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Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
Conditions
Kidney Neoplasms
Conditions: official terms
Kidney Neoplasms
Conditions: Keywords
Kidney Neoplasms, Minimally invasive surgery, Renal cell carcinoma
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Partial nephrectomy
Type: Procedure
Overall Status
Recruiting
Summary
Partial nephrectomy is considered the standard treatment for renal tumors smaller than 7 cm. With the evolution of image diagnostic tools and dissemination of its use, smaller tumors are being commonly diagnosed and treated. The partial open nephrectomy is still considered the gold standard technique for nephron sparing surgery, especially when the surgeon is not experienced with the minimally invasive surgery. In the last 15 years, uncountable minimally invasive techniques were developed, including the laparoscopic partial nephrectomy. The objective of this study is compare the partial laparoscopic nephrectomy to open partial nephrectomy in terms of perioperative, oncologic and functional outcomes. A balanced randomized prospective trial will be conducted. One group of patients will be submitted to to open partial nephrectomy while the other group of patients will be submitted to laparoscopic partial nephrectomy. A randomized prospective trial comparing the two techniques is necessary to determine the differences in outcomes between them and if the laparoscopic partial nephrectomy can be performed without harms to the patients.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Location
Cancer Institute of the State of São Paulo
Sao Paulo, Brazil
Status: Recruiting
Contact: Sanarelly P Adonias, Study Coordinator - +55 11 3893-2528 - enfpesq2.urousp@gmail.com
Start Date
December 2012
Completion Date
February 2015
Sponsors
University of Sao Paulo
Source
University of Sao Paulo
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page