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.

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.

Conditions

• Parapneumonic Effussion

Interventions

PROCEDURE

VATs decortication

A long thoracoscopic instruments are to be used for dissection, evacuation of pus and removal of the visceral peel at the surface of the lung. Instruments will be introduced below the lens in cases of uniportal procedure. Two ports VATS will be used early in this series by adding another 3-4 cm incision in the 3rd or 4th intercostal space anterior axillary line, scope will be introduced through the lower port and instruments will be introduced through the other. Irrigation with warm saline is to be done; breaking up the fine adhesions, the surgeon will take off the thick visceral peel over the lung surface, opening the fissures using combination of blunt and sharp dissection leaving the parietal pleura.

PROCEDURE

VATs debridement

Removal of pus, debris, granulation tissue is to remove as much as possible of the empyema biofilm while freeing the lung from any loculations. Following debridement and flushing the pleural cavity by warm saline, the attending anaesthiologist is to modify the ventilatory settings to attain the maximally allowed degree of lung expansion (TV criteria/peak/plateau/PV curve). Then, instillation of saline to obliterate the pleural cavity until saline leaks back from the operating port. If leakage starts after instillation of ≤200 cc. (obliteration of the whole pleural cavity including the cost phrenic angle will be assumed, lung is to be considered sufficiently expanded, and VATS will be withheld at debridement step. On the other hand, if leakage starts after instillation of ≥ 200 cc, lung entrapment and failure of expansion will be assumed, and surgery will proceed to VATS decortication to achieve reasonable lung expansion

Sponsors & Collaborators

• Assiut University

  lead OTHER

Principal Investigators

• Sara Mohamed Hashem, MD · Assiut Medical School

• Hend Mohamed Sayed, MD · Assiut Medical School

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-25

Primary Completion

2027-09-10

Completion

2028-02-10

Countries

• Egypt

Study Locations