Current Role of Pentafecta Outcomes in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors

The Current Role of Pentafecta Outcomes in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors

This study aimed to identify predictive factors associated with the achievement of pentafecta outcomes following partial nephrectomy.

Study Overview

• Status: Completed
• Conditions: Partial Nephrectomy; Laparoscopic; Renal Tumors; Pentafecta
• Intervention / Treatment: Procedure: Open Partial Nephrectomy; Procedure: Laparoscopic Partial Nephrectomy

Detailed Description

Partial nephrectomy (PN) is widely considered the preferred treatment for clinical T1 (cT1) renal masses, primarily because it preserves kidney function more effectively than radical nephrectomy.

The trifecta metric includes three components: warm ischemia time (WIT) of ≤ 25 minutes or cold ischemia time (CIT) of ≤ 60 minutes, negative surgical margins, and the absence of perioperative major complications. The pentafecta expands upon these criteria by adding two additional parameters: preservation of ≥ 90% of the estimated glomerular filtration rate (eGFR) and no progression in chronic kidney disease (CKD) stage within 12 months postoperatively.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qena
    • South Valley, Qena, Egypt, 83523
      • South Valley University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years.
• Both sexes.
• Patients who diagnosed with clinical T1 or T2a N0M0 renal tumors who were suitable candidates for partial nephrectomy

Exclusion Criteria:

• Severe and irreversible coagulopathy.
• Anatomically unfavorable tumor location.
• Extensive encasement of the renal pedicle.
• Diffuse invasion of the renal vein or central collecting system.
• Adjacent organ invasion consistent with stage cT4 disease.
• Regional lymphadenopathy (stage cTxN1), or anticipated retention of less than 20% of total nephron mass.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Partial Nephrectomy; Patients underwent open partial nephrectomy.	Procedure: Open Partial Nephrectomy; Patients underwent open partial nephrectomy.
Experimental: Laparoscopic Partial Nephrectomy; Patients underwent laparoscopic partial nephrectomy.	Procedure: Laparoscopic Partial Nephrectomy; Patients underwent laparoscopic partial nephrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictor of pentafecta achievement	Predictor of pentafecta achievement, such as smoking index, was recorded.	12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of blood loss	Amount of blood loss was recorded.	Intraoperatively
Surgery duration	Surgery duration was recorded.	Intraoperatively
Length of hospital stay	Length of hospital stay was recorded from admission till the discharge from hospital.	Till discharge from hospital (Up to one week).
Intraoperative complications	Intraoperative complications were recorded.	Intraoperatively
Degree of pain	Each patient will be instructed about postoperative pain assessment with the visual analog scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").	24 hours postoperatively
Analgesic requirements	Incidence of required analgesic was recorded.	24 hours postoperatively
Incidence of complications following surgery	Incidence of complications following surgery were recorded.	12 months postoperatively

Collaborators and Investigators

• Sponsor: South Valley University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: April 27, 2025
• First Submitted That Met QC Criteria: May 6, 2025
• First Posted (Actual): May 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Kidney Neoplasms
• Other Study ID Numbers: SVU/MED/URO016/2/22/5/400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No