Skip to main content
OpenTrials
Completed

NCT Number: NCT06960135

Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Trifecta Achievement Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pentafecta Achievement Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SVU hospital

Qena, Egypt, Qena Governorate, 83511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Patients who are fit for surgery.
  • Patients with renal tumor who are indicated for partial nephrectomy

Absolute:

  • Solitary kidney.
  • Bilateral renal tumor.
  • CDK.

Relative:

  • 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. 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).

Treatment and study plan

open partial nephrectomy

Procedure

open partial nephrectomy

laparoscopic partial nephrectomy

Procedure

laparoscopic partial nephrectomy

Primary outcomes

  1. 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

  1. Pentafecta Achivement

    Time frame: 2 yrs

    Pentafecta achievement is defined as the combination of:

    • negative surgical margins,
    • absence of major perioperative complications (Clavien-Dindo grade ≥III),
    • warm ischemia time ≤25 minutes,
    • ≥90% preservation of preoperative estimated glomerular filtration rate (eGFR), and
    • 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.

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Acronym: Trifecta

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.