Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

University of Sao Paulo

Status: Unknown

Conditions: Kidney Neoplasms

Treatments: Procedure: Partial nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01809119

UROUSP - 005

Details and patient eligibility

About

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.

Enrollment: 242 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

Laparoscopic Partial Nephrectomy

Experimental group

Description:

Patients with kidney neoplasms submitted to laparoscopic partial nephrectomy

Treatment:

Procedure: Partial nephrectomy

Open Partial Nephrectomy

Active Comparator group

Description:

Patients with kidney neoplasms submitted to open partial nephrectomy

Treatment:

Procedure: Partial nephrectomy