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

Last updated: December 16, 2025
Sponsor: Regina Elena Cancer Institute
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Renal Cell Carcinoma

Kidney Cancer

Urothelial Tract Cancer

Treatment

Robotic partial nephrectomy

Clinical Study ID

NCT06846112
RS1835/23
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ocRPNintervention;

  • compliant patient, able to follow the procedures/follow-up;

  • patient who agrees to participate in the clinical study and the plannedrandomization, by signing the informed consent.

Exclusion

Exclusion Criteria:

  • preoperative evidence of unilateral/bilateral synchronous renal neoplasms;

  • personal history of renal surgery for benign or malignant pathology.

Study Design

Total Participants: 248
Treatment Group(s): 1
Primary Treatment: Robotic partial nephrectomy
Phase:
Study Start date:
July 07, 2023
Estimated Completion Date:
July 07, 2028

Study 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.

Connect with a study center

  • "Regina Elena" National Cancer Institute

    Rome 3169070, Rome 00144
    Italy

    Site Not Available

  • "Regina Elena" National Cancer Institute

    Rome, 00144
    Italy

    Site Not Available

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