Pediatric Video Assisted Thoracoscopic Surgery (VATS) in Management of Empyema (VATS)

Video Assisted Thoracoscopic Surgery (VATS) Versus Thoracotomy in Management of Empyema in Pediatric Patients

Thoracic surgeons have developed a thoracoscopic procedure which is less intrusive method allows complete evacuation and washing of the debris from the pleural cavity. This approach may also have the benefit of less invasive maneuver, a shorter hospital stay and a decreased rate of postoperative complications.

The aim of this study is to evaluate the advantages and disadvantages of the video-assisted thoracoscopic surgery (VATS) approach in comparison with thoracotomy in management of empyema in pediatric patients.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Empyema
• Intervention / Treatment: Procedure: video assisted thoracoscopy (VATS); Procedure: open thoracotomy

Detailed Description

comparison between VATS decortication and open thoracotomy in cases of pediatric empyema

• Study Type: Interventional
• Enrollment (Estimated): 73
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ali zein eladein, Ass.Lect.; Phone Number: +201014566896; Email: ali_zein@aun.edu.eg
• Study Contact Backup: Name: hussein Elkhayat, Assoc. Prof.; Phone Number: +201005549653; Email: elkhayat@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, +2088
    • Recruiting
    • Assiut University hospital
    • Contact: ali zein elabdein, MD; Phone Number: +201014566896; Email: ali_zein@aun.edu.eg
    • Contact: hussein Elkhayat, prof.; Phone Number: +201005549653; Email: elkhayat@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• pediatric patients 1 yrs. : ≤ 18 yrs.
• Patients with empyema due to pneumonia.
• Patients with empyema had lasted for fewer than 3 weeks.

Exclusion Criteria:

• Patients < 1 yrs. old.
• Patients with whom pleural empyema had lasted for more than 3 weeks.
• Patients with empyema had been caused by trauma.
• Patients whose parents refuse to be included in the study.
• Patients with empyema due to ruptured lung abscess.
• Patients with empyema due to chest wall abscess.
• Patients with empyema due to rib osteomyelitis.
• Patients with bronchopleural fistula.
• Patients with post-surgical empyema.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A (VATS); (group A) will receive VATS decortication as their definite management	Procedure: video assisted thoracoscopy (VATS); the investigators compare the outcomes of intervention by VATS and doing complete decortication or open surgery thoracotomy
Experimental: group B (open thoracotomy); (group B) will be assigned to open thoracotomy	Procedure: open thoracotomy; the investigators assess the outcomes of intervention by doing complete decortication through open surgery thoracotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound size	by centimeters	after 1week post operative
wound infection	which degree of infection or if there is a burst wound	during 1week post operative
hospital stay	by days post operative	1week post operative
air leak duration	by days and takes how many days to stop air leakage	during 1week post operative
Early mobilization.	how many days	during 1week post operative
pain score	through pain score scale 0 No Pain 1-3 Mild Pain (nagging, annoying) 4-6 Moderate Pain 7-10 Severe Pain (disabling)	during 1week post operative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chronic pain	presented or not	after 1month post operative
avoidance of scoliosis	which degree	after 1month post operative
shoulder muscle girdle weakness and deformity.	yes or no	after 1month post operative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Mohamed Ayyad, prof., Professor; Study Director: Mahmoud sallam, MD, doctor

Publications and helpful links

General Publications

• Arnold DT, Hamilton FW, Morris TT, Suri T, Morley A, Frost V, Vipond IB, Medford AR, Payne RA, Muir P, Maskell NA. Epidemiology of pleural empyema in English hospitals and the impact of influenza. Eur Respir J. 2021 Jun 17;57(6):2003546. doi: 10.1183/13993003.03546-2020. Print 2021 Jun.
• Krenke K, Urbankowska E, Urbankowski T, Lange J, Kulus M. Clinical characteristics of 323 children with parapneumonic pleural effusion and pleural empyema due to community acquired pneumonia. J Infect Chemother. 2016 May;22(5):292-7. doi: 10.1016/j.jiac.2016.01.016. Epub 2016 Feb 23.
• Shojaee S, Lee HJ. Thoracoscopy: medical versus surgical-in the management of pleural diseases. J Thorac Dis. 2015 Dec;7(Suppl 4):S339-51. doi: 10.3978/j.issn.2072-1439.2015.11.66.
• Bedawi EO, Hassan M, McCracken D, Rahman NM. Pleural infection: a closer look at the etiopathogenesis, microbiology and role of antibiotics. Expert Rev Respir Med. 2019 Apr;13(4):337-347. doi: 10.1080/17476348.2019.1578212. Epub 2019 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: pediatric empyema; VATS decortication
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Inflammation; Pleural Diseases; Suppuration; Empyema; Empyema, Pleural
• Other Study ID Numbers: 04-2024-100227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No