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Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

NCT01809119 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2018-05-14

No results posted yet for this study

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.

Conditions

  • Kidney Neoplasms

Interventions

PROCEDURE

Partial nephrectomy

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Marcos F Dall'Oglio, M.D., Associate Professor · Cancer Institute of the State of São Paulo - University of Sao Paulo

  • Giuliano B Guglielmetti, Doctor · Cancer Institute of the State of São Paulo - University of Sao Paulo

  • Alexandre C Sant'Anna, Doctor · Cancer Institute of the State of São Paulo - University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2019-12-31
Completion
2020-01-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01809119 on ClinicalTrials.gov