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Effect of Non-Clamping and Sutureless Technique on Postoperative Renal Function in Robot-Assisted Partial Nephrectomy

RecruitingNAAges 18 Years - 75 YearsAllShao Pengfei
NCT07888608 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Partial nephrectomy is an operation that removes a kidney tumor while leaving the rest of the kidney in place. It is used to treat selected patients with small tumors confined to the kidney. Robot-assisted surgery allows the surgeon to control surgical instruments precisely during this procedure. During standard surgery, the surgeon temporarily clamps the artery supplying the kidney to reduce bleeding while removing the tumor. The surgeon then closes the wound with stitches to help prevent bleeding and urine leakage. However, temporarily stopping blood flow and stitching the surrounding kidney tissue may affect how well the kidney works after surgery. An alternative approach, called "off-clamp, sutureless" surgery, removes the tumor without clamping the kidney artery and uses materials that help stop bleeding instead of stitches to close the wound. This approach may reduce injury to he

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📋 Eligibility rules (as published)
Inclusion Criteria: * Imaging indicates a renal tumor measuring ≤5 cm. * The tumor is located ≥4 mm from the collecting system. * Total R.E.N.A.L. nephrometry score ≤9. * Age 18-75 years. * American Society of Anesthesiologists (ASA) physical status classification ≤III. * Preoperative estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m². Exclusion Criteria: * Missing preoperative imaging or laboratory test results. * Preoperative imaging indicating a completely endophytic tumor or tumor involvement of the collecting system. * Evidence of distant metastasis or lymph node metastasis on preoperative imaging. * Receipt of preoperative antitumor treatment, such as targeted therapy or immunotherapy. * Preoperative hydronephrosis, renal calculi, or other conditions affecting renal function; or use of medications or treatments that may affect renal function. * Solitary kidney, previous renal surgery, chronic kidney disease, multiple renal tumors, or bilateral renal tumors. * Severe systemic disease or other conditions that may interfere with the study. * Refusal to participate in the study or refusal to sign the informed consent form. * Poor compliance or inability to complete follow-up assessments required to obtain the study endpoints.
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What it tests

  • Off-Clamp, Sutureless Robot-Assisted Partial Nephrectomy
  • Conventional Robot-Assisted Partial Nephrectomy With Artery Clamping and Sutured Reconstruction
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Where

1 site
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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