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Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

Primary Purpose

Kidney Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Partial nephrectomy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Kidney Neoplasms focused on measuring Kidney Neoplasms, Minimally invasive surgery, Renal cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cancer Institute of the State of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic Partial Nephrectomy

Open Partial Nephrectomy

Arm Description

Patients with kidney neoplasms submitted to laparoscopic partial nephrectomy

Patients with kidney neoplasms submitted to open partial nephrectomy

Outcomes

Primary Outcome Measures

Surgical Complications

Secondary Outcome Measures

Renal Function
Oncological outcomes

Full Information

First Posted
March 8, 2013
Last Updated
May 8, 2018
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01809119
Brief Title
Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
Official Title
Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Neoplasms
Keywords
Kidney Neoplasms, Minimally invasive surgery, Renal cell carcinoma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic Partial Nephrectomy
Arm Type
Experimental
Arm Description
Patients with kidney neoplasms submitted to laparoscopic partial nephrectomy
Arm Title
Open Partial Nephrectomy
Arm Type
Active Comparator
Arm Description
Patients with kidney neoplasms submitted to open partial nephrectomy
Intervention Type
Procedure
Intervention Name(s)
Partial nephrectomy
Primary Outcome Measure Information:
Title
Surgical Complications
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Renal Function
Time Frame
2 years
Title
Oncological outcomes
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanarelly P Adonias, Study Coordinator
Phone
+ 55 11 3893-2528
Email
enfpesq2.urousp@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcos F Dall'Oglio, M.D., Associate Professor
Organizational Affiliation
Cancer Institute of the State of São Paulo - University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giuliano B Guglielmetti, Doctor
Organizational Affiliation
Cancer Institute of the State of São Paulo - University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexandre C Sant'Anna, Doctor
Organizational Affiliation
Cancer Institute of the State of São Paulo - University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Institute of the State of São Paulo
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanarelly P Adonias, Study Coordinator
Phone
+55 11 3893-2528
Email
enfpesq2.urousp@gmail.com
First Name & Middle Initial & Last Name & Degree
Marcos F Dall'Oglio, M.D Associate Professor

12. IPD Sharing Statement

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Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

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