Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

Not Applicable

• Conditions: Kidney Neoplasms
• Interventions: Procedure: Partial nephrectomy

• Registration Number: NCT01809119
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-05-14
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 242

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic Partial Nephrectomy	Partial nephrectomy	Patients with kidney neoplasms submitted to laparoscopic partial nephrectomy
Open Partial Nephrectomy	Partial nephrectomy	Patients with kidney neoplasms submitted to open partial nephrectomy

Primary Outcome Measures

Name	Time	Method
Surgical Complications	6 months

Secondary Outcome Measures

Name	Time	Method
Oncological outcomes	5 years
Renal Function	2 years

Trial Locations

Locations (1)

Cancer Institute of the State of São Paulo; 🇧🇷 Sao Paulo, Brazil