Comparative Study Between Outcome of ICT Drainage and VATS in Management of Second Stage Empyema

NCT ID: NCT06680024

Last Updated: 2024-11-08

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-10

Study Completion Date

2025-07-31

Brief Summary

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The goal of this clinical trial is to compare between outcome of inter-costal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema.

It compares the outcome of both interventions in hospital stay, cost, wether need of decortication later on or not.

Detailed Description

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Conditions

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Second Stage Empyema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intercostal tube

Intercostal tube as a primary intervention for treatment of second stage empyema

Group Type ACTIVE_COMPARATOR

Intercostal tube

Intervention Type PROCEDURE

Intercostal tube drainage as a first management of second stage empyema

Video assisted thoracoscope

Video assisted thoracoscopic evacuation as a primary intervention for treatment of nd stage empyema

Group Type ACTIVE_COMPARATOR

Video assisted thoracoscope

Intervention Type PROCEDURE

Video assisted thoracoscopic surgery as a first management for second stage empyema

Interventions

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Intercostal tube

Intercostal tube drainage as a first management of second stage empyema

Intervention Type PROCEDURE

Video assisted thoracoscope

Video assisted thoracoscopic surgery as a first management for second stage empyema

Intervention Type PROCEDURE

Other Intervention Names

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Chest tube VATS

Eligibility Criteria

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Inclusion Criteria

* Patients both adults and children diagnosed as Empyema thoracis in early stages based on clinical examination, imaging modalities and pleural fluid analysis

Exclusion Criteria

* Empyema due to carcinoma, terminally ill patients, patients with severe respiratory distress at admission, patients not fit for surgery, patients with co morbid diseases like cardiac disorders and immunosuppression.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Sayed Khalaf

Resident at cardiothoracic surgery department, sohag university hospitals

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mostafa Sayed Khalaf

Role: CONTACT

01027582257 ext. +20

Related Links

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Other Identifiers

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Soh-Med-24-09-10MS

Identifier Type: -

Identifier Source: org_study_id

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