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Trial Title:
Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
NCT ID:
NCT01809119
Condition:
Kidney Neoplasms
Conditions: Official terms:
Kidney Neoplasms
Conditions: Keywords:
Kidney Neoplasms, Minimally invasive surgery, Renal cell carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Partial nephrectomy
Arm group label:
Laparoscopic Partial Nephrectomy
Arm group label:
Open Partial Nephrectomy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Cancer Institute of the State of São Paulo
Address:
City:
Sao Paulo
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Sanarelly P Adonias, Study Coordinator
Phone:
+55 11 3893-2528
Email:
enfpesq2.urousp@gmail.com
Investigator:
Last name:
Marcos F Dall'Oglio, M.D Associate Professor
Email:
Principal Investigator
Start date:
December 2012
Completion date:
January 2020
Lead sponsor:
Agency:
University of Sao Paulo
Agency class:
Other
Collaborator:
Agency:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Agency class:
Other
Source:
University of Sao Paulo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01809119
