Surgery Clinical Trial
Official title:
Comparison of Laparoscopic Partial Nephrectomy Versus Laparoscopic Radical Nephrectomy in Patients With High-Complexity Renal Tumors: A Propensity Score Matched Analysis
Verified date | June 2021 |
Source | Samsun Liv Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study aims to investigate the rationale for LPN in patients with high-complexity renal tumors in terms of oncologic and functional outcomes.
Status | Completed |
Enrollment | 78 |
Est. completion date | February 4, 2021 |
Est. primary completion date | May 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients with complete data - Patients with single renal tumor on the effected side - Patients who approved the written consent form Exclusion Criteria: - Patients who not approved the written consent form - Patients with incomplete data - Patients with low or mild complexity renal tumors |
Country | Name | City | State |
---|---|---|---|
Turkey | Ondokuz Mayis University, Department of Urology | Samsun |
Lead Sponsor | Collaborator |
---|---|
Samsun Liv Hospital | Ondokuz Mayis University |
Turkey,
Kim SP, Campbell SC, Gill I, Lane BR, Van Poppel H, Smaldone MC, Volpe A, Kutikov A. Collaborative Review of Risk Benefit Trade-offs Between Partial and Radical Nephrectomy in the Management of Anatomically Complex Renal Masses. Eur Urol. 2017 Jul;72(1):6 — View Citation
Mir MC, Derweesh I, Porpiglia F, Zargar H, Mottrie A, Autorino R. Partial Nephrectomy Versus Radical Nephrectomy for Clinical T1b and T2 Renal Tumors: A Systematic Review and Meta-analysis of Comparative Studies. Eur Urol. 2017 Apr;71(4):606-617. doi: 10. — View Citation
Yang F, Zhou Q, Xing N. Comparison of survival and renal function between partial and radical laparoscopic nephrectomy for T1b renal cell carcinoma. J Cancer Res Clin Oncol. 2020 Jan;146(1):261-272. doi: 10.1007/s00432-019-03058-z. Epub 2019 Nov 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operation time | time from onset to complete of surgery | at the end of the surgery | |
Primary | Blood loss | amount of bleeding during surgery (mL) | at the end of the surgery | |
Primary | warm ischemia time | The clamp time of the renal artery and vein which is required to complete tumor excision and renorrhaphy | at the and of the surgery | |
Primary | Postoperative complication | abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up | up to 3 months postoperatively | |
Primary | functional outcomes | serum creatinine level (mg /dL) and estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2) | 1 year after the surgery | |
Primary | surigcal margin status | presence or absence of tumors at the surgical margin | postoperative follow-up, through study completion, an average of 1 year | |
Primary | CKD stage upgrading | evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages | postoperative follow-up, through study completion, an average of 1 year | |
Primary | Oncological outomes | Presence or absence of local and/or distal tumor recurrence | postoperative follow-up, through study completion, an average of 1 year |
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