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Clinical Trials/NCT04933604
NCT04933604
Completed
Not Applicable

Comparison of Laparoscopic Partial Nephrectomy Versus Laparoscopic Radical Nephrectomy in Patients With High-Complexity Renal Tumors: A Propensity Score Matched Analysis

Samsun Liv Hospital1 site in 1 country78 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Cancer
Sponsor
Samsun Liv Hospital
Enrollment
78
Locations
1
Primary Endpoint
Postoperative complication
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
February 4, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Samsun Liv Hospital
Responsible Party
Principal Investigator
Principal Investigator

Mehmet Necmettin Mercimek

Principal Investigator

Samsun Liv Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Postoperative complication

Time Frame: up to 3 months postoperatively

abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up

functional outcomes

Time Frame: 1 year after the surgery

serum creatinine level (mg /dL) and estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)

surigcal margin status

Time Frame: postoperative follow-up, through study completion, an average of 1 year

presence or absence of tumors at the surgical margin

CKD stage upgrading

Time Frame: postoperative follow-up, through study completion, an average of 1 year

evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages

Oncological outomes

Time Frame: postoperative follow-up, through study completion, an average of 1 year

Presence or absence of local and/or distal tumor recurrence

Operation time

Time Frame: at the end of the surgery

time from onset to complete of surgery

Blood loss

Time Frame: at the end of the surgery

amount of bleeding during surgery (mL)

warm ischemia time

Time Frame: at the and of the surgery

The clamp time of the renal artery and vein which is required to complete tumor excision and renorrhaphy

Study Sites (1)

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