Comparative Study Between Outcome of ICT Drainage and VATS in Management of Second Stage Empyema
ICT and VATS
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2024
CompletedFirst Posted
Study publicly available on registry
November 8, 2024
CompletedStudy Start
First participant enrolled
November 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedNovember 8, 2024
September 1, 2024
9 months
November 5, 2024
November 7, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
the length of hospital stay
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
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.
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
Study Arms (2)
Intercostal tube
ACTIVE COMPARATORIntercostal tube as a primary intervention for treatment of second stage empyema
Video assisted thoracoscope
ACTIVE COMPARATORVideo assisted thoracoscopic evacuation as a primary intervention for treatment of nd stage empyema
Interventions
Intercostal tube drainage as a first management of second stage empyema
Video assisted thoracoscopic surgery as a first management for second stage empyema
Eligibility Criteria
You may qualify if:
- Patients both adults and children diagnosed as Empyema thoracis in early stages based on clinical examination, imaging modalities and pleural fluid analysis
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident at cardiothoracic surgery department, sohag university hospitals
Study Record Dates
First Submitted
November 5, 2024
First Posted
November 8, 2024
Study Start
November 10, 2024
Primary Completion
July 30, 2025
Study Completion
July 31, 2025
Last Updated
November 8, 2024
Record last verified: 2024-09