Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Laparoscopic Partial Nephrectomy

Patients with kidney neoplasms submitted to laparoscopic partial nephrectomy

Group Type EXPERIMENTAL

Partial nephrectomy

Intervention Type PROCEDURE

Open Partial Nephrectomy

Patients with kidney neoplasms submitted to open partial nephrectomy

Group Type ACTIVE_COMPARATOR

Partial nephrectomy

Intervention Type PROCEDURE

Interventions

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Partial nephrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes