Sutureless Purely Off-clamp Robotic Partial Nephrectomy: Evidence from a Randomized Controlled Noninferiority Trial

@article{brassetti2026sutureless,
  title = {{Sutureless Purely Off-clamp Robotic Partial Nephrectomy: Evidence from a Randomized Controlled Noninferiority Trial}},
  author = {Aldo Brassetti and Gabriele Tuderti and Umberto Anceschi and Alfredo Maria Bove and Eugenio Bologna and Lorenzo Capecchi and Giuseppe Chiacchio and Simone D’Annunzio and Mariaconsiglia C. Ferriero and Rocco Simone Flammia and Salvatore Guaglianone and Sabrina Iuculano and Claudia Denaro and Arianna Di Luzio and Costantino Leonardo and Leslie Claire Licari and Riccardo Mastroianni and Leonardo Misuraca and Flavia Proietti and Isabella Sperduti and Giuseppe Simone},
  journal = {European Urology},
  year = {2026},
  month = may,
  doi = {10.1016/j.eururo.2026.04.019},
  url = {https://doi.org/10.1016/j.eururo.2026.04.019},
  note = {CC BY},
}

TY  - JOUR
TI  - Sutureless Purely Off-clamp Robotic Partial Nephrectomy: Evidence from a Randomized Controlled Noninferiority Trial
AU  - Aldo Brassetti
AU  - Gabriele Tuderti
AU  - Umberto Anceschi
AU  - Alfredo Maria Bove
AU  - Eugenio Bologna
AU  - Lorenzo Capecchi
AU  - Giuseppe Chiacchio
AU  - Simone D’Annunzio
AU  - Mariaconsiglia C. Ferriero
AU  - Rocco Simone Flammia
AU  - Salvatore Guaglianone
AU  - Sabrina Iuculano
AU  - Claudia Denaro
AU  - Arianna Di Luzio
AU  - Costantino Leonardo
AU  - Leslie Claire Licari
AU  - Riccardo Mastroianni
AU  - Leonardo Misuraca
AU  - Flavia Proietti
AU  - Isabella Sperduti
AU  - Giuseppe Simone
PY  - 2026
DA  - 2026/05/15
JO  - European Urology
DO  - 10.1016/j.eururo.2026.04.019
UR  - https://doi.org/10.1016/j.eururo.2026.04.019
AB  - BACKGROUND AND OBJECTIVE: The sutureless (SL) purely off-clamp robotic partial nephrectomy (ocRPN) technique has been proposed to minimize postoperative functional damage. We assessed whether this approach is noninferior to renorrhaphy (RR) in terms of surgical quality. METHODS: Patients with cT1-2N0M0 renal tumors were randomly assigned to SL or RR-ocRPN within a single-center, single-surgeon randomized controlled trial (NCT06846112). A covariate-adaptive 1:1 randomization algorithm ensured balance between treatment arms for age, sex, baseline renal function, and tumor surgical complexity. The primary endpoint was Trifecta achievement at discharge. A prespecified noninferiority test (margin -10%) compared Trifecta rates using one-sided testing and confidence intervals. Secondary outcomes were descriptively analyzed and compared between study arms. Recurrence-free survival (RFS) was estimated using the Kaplan-Meier method. KEY FINDINGS AND LIMITATIONS: Among 248 patients, baseline characteristics were balanced. Trifecta was achieved in 93% and 95% of cases (absolute difference -2.4%; 90% confidence interval [CI] -7.4%-2.6%), meeting the criterion for noninferiority (one-sided p = 0.006). Blood transfusions (2.4% vs 0%) and acute kidney injury (1.6% in both groups) were rare. Nine urinary fistulae occurred overall, all managed with temporary stenting; rates were higher in the SL group but not statistically significant (p = 0.08). Renal function remained stable up to 12 mo, and 1-yr RFS was 99% in all cohorts. Limitations include single-center design, surgeon expertise, and short oncologic follow-up. CONCLUSIONS AND CLINICAL IMPLICATIONS: SL-ocRPN is safe and effective and represents a feasible alternative to RR-ocRPN in selected cT1-2N0M0 renal tumors.
SN  - 0302-2838
SN  - 1421-993X
SN  - 1873-7560
ER  -