- Design
- Single-centre, single-surgeon randomised non-inferiority trial
- Population
- 248 patients with cT1–2 N0 M0 renal tumours
- Primary outcome
- Trifecta achievement at discharge
- Effect
- 93% vs 95%, difference −2.4% (90% CI −7.4% to 2.6%), non-inferior
A single-surgeon trial in Italy randomised 248 patients with cT1–2 N0 M0 kidney tumours to off-clamp robotic partial nephrectomy either with or without renorrhaphy, balancing age, sex, renal function and tumour complexity.
Trifecta, a composite measure of surgical quality, was achieved in 93% without suturing and 95% with it, within the pre-set non-inferiority margin of 10 percentage points. Transfusion and acute kidney injury were rare, renal function was stable at 12 months, and one-year recurrence-free survival was 99%. Nine urinary fistulae occurred, more often in the sutureless group, although the difference was not significant; all settled with temporary stenting.
One expert surgeon with extensive off-clamp experience performed every case, so the result may not transfer to others, and oncological follow-up is short. It supports sutureless closure as an option in expert hands for selected tumours, not as a general technique. It was published in May 2026.
- Sutureless off-clamp partial nephrectomy is a reasonable option in expert hands for selected tumours.
- Warn patients about the possibility of urinary fistula, which was more frequent without renorrhaphy.
- Keep renorrhaphy where collecting system entry is likely or experience is limited.
- Follow oncological outcomes beyond one year before drawing firm conclusions.
Why it matters
Avoiding both clamping and suturing aims to preserve more kidney function.
Don't overread it
One surgeon at one centre, with one year of follow-up, limits how far this generalises.
The statistics, in plain English
Non-inferiority means the new approach was shown not to be meaningfully worse, here by no more than 10 percentage points. The 90% interval (−7.4% to 2.6%) sits inside that margin. It does not show the sutureless approach is better.
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