LPN in Patients With High-complex Renal Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| LPN group 39 patients with high complexity renal tumors who underwent laparoscopic partial nephrectomy |
Procedure: laparoscopic partial nephrectomy
Nephron sparing minimally invasive surgery
|
| LRN group 39 patients with high complexity renal tumors who underwent laparoscopic radical nephrectomy |
Procedure: Laparoscopic radical nephrectomy
Completely removal of kidney by using laparoscopic surgery
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ondokuz Mayıs University, Department of Urology | Samsun | Turkey | 55020 |
Sponsors and Collaborators
- Samsun Liv Hospital
- Ondokuz Mayıs University
Investigators
- Study Director: Ender Ozden, Prof., Ondokuz Mayıs Üniversitesi, Tıp Fakültesi, Üroloji Anabilim dalı
- Study Chair: Saban Sarıkaya, Prof., Ondokuz Mayıs University, Faculty of Medicine, Department of Urology
- Principal Investigator: Mehmet Mercimek, MD, FEBU, Liv Hospital Samsun, Department of Urology
- Principal Investigator: Yakup Bostancı, Prof., Ondokuz Mayıs University, Faculty of Medicine, Department of Urology
- Principal Investigator: Murat Gulsen, MD, Samsun Gazi State Hospital, Departmen of Urology, Samsun, Turkey
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OMU KAEK 11.07.2019/538