Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

Conditions
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Kidney Neoplasms

Intervention / Treatment
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* Procedure: Partial nephrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic Partial Nephrectomy<br>Patients with kidney neoplasms submitted to laparoscopic partial nephrectomy | Procedure: Partial nephrectomy<br> <br> |
| Active Comparator: Open Partial Nephrectomy<br>Patients with kidney neoplasms submitted to open partial nephrectomy | Procedure: Partial nephrectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Complications |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function |  | 2 years | 
| Oncological outcomes |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Neoplasms, Minimally invasive surgery, Renal cell carcinoma