Clinical trial NCT06846112: Randomized Clinical Trial Aimed at Comparing Unclamped Robotic Partial Nephrectomy With or Without Renorrhaphy
Official title: Randomized Clinical Trial Aimed at Comparing Unclamped Robotic Partial Nephrectomy With or Without Renorrhaphy. Randomized Control Trial Comparing Off-clamp Robotic Partial Nephrectomy With or Without Renorrhaphy. Project: GR-2021-12373396
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Cancer
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized trial on surgical techniques used in clinical practice, relating to patients with organ-confined renal tumors who are candidates for OCRPN surgery, designed with the aim of prospectively demonstrating that SL-ocRPN is not inferior to RR-ocRPN in terms of surgical results (expressed by the Trifecta rate)
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Trifecta rate
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
measure: Direct costs
timeFrame: 36 months
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
affiliation: IRCCS "Regina Elena" National Cancer Institute
name: Aldo Brassetti, Doctor
role: PRINCIPAL_INVESTIGATOR
References: