Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial
80 patients around the world
Available in Brazil
To investigate the clinical impact of a potentially modifiable surgical variable, namely,
the choice of suture technique during renal reconstruction, on patient outcomes following
robot-assisted partial nephrectomy.
The preservation of renal function has become a central concern in the surgical
management of renal tumors, especially given the long-term consequences of chronic kidney
disease on patient morbidity and mortality. Partial nephrectomy is preferred for
localized renal masses as it allows for oncologic control while maintaining renal
function. Traditionally, renorrhaphy involves a two-layer closure including both
medullary and cortical sutures. However, recent literature suggests that omitting the
cortical suture may reduce renal parenchymal volume loss and warm ischemia time, while
possibly introducing a higher rate of minor complications.
Despite growing interest in minimally invasive nephron-sparing techniques, robust
prospective and randomized trials directly comparing single-layer (medullary-only) and
double-layer (cortical and medullary) renorrhaphy remain scarce. The single-layer
technique, first proposed to address concerns over unnecessary cortical compression and
ischemic injury, is gaining attention for its simplicity and potential advantages in
reducing blood loss and operative time.
This trial aims to evaluate whether avoiding cortical suturing during robot-assisted
partial nephrectomy leads to improved postoperative renal function, reduced blood loss,
and shorter surgical duration. Patients will be randomly assigned to undergo either
medullary-only renorrhaphy or the conventional dual-layer approach. Both techniques will
be assessed for their effect on warm ischemia time, complication rates, renal volume
loss, and surgical efficiency.
The study will enroll 80 patients undergoing partial nephrectomy for renal masses,
distributed evenly across the two intervention groups. This sample size was calculated to
ensure statistical power to detect differences in estimated blood loss, the primary
outcome. A broad range of secondary outcomes will be measured at multiple postoperative
time points, including estimated glomerular filtration rate, renal volume, incidence of
surgical complications, and quality of life indicators.
By employing a randomized, prospective, and blinded design, the trial seeks to minimize
bias and deliver high-quality evidence to guide future surgical decision-making.
Ultimately, the study aims to clarify whether cortical renorrhaphy can be safely omitted
without compromising patient outcomes, potentially simplifying surgical technique and
improving recovery profiles in this patient population.
Brazilian Institute of Robotic Surgery
2Research sites
80Patients around the world
This study is for people with
Kidney cancer
Renal cell carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
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.
Eastern Cooperative Oncology Group (ECOG) score performance status ≤ 1.
Negative serum or urine pregnancy test within 24 hours before surgery for women of childbearing potential.
Recovery from any prior therapy-related toxicity to grade 1 or better.
If a biopsy has been performed, pathology consistent with renal cell carcinoma (RCC).
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.
Inability to maintain anticoagulation for surgery.
Participation in another experimental trial simultaneously or within 30 days prior to enrollment.
Significant acute or chronic medical, neurological, or psychiatric condition that could compromise safety, limit study completion, or impair study objectives in the opinion of the Principal Investigator.
Sites
Hospital Mater Dei Salvador
Recruiting
Av. Vasco da Gama, 6783 - Engenho Velho da Federacao, Salvador - BA, 40220-005, Brazil
IBCR - Instituto Brasileiro de Cirurgia Robótica
Recruiting
Av. Anita Garibaldi, 1815 - Federação, Salvador - BA, 40210-750, Brazil