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

NCT07190638 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-24

No results posted yet for this study

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.

Conditions

  • RCC, Renal Cell Cancer

Interventions

PROCEDURE

Medullary-only suturing (single-layer)

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

DEVICE

Suture

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

PROCEDURE

Medullary 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

DEVICE

Suture

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

DEVICE

Hemostatic Agent

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

Sponsors & Collaborators

  • Brazilian Institute of Robotic Surgery

    lead OTHER

Principal Investigators

  • Nilo J Leão, MD. · Brazilian Institute of Robotic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-23
Primary Completion
2027-03-31
Completion
2027-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07190638 on ClinicalTrials.gov