Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy

Not Applicable

Completed

• Conditions: Trifecta Achievement; Pentafecta Achievement

• Registration Number: NCT06960135
• Lead Sponsor: South Valley University

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 Timeline

• Study Start: 2022-06-01
• Primary Completion: 2024-05-30
• Study Completion: 2025-03-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-04-28
• Study First Posted: 2025-05-07
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

4. 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Predictors of Trifecta Achievement in Open ald Laparoscopic Partial Nephrectomy for Localised Renal Tumors	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 Outcome Measures

Name	Time	Method
Pentafecta Achivement	2 yrs	Pentafecta 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.

Trial Locations

Locations (1)

SVU hospital; 🇪🇬 Qena, Egypt, Qena, Egypt