Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

May 8, 2018 updated by: Marcos Francisco Dall'Oglio, University of Sao Paulo
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

242

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 01246-000
        • Recruiting
        • Cancer Institute of the State of São Paulo
        • Contact:
        • Principal Investigator:
          • Marcos F Dall'Oglio, M.D Associate Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic Partial Nephrectomy
Patients with kidney neoplasms submitted to laparoscopic partial nephrectomy
Procedure: Partial nephrectomy
Active Comparator: Open Partial Nephrectomy
Patients with kidney neoplasms submitted to open partial nephrectomy
Procedure: Partial nephrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surgical Complications
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Renal Function
Time Frame: 2 years
2 years
Oncological outcomes
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Study Director: Marcos F Dall'Oglio, M.D., Associate Professor, Cancer Institute of the State of São Paulo - University of Sao Paulo
  • Principal Investigator: Giuliano B Guglielmetti, Doctor, Cancer Institute of the State of São Paulo - University of Sao Paulo
  • Study Chair: Alexandre C Sant'Anna, Doctor, Cancer Institute of the State of São Paulo - University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

March 8, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 12, 2013

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UROUSP - 005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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