NCT07888608 Effect of Non-Clamping and Sutureless Technique on Postoperative Renal Function in Robot-Assisted Partial Nephrectomy

Eligibility & Interventions

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This trial targets 304 participants in total. It began in 2026-10-01 with a primary completion date of 2028-10-01.

Brief Summary

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 healthy kidney tissue. Early studies, including research at the investigators' hospital, suggest that it may help preserve kidney function. However, stronger evidence is needed to determine how its benefits and risks compare with standard surgery. This study will randomly assign participants to receive either off-clamp, sutureless robot-assisted partial nephrectomy or standard robot-assisted partial nephrectomy with artery clamping and stitches. The study will compare kidney function and surgical safety between the two groups. It will also examine whether the results differ according to how complex the kidney tumor is. The findings may help identify which patients are most likely to benefit from the off-clamp, sutureless approach and guide the development of a standardized surgical procedure.

Eligibility Criteria

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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