Comparing robotic kidney surgery techniques for cancer treatment
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
This study is testing two different robotic surgery methods for kidney cancer to see which one helps patients recover better and faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06846112 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare two surgical techniques for robotic partial nephrectomy in patients with kidney cancer: one that uses renorrhaphy (suture closure) and one that does not. The study focuses on minimizing ischemia during the procedure by employing cautery methods instead of sutures to close the resection site. It evaluates the impact of these techniques on postoperative renal function, intervention time, and overall costs. The trial is based on preliminary data suggesting that the non-suturing approach may not compromise surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with organ-confined renal neoplasms who are suitable for robotic partial nephrectomy.
Not a fit: Patients with synchronous renal neoplasms or a history of renal surgery for any pathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced costs for patients undergoing kidney cancer surgery.
How similar studies have performed: Preliminary studies have shown promising results for similar surgical approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Aldo Brassetti, Doctor — IRCCS "Regina Elena" National Cancer Institute
- Study coordinator: Aldo Brassetti, Doctor
- Email: aldo.brassetti@ifo.it
- Phone: 06-52665005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.