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Active, Not Recruiting

NCT Number: NCT06846112

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic partial nephrectomy

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)

Primary outcomes

  1. Trifecta rate

    Time frame: 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.

Other outcomes

  1. Direct costs

    Time frame: 36 months

    To prospectively compare direct costs associated with ocRPN with or without RR. For the purposes of the study, the out-of-pocket costs of the study, of the robotic instruments used, will be systematically recorded and used to estimate the direct costs associated with ocRPN with or without RR and the two surgical approaches will be compared accordingly.

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Feb 25, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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