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Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01809119
Enrollment
242
Registered
2013-03-12
Start date
2012-12-31
Completion date
2020-01-31
Last updated
2018-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Neoplasms

Keywords

Kidney Neoplasms, Minimally invasive surgery, Renal cell carcinoma

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.

Interventions

PROCEDUREPartial nephrectomy

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Surgical Complications6 months

Secondary

MeasureTime frame
Renal Function2 years
Oncological outcomes5 years

Countries

Brazil

Contacts

Primary ContactSanarelly P Adonias, Study Coordinator
enfpesq2.urousp@gmail.com+ 55 11 3893-2528

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026