Predictors of Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- South Valley University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Predictors of Trifecta Achievement in Open ald Laparoscopic Partial Nephrectomy for Localised Renal Tumors
Study Overview
Brief Summary
Background: Partial nephrectomy (PN) is a reference standard for the management of the cT1 renal mass, primarily due to better preservation of renal function. The aim of this work was to determine trifecta outcomes of open PN (OPN) and laparoscopic PN (LPN) and identify predictive factors for trifecta achievement to evaluate surgical performance, including negative surgical margins, absence of severe surgical complications, and ischemia time less than 25 minutes.
Objectives: this study pointing to determine trifecta outcomes of OPN and LPN and to identify predictive factors for trifecta achievement to evaluate surgical performance, including negative surgical margins, absence of severe surgical complications, and Ischemia time less than 25 Minutes.
Detailed Description
Methods: This prospective, randomized study was carried out on 35 patients with clinical T1 N0M0 renal tumors. Patients were divided into two groups: Group A (n=38): underwent OPN and group B (n=32): underwent LPN.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •• Patients who are fit for surgery.
- •Patients with renal tumor who are indicated for partial nephrectomy
- •Solitary kidney.
- •Bilateral renal tumor.
- •Abnormal contralateral kidney (nephropathy, nephrolithiasis, trauma).
- •Metabolic disease associated with renal failure (DM, hypertension).
- •Genetic syndrome with tumor multifocality (VHL syndrome). Elective
- •Clinical T1N0M0 Tumor.
- •Peripheral tumor.
Exclusion Criteria
- •• Patients who are unfit for surgery and who's unfit for laparoscopy.
- •Patients who are contraindicated for partial nephrectomy. As severe and irreversible coagulopathy. Patients who are indicated for radical nephrectomy (extensive tumor, metastatic tumor).
Arms & Interventions
open partial nephrectomy
open partial nephrectomy
Intervention: open partial nephrectomy (Procedure)
laparoscopic partial nephrectomy
laparoscopic partial nephrectomy
Intervention: laparoscopic partial nephrectomy (Procedure)
Outcomes
Primary Outcomes
Predictors of Trifecta Achievement in Open ald Laparoscopic Partial Nephrectomy for Localised Renal Tumors
Time Frame: 2 years
Trifecta achievement is defined as the combination of (1) negative surgical margins, (2) absence of perioperative complications classified as Clavien-Dindo grade III or higher, and (3) warm ischemia time ≤25 minutes. factors affecting trifecta achievement among variables including tumor complexity score, patient comorbidities, BMI, surgical approches, special habbites, age or gender.
Secondary Outcomes
- Pentafecta Achivement(2 yrs)
Investigators
Omar Ahmad Bakheet
Assistant Lecturer
South Valley University