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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04933604
Other study ID # OMU KAEK 11.07.2019/538
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date February 4, 2021

Study information

Verified date June 2021
Source Samsun Liv Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims to investigate the rationale for LPN in patients with high-complexity renal tumors in terms of oncologic and functional outcomes.


Description:

From November 2009 to October 2018, 399 patients underwent LPN and 307 patients to laparoscopic radical nephrectomy (LRN). 41 patients with RENAL score ≥ 10 enrolled in LPN and 265 patients to the LRN group. Propensity score matching (matched by age, gender, clinical tumor stage, tumor size, baseline renal function, comorbidities such as diabetes mellitus (DM), hypertension (HT), coronary artery disease (CAD), and final tumor pathology of RCC) was used to reduce selection bias. Functional and oncological outcomes were compared between the two groups. After propensity score analysis, 39 patients in the LRN group were matched with 39 in the LPN group.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
laparoscopic partial nephrectomy
Nephron sparing minimally invasive surgery
Laparoscopic radical nephrectomy
Completely removal of kidney by using laparoscopic surgery

Locations

Country Name City State
Turkey Ondokuz Mayis University, Department of Urology Samsun

Sponsors (2)

Lead Sponsor Collaborator
Samsun Liv Hospital Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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

Outcome

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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