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Clinical Trials/NCT01809119
NCT01809119
Unknown
Not Applicable

Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

University of Sao Paulo1 site in 1 country242 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Neoplasms
Sponsor
University of Sao Paulo
Enrollment
242
Locations
1
Primary Endpoint
Surgical Complications
Last Updated
7 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
January 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marcos Francisco Dall'Oglio

M.D. Associate Professor

University of Sao Paulo

Eligibility 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

Outcomes

Primary Outcomes

Surgical Complications

Time Frame: 6 months

Secondary Outcomes

  • Oncological outcomes(5 years)
  • Renal Function(2 years)

Study Sites (1)

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