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

Not Applicable

Recruiting

• Conditions: Kidney Cancer

• Registration Number: NCT06846112
• Lead Sponsor: Regina Elena Cancer Institute

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.

Study Timeline

• Study Start: 2023-07-07
• Study First Submitted: 2024-03-06
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-07-07
• Study Completion: 2028-07-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 248

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Trifecta rate	36 months	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.

Trial Locations

Locations (1)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy