Kidney Cancer
Conditions
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.
Interventions
PROCEDURERobotic 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)
Sponsors
Regina Elena Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized trial on surgical techniques used in clinical practice, relating to patients with organ-confined renal tumors who are candidates for OCRPN surgery, designed with the aim of prospectively demonstrating that SL-ocRPN is not inferior to RR-ocRPN in terms of surgical results (expressed by the Trifecta rate)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Direct costs | 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. |
Countries
Italy
Outcome results
None listed