Laparoscopic Partial Nephrectomy for cT1 Tumors

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate trifecta and pentafecta outcomes for laparoscopic partial nephrectomy (LNP) in patients with clinical T1N0M0 renal tumor.

Detailed Description
-----------------
From November 2009 to August 2018 a total of 292 patients who underwent LPN by global ischemia were included in the study. The patients were allocated into two groups according to the tumor size; T1a (≤ 40 mm, n=215), T1b (41-70 mm, n=77). Demographics features, clinical tumor characteristics, intraoperative and postoperative outcomes were analyzed. A negative surgical margin, warm ischemia time (WIT) < 20 min and no postoperative complications (Clavien-Dindo ≥ grade 3) were accepted to achieve the trifecta outcomes. Pentafecta has defined as trifecta criteria plus >90% preservation of estimated glomerular filtration rate (eGFR) and no stage upgrade of chronic kidney disease 12 months after LPN. Univariable and multivariable analysis were used to identify factors predicting trifecta and pentafecta achievement.

Official Title
-----------------
Evaluation Trifecta and Pentafecta Outcomes of Patients Underwent Laparoscopic Partial Nephrectomy for cT1 Renal Tumor

Conditions
-----------------
Renal Cancer, Renal Neoplasm, Renal Cell Carcinoma, Surgery, Surgery--Complications, Renal Functional Abnormality, Oncology, Oncology Problem, Kidney Ischemia, Kidney Injury, Urologic Neoplasms, Urologic Cancer, Kidney Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Functioning contraleteral kidney Patients with complete data Patients with single renal tumor on the effected side Patients who approved the written consent form Exclusion Criteria: The patients with bilateral renal tumors (n=8, 16 LPNs) solitary kidney (n=8) horseshoe kidney (n=4) pelvic ectopic kidney (n=2) graft kidney (n=2) those with multiple renal tumors in a single kidney (n=3) or with > 7 cm renal tumor (n=6) Patients who were operated on for colon cancer (n=4), prostate cancer (n=2), endometrial cancer (n=1) or adrenal mass (n=2) within the first year after LPN

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 82 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | time from onset to complete of surgery | at the end of the surgery | 
| Blood loss | amount of bleeding during surgery (mL) | at the end of the surgery | 
| 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 | 
| intraoperative complication | abnormal problmes that may be seen during surgery | at the end of the surgery | 
| Postoperative complication | abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up | up to 3 months | 
| functional outcomes | serum creatinine level and estimated glomerular filtration rate | up to 1 year postoperatively | 
| surigcal margin status | presence or absence of tumors at the surgical margin | up to 1 month postoperatively | 
| Relative decrease in renal function | Comparison of preoperative and postoperative renal functions according to numerical and percentile values | up to 1 year postoperatively | 
| CKD stage upgrading | evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages | up to 1 year postoperatively | 
| Oncological outomes | Presence or absence of local and/or distal tumor recurrence | up to the last clinical control (months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic partial nephrectomy, Trifecta, Pentafecta, Outcomes