Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
Phase 2/Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Kidney Neoplasms
Both
Kidney Neoplasms
Trial Information
Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
Inclusion Criteria:
- Patients with renal tumor cT1N0M0; (<7 cm)
- Normal renal function (serum creatinine <1.2 and glomerular filtration rate>
60mL/min/1.73m2)
- Tumor only
Exclusion Criteria:
- Functional or anatomical solitary kidney
- Horseshoe kidney, ectopic or malformed
- Clinical contraindication to surgery
- Contraindication to laparoscopic surgery
- Association with other renal pathologies
- Evidence of lymph node or systemic disease in preoperative staging
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Surgical Complications
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Marcos F Dall'Oglio, M.D., Associate Professor
Investigator Role:
Study Director
Investigator Affiliation:
Cancer Institute of the State of São Paulo - University of Sao Paulo
Authority:
Brazil: Ethics Committee
Study ID:
UROUSP - 005
NCT ID:
NCT01809119
Start Date:
December 2012
Completion Date:
February 2015
Related Keywords:
- Kidney Neoplasms
- Kidney Neoplasms, Minimally invasive surgery, Renal cell carcinoma
- Neoplasms
- Kidney Neoplasms
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