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Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy

Predictors of Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06960135
Acronym
Trifecta
Enrollment
70
Registered
2025-05-07
Start date
2022-06-01
Completion date
2025-03-01
Last updated
2025-05-07

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

Conditions

Pentafecta Achievement, Trifecta Achievement

Keywords

Laparoscopic, Partial Nephrectomy, Trifecta, Pentafecta Achievement, Renal Tumors

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.

Interventions

open partial nephrectomy

laparoscopic partial nephrectomy

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* • Patients who are fit for surgery. * Patients with renal tumor who are indicated for partial nephrectomy Absolute: 1. Solitary kidney. 2. Bilateral renal tumor. 3. CDK. Relative: 1. Abnormal contralateral kidney (nephropathy, nephrolithiasis, trauma). 2. Metabolic disease associated with renal failure (DM, hypertension). 3. Genetic syndrome with tumor multifocality (VHL syndrome). Elective 1\. Clinical T1N0M0 Tumor. 2. 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).

Design outcomes

Primary

MeasureTime frameDescription
Predictors of Trifecta Achievement in Open ald Laparoscopic Partial Nephrectomy for Localised Renal Tumors2 yearsTrifecta 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

MeasureTime frameDescription
Pentafecta Achivement2 yrsPentafecta achievement is defined as the combination of: 1. negative surgical margins, 2. absence of major perioperative complications (Clavien-Dindo grade ≥III), 3. warm ischemia time ≤25 minutes, 4. ≥90% preservation of preoperative estimated glomerular filtration rate (eGFR), and 5. no progression to a higher CKD stage at 12 months postoperative follow-up. Data will be collected from surgical, pathological, and clinical records. Predictors of Pentafecta achievement will be analyzed using multivariable logistic regression.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026