Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy

NCT06960135 | Completed DMC

• 1 other identifier: SVU-MED-URO016-2-22-5-400
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Trifecta Achievement; Pentafecta Achievement

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Predictors of Trifecta Achievement in Open ald Laparoscopic Partial Nephrectomy for Localised Renal Tumors

  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.

  2 years

Secondary Outcomes (1)

• Pentafecta Achivement

  2 yrs

Study Arms (2)

open partial nephrectomy

ACTIVE COMPARATOR

open partial nephrectomy

Procedure: open partial nephrectomy

laparoscopic partial nephrectomy

ACTIVE COMPARATOR

laparoscopic partial nephrectomy

Procedure: laparoscopic partial nephrectomy

Interventions

open partial nephrectomy PROCEDURE

open partial nephrectomy

open partial nephrectomy

laparoscopic partial nephrectomy PROCEDURE

laparoscopic partial nephrectomy

laparoscopic partial nephrectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

SVU hospital

Qena, Egypt, Qena Governorate, 83511, Egypt

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 7, 2025
• Study Start: June 1, 2022
• Primary Completion: May 30, 2024
• Study Completion: March 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

EG (1)