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Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

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ClinicalTrials.gov Identifier: NCT01809119
Recruitment Status : Recruiting
First Posted : March 12, 2013
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Marcos Francisco Dall'Oglio, 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.

Condition or disease Intervention/treatment Phase
Kidney Neoplasms Procedure: Partial nephrectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
Study Start Date : December 2012
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

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



Primary Outcome Measures :
  1. Surgical Complications [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Renal Function [ Time Frame: 2 years ]
  2. Oncological outcomes [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809119


Contacts
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Contact: Sanarelly P Adonias, Study Coordinator + 55 11 3893-2528 enfpesq2.urousp@gmail.com

Locations
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Brazil
Cancer Institute of the State of São Paulo Recruiting
Sao Paulo, Brazil, 01246-000
Contact: Sanarelly P Adonias, Study Coordinator    +55 11 3893-2528    enfpesq2.urousp@gmail.com   
Principal Investigator: Marcos F Dall'Oglio, M.D Associate Professor         
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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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

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Responsible Party: Marcos Francisco Dall'Oglio, M.D. Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01809119     History of Changes
Other Study ID Numbers: UROUSP - 005
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Keywords provided by Marcos Francisco Dall'Oglio, University of Sao Paulo:
Kidney Neoplasms, Minimally invasive surgery, Renal cell carcinoma

Additional relevant MeSH terms:
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Kidney Neoplasms
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases