Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy

NCT ID: NCT06960135

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Trifecta Achievement Pentafecta Achievement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open partial nephrectomy

open partial nephrectomy

Group Type ACTIVE_COMPARATOR

open partial nephrectomy

Intervention Type PROCEDURE

open partial nephrectomy

laparoscopic partial nephrectomy

laparoscopic partial nephrectomy

Group Type ACTIVE_COMPARATOR

laparoscopic partial nephrectomy

Intervention Type PROCEDURE

laparoscopic partial nephrectomy

Interventions

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open partial nephrectomy

open partial nephrectomy

Intervention Type PROCEDURE

laparoscopic partial nephrectomy

laparoscopic partial nephrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

1\. 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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Omar Ahmad Bakheet

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SVU hospital

Qena, Egypt, Qena Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id

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