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Completed

NCT Number: NCT06969131

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

open partial nephrectomy

Procedure

Patients underwent open partial nephrectomy.

laparoscopic partial nephrectomy

Procedure

Patients underwent laparoscopic partial nephrectomy.

Primary outcomes

  1. Predictor of pentafecta achievement

    Time frame: 12 months postoperatively

    Predictor of pentafecta achievement, such as smoking index, was recorded.

Secondary outcomes

  1. Amount of blood loss

    Time frame: Intraoperatively

    Amount of blood loss was recorded.

  2. Surgery duration

    Time frame: Intraoperatively

    Surgery duration was recorded.

  3. Length of hospital stay

    Time frame: Till discharge from hospital (Up to one week).

    Length of hospital stay was recorded from admission till the discharge from hospital.

  4. Intraoperative complications

    Time frame: Intraoperatively

    Intraoperative complications were recorded.

  5. Degree of pain

    Time frame: 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").

  6. Analgesic requirements

    Time frame: 24 hours postoperatively

    Incidence of required analgesic was recorded.

  7. Incidence of complications following surgery

    Time frame: 12 months postoperatively

    Incidence of complications following surgery were recorded.

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 13, 2025
Registry last updated
May 13, 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.

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