Randomized Clinical Trial Aimed at Comparing Unclamped Robotic Partial Nephrectomy With or Without Renorrhaphy

N/AActive Not RecruitingNCT06846112

Regina Elena Cancer Institute248 enrolled

Overview

Intended to minimize ischemia during robotic partial nephrectomy (RPN) procedures "by any means possible". Before starting enucleation, the boundaries of the tumor are marked during SL-ocRPN surgery cautery. Once the tumor is removed, the resection bed is cauterized by dispensing monopolar energy with "quasi-contact" mode, and hemostasis is progressively improved.

Since RR impacts postoperative renal function, we believe the use of cautery instead of suture of the parenchymal breach after tumor enucleation provides at least postoperative functional results not lower, shorten the intervention time and reduce the direct costs associated with the procedure. Based on available pilot studies, SL-ocRPN is safe, fast, and both the transfusion rate and duration of the hospital stay are not affected by the lack of renorrhaphy at the end of the enucleation. At the same time, this surgical approach does not require the use of a robotic needle holder and this can result in a reduction of direct costs related to treatment. Furthermore, based on the preliminary data available, the rate of positive surgical margins would also not result influenced by the absence of RR and the risk of local recurrence could even be reduced by the extended one coagulation of the tumor bed after enucleation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

248

Conditions

Kidney Cancer

Interventions

Robotic partial nephrectomyPROCEDURE

Robotic partial nephrectomy (RPN) is the treatment of choice for organ-confined renal tumors. For to improve functional outcomes, we designed an off-clamp and suture-free approach (SL) to limit the ischemic damage and destruction of the renal parenchyma caused, respectively, by temporary closure of the vessels of the renal hilum and by renorrhaphy (RR) (i.e. by the juxtaposition of the margins of resection of the enucleation bed, which is commonly performed at the end of tumor exeresis using suture threads stopped by surgical clips)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age ≥ 18 years; * radiological diagnosis of organ-confined renal neoplasm (cT1-2 cN0); * patient who is a candidate, due to personal or tumor characteristics, for ocRPN intervention; * compliant patient, able to follow the procedures/follow-up; * patient who agrees to participate in the clinical study and the planned randomization, by signing the informed consent. Exclusion Criteria: * preoperative evidence of unilateral/bilateral synchronous renal neoplasms; * personal history of renal surgery for benign or malignant pathology.

Locations (1)

"Regina Elena" National Cancer Institute

Rome, Rome, Italy

Outcomes

Primary Outcomes

Trifecta rate

The Trifecta rate \[defined as negative surgical margins, no major complications, no \>30% glomerular filtration rate reduction\] will be assessed and used to compare outcomes in the 2 arms. Then prospectively demonstrate that sutureless (SL) ocRPN is non-inferior to RR ocRPN in terms of surgical outcome.

Time frame: 36 months

Data from ClinicalTrials.gov

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