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Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy

S

South Valley University

Status

Completed

Conditions

Trifecta Achievement
Pentafecta Achievement

Treatments

Procedure: laparoscopic partial nephrectomy
Procedure: open partial nephrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06960135
SVU-MED-URO016-2-22-5-400

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

open partial nephrectomy
Active Comparator group
Description:
open partial nephrectomy
Treatment:
Procedure: open partial nephrectomy
laparoscopic partial nephrectomy
Active Comparator group
Description:
laparoscopic partial nephrectomy
Treatment:
Procedure: laparoscopic partial nephrectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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