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RECRUITING
NCT07190638
NA

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

Sponsor: Brazilian Institute of Robotic Surgery

View on ClinicalTrials.gov

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.

Official title: Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial, From 2025 to 2027

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-07-23

Completion Date

2027-05-31

Last Updated

2025-09-24

Healthy Volunteers

No

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®).

Locations (2)

Hospital MaterDei Salvador

Salvador, Estado de Bahia, Brazil

Brazilian Institute of Robotic Surgery

Salvador, Estado de Bahia, Brazil