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

NCT ID: NCT06846112

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-07
• Study Completion Date: 2028-07-07

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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

RR-ocRPN

Subjects assigned to group A will receive surgical treatment through robotic partial nephrectomy (RPN), through an off-clamp and sutureless approach (SL)

Group Type: EXPERIMENTAL

Robotic partial nephrectomy

Intervention Type: PROCEDURE

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)

SL-ocRPN

Subjects assigned to group B will receive surgical treatment of robotic partial nephrectomy (RPN), through temporary closure of the renal hilar vessels and renorrhaphy (RR), i.e. by juxtaposing the resection margins of the enucleation bed

Group Type: ACTIVE_COMPARATOR

Robotic partial nephrectomy

Intervention Type: PROCEDURE

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)

Interventions

Robotic partial nephrectomy

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)

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regina Elena Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aldo Brassetti, Doctor

Role: PRINCIPAL_INVESTIGATOR

IRCCS "Regina Elena" National Cancer Institute

Locations

"Regina Elena" National Cancer Institute

Rome, Rome, Italy

Countries

Italy

Other Identifiers

RS1835/23

Identifier Type: -

Identifier Source: org_study_id