Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

Kidney Neoplasms Clinical Trial

Official title:

Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01809119
• Other study ID #: UROUSP - 005
• Status: Recruiting
• Phase: N/A
• Start date: December 2012
• Est. completion date: January 2020

Study information

• Verified date: May 2018
• Source: University of Sao Paulo
• Contact: Sanarelly P Adonias, Study Coordinator
• Phone: + 55 11 3893-2528
• Email: enfpesq2.urousp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Neoplasms

Intervention

Procedure:
• Partial nephrectomy

Locations

Country	Name	City	State
Brazil	Cancer Institute of the State of São Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Complications		6 months
Secondary	Renal Function		2 years
Secondary	Oncological outcomes		5 years