least 6 months - Your biopsy (if done) is consistent with kidney cell carcinoma **You may NOT be eligible if...** - You only have one functioning kidney - You have multiple kidney tumors being operated on at the same time or within 4 months - You have severe kidney or liver dysfunction - You have a bleeding disorder or are on blood thinners that cannot be safely paused for surgery - You are already in another experimental trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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®).