Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

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Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

Condition: Kidney Neoplasms

Intervention:

  • Procedure: Partial nephrectomy

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01809119

Sponsor: University of Sao Paulo

Primary Outcome Measures:

  • Measure: Surgical Complications
  • Time Frame: 6 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Renal Function
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Oncological outcomes
  • Time Frame: 5 years
  • Safety Issue:

Estimated Enrollment: 242

Study Start Date: December 2012

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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

Contact:

  • Sanarelly P Adonias, Study Coordinator
  • + 55 11 3893-2528

Location:

  • Cancer Institute of the State of São Paulo
  • Sao Paulo 01246-000 Brazil

View trial on ClinicalTrials.gov

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