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

November 7, 2024 updated by: Mostafa Sayed Khalaf, Sohag University

Comparative Study Between Outcome of Inter-costal Tube Drainage and Video Assisted Thoracoscopic Surgery in Management of Second Stage Empyema

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intercostal tube
Intercostal tube as a primary intervention for treatment of second stage empyema
Procedure: Intercostal tube
Intercostal tube drainage as a first management of second stage empyema
Other Names:
  • Chest tube
Active Comparator: Video assisted thoracoscope
Video assisted thoracoscopic evacuation as a primary intervention for treatment of nd stage empyema
Procedure: Video assisted thoracoscope
Video assisted thoracoscopic surgery as a first management for second stage empyema
Other Names:
  • VATS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the length of hospital stay
Time Frame: From enrollment to 4 weeks
Comparison between both intercostal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema, we will compare the length of hospital stay of each group of patients
From enrollment to 4 weeks
cost of treatment of the patients' in each group
Time Frame: 4 weeks
Comparison between both intercostal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema, we will compare cost of treatment of the patients' in each group
4 weeks
number of participants with needs of decortication later on or not, assessed by the chest X-ray and CT chest.
Time Frame: 4 weeks
Comparison between both intercostal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema, we will compare with the chest X-ray and CT chest if there is residual empyema and whether the patients will need decortication later on or not
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 10, 2024

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Estimated)

November 8, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-09-10MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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