Clinical Trials Directory

Trials / Completed

CompletedNCT04213157

Laparoscopic Partial Nephrectomy for cT1 Tumors

Evaluation Trifecta and Pentafecta Outcomes of Patients Underwent Laparoscopic Partial Nephrectomy for cT1 Renal Tumor

Status
Completed
Phase
Study type
Observational
Enrollment
292 (actual)
Sponsor
Samsun Liv Hospital · Academic / Other
Sex
All
Age
18 Years – 82 Years
Healthy volunteers
Not accepted

Summary

The aim of the study is to evaluate trifecta and pentafecta outcomes for laparoscopic partial nephrectomy (LNP) in patients with clinical T1N0M0 renal tumor.

Detailed description

From November 2009 to August 2018 a total of 292 patients who underwent LPN by global ischemia were included in the study. The patients were allocated into two groups according to the tumor size; T1a (≤ 40 mm, n=215), T1b (41-70 mm, n=77). Demographics features, clinical tumor characteristics, intraoperative and postoperative outcomes were analyzed. A negative surgical margin, warm ischemia time (WIT) \< 20 min and no postoperative complications (Clavien-Dindo ≥ grade 3) were accepted to achieve the trifecta outcomes. Pentafecta has defined as trifecta criteria plus \>90% preservation of estimated glomerular filtration rate (eGFR) and no stage upgrade of chronic kidney disease 12 months after LPN. Univariable and multivariable analysis were used to identify factors predicting trifecta and pentafecta achievement.

Conditions

Timeline

Start date
2019-03-15
Primary completion
2019-08-30
Completion
2019-11-10
First posted
2019-12-30
Last updated
2020-01-02

Locations

2 sites across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04213157. Inclusion in this directory is not an endorsement.