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

Regina Elena Cancer Institute

Status: Active, not recruiting

Conditions: Kidney Cancer

Treatments: Procedure: Robotic partial nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06846112

RS1835/23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

248 participants in 2 patient groups

RR-ocRPN

Experimental group

Description:

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

Treatment:

Procedure: Robotic partial nephrectomy

SL-ocRPN

Active Comparator group

Description:

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

Treatment:

Procedure: Robotic partial nephrectomy