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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 248
- Locations
- 1
- Primary Endpoint
- Trifecta rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
RR-ocRPN
Subjects assigned to group A will receive surgical treatment through robotic partial nephrectomy (RPN), through an off-clamp and sutureless approach (SL)
Intervention: Robotic partial nephrectomy (Procedure)
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
Intervention: Robotic partial nephrectomy (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported