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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

Tracking Information
First Submitted Date  ICMJE March 8, 2013
First Posted Date  ICMJE March 12, 2013
Last Update Posted Date May 14, 2018
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
Surgical Complications [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01809119 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
  • Renal Function [ Time Frame: 2 years ]
  • Oncological outcomes [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
Official Title  ICMJE Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Kidney Neoplasms
Intervention  ICMJE Procedure: Partial nephrectomy
Study Arms  ICMJE
  • Experimental: Laparoscopic Partial Nephrectomy
    Patients with kidney neoplasms submitted to laparoscopic partial nephrectomy
    Intervention: Procedure: Partial nephrectomy
  • Active Comparator: Open Partial Nephrectomy
    Patients with kidney neoplasms submitted to open partial nephrectomy
    Intervention: Procedure: Partial nephrectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 11, 2013)
242
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sanarelly P Adonias, Study Coordinator + 55 11 3893-2528 enfpesq2.urousp@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01809119
Other Study ID Numbers  ICMJE UROUSP - 005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marcos Francisco Dall'Oglio, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
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
PRS Account University of Sao Paulo
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP