LPN in Patients With High-complex Renal Tumors

Completed

• Conditions: Renal Cancer; Renal Cell Carcinoma; Surgery; Oncology; Kidney Injury; Urologic Cancer; Kidney Ischemia; Renal Neoplasm; Urologic Neoplasms; Kidney Neoplasms
• Interventions: Procedure: laparoscopic partial nephrectomy; Procedure: Laparoscopic radical nephrectomy

• Registration Number: NCT04933604
• Lead Sponsor: Samsun Liv Hospital

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.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-05-30
• Study Completion: 2021-02-04
• Study First Submitted: 2021-05-31
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-13
• Last Update Submitted: 2021-06-13
• Study First Posted: 2021-06-22
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LPN group	laparoscopic partial nephrectomy	39 patients with high complexity renal tumors who underwent laparoscopic partial nephrectomy
LRN group	Laparoscopic radical nephrectomy	39 patients with high complexity renal tumors who underwent laparoscopic radical nephrectomy

Primary Outcome Measures

Name	Time	Method
Postoperative complication	up to 3 months postoperatively	abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up
functional outcomes	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	postoperative follow-up, through study completion, an average of 1 year	presence or absence of tumors at the surgical margin
CKD stage upgrading	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	postoperative follow-up, through study completion, an average of 1 year	Presence or absence of local and/or distal tumor recurrence
Operation time	at the end of the surgery	time from onset to complete of surgery
Blood loss	at the end of the surgery	amount of bleeding during surgery (mL)
warm ischemia time	at the and of the surgery	The clamp time of the renal artery and vein which is required to complete tumor excision and renorrhaphy

Trial Locations

Locations (1)

Ondokuz Mayıs University, Department of Urology; 🇹🇷 Samsun, Turkey