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

Not Applicable

Completed

• Conditions: Laparoscopic; Pentafecta; Partial Nephrectomy; Renal Tumors

• Registration Number: NCT06969131
• Lead Sponsor: South Valley University

Brief Summary

This study aimed to identify predictive factors associated with the achievement of pentafecta outcomes following 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 Timeline

• Study Start: 2022-05-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Study First Submitted: 2025-04-27
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Predictor of pentafecta achievement	12 months postoperatively	Predictor of pentafecta achievement, such as smoking index, was recorded.

Secondary Outcome Measures

Name	Time	Method
Amount of blood loss	Intraoperatively	Amount of blood loss was recorded.
Surgery duration	Intraoperatively	Surgery duration was recorded.
Length of hospital stay	Till discharge from hospital (Up to one week).	Length of hospital stay was recorded from admission till the discharge from hospital.
Intraoperative complications	Intraoperatively	Intraoperative complications were recorded.
Analgesic requirements	24 hours postoperatively	Incidence of required analgesic was recorded.
Incidence of complications following surgery	12 months postoperatively	Incidence of complications following surgery were recorded.
Degree of pain	24 hours postoperatively	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").

Trial Locations

Locations (1)

South Valley university; 🇪🇬 South Valley, Qena, Egypt