Not Yet RecruitingNot Applicable

Video-assisted Thoracoscopic Surgery (VATS) Has Revolutionised Management of Complicated PPE, Our Study to Determine VATS Decortication Technique is Needed, Compared to VATS Debridement in PPE, Also RAPID Score and Pleural US Parameters Can Predict Which VATS Procedure is Needed.

Egypt95 participantsStarted 2025-10-25

Plain-language summary

Video-assisted thoracoscopic surgery (VATS) has revolutionised management of complicated parapneumonic effusion ( PPE). So our study is prospective cohort study will be conducted at Departments of Chest Diseases and Cardiothoracic Surgery, Assiut University Hospitals * Aims: to determine the frequency of which VATS technique is needed (decortication versus debridement ) and to verify whether baseline RAPID score and pleural US parameters can predict which VATS procedure (decortication vs. debridement) in patients with complicated PPE will need, upon intra-operative exploration to compare the time to ICT removal after lung expansion and length of hospital stay in patients with PPE undergoing VATS via either debridement or decortication approach . * Subjects: All patients with PPE presenting with suggestive symptoms,signs or radiological studies which display compatible patterns of PPE: 1. Inclusion criteria: 1. Age \> 18 years 2. Patients diagnosed with PPE who are confirmed by (aspiration of frank pus from pleural cavity, positive culture for bacterial infection, pleural fluid with a pH ⩽7.2 (measured by blood gas analyser), low glucose level (⩽3 mmol/L or ⩽55 mg•dL-1), lactate dehydrogenase (LDH) \>200 IU/L) in a patient with clinical evidence of infection . 3. Failed resolution of parapneumonic effusion. 2. Exclusion criteria: 1. Patients unfit for/ or declining surgical intervention. 2. Iatrogenic or traumatic pyothorax. 3. Haemothorax or chylothorax regardless the etiology. 4. Exudative pleural effusion due to medical conditions other than pneumonia . * Sample size was calculated using Epi-info software version 7.2.5.0. The total sample size needed to detect such an estimate with 95% confidence level and 10% margin of error will be 95 patients * Research outcome measures: 1. Primary (main): * Number of the patients who will receive either VATS technique (and the respective percentage in relation to the total patients) * Preoperative Adjusted RAPID score and US findings (fluid volume, echogenicity, pleural thickening, consolidation and other incidental findings). * Assessment the radiological signs of lung expansion CXR/US scores: * Failure: Chest X-ray scoring 0 and chest US scoring 0. * Partially successful: Chest X-ray scoring 1 or 2 and chest US scoring 1. * Successful: Chest X-ray scoring 3 or 4, and chest US scoring 2 or 3. B. Secondary (subsidiary): * Time to ICT removal (days). ICT tube will be removed based on the MDT joint decision according to the patients' individual course. Tube removal is contemplated upon clinical resolution, complete fluid drainage, full lung expansion and absence of pleural air in CXR, in the absence of air leak, chest ultrasound to assess if there is residual pleural effusion. * Length of Hospital Stay (days) * Status at discharge (ICT removed or not) * Patients reported outcomes: * Postoperative pain (VAS) at discharge time * Resumption of usual activities (self-care routine with assistance - unassisted self-care- other activities indoors- independent indoors and outdoors activities) by attending the patient to the hospital within 30 days post discharge. * Mortality rate within 30 days postoperative.

Who can participate

Age range

18 Years

Sex

ALL

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Inclusion criteria

. Age \> 18 years
. Patients diagnosed with PPE who are confirmed by (aspiration of frank pus from pleural cavity, positive culture for bacterial infection, pleural fluid with a pH ⩽7.2 (measured by blood gas analyser), low glucose level (⩽3 mmol/L or ⩽55 mg•dL-1), lactate dehydrogenase (LDH) \>200 IU/L) in a patient with clinical evidence of infection \[6\].
. Failed resolution of parapneumonic effusion:

Exclusion criteria

. Patients unfit for/ or declining surgical intervention.
. Iatrogenic or traumatic pyothorax.
. Haemothorax or chylothorax regardless the aetiology.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment the radiological signs of lung expansion

Timeframe: perioperative

Preoperative Adjusted RAPID score and US findings

Timeframe: the baseline

Trial details

NCT IDNCT07188714

SponsorAssiut University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-10

Contact for this trial

Olfat Mostafa El Shinawy, MD

020 01211194877 dr_olfat_mostafa@aun.edu.eg

View on ClinicalTrials.gov More Parapneumonic Effussion trials