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

NCT06424457 | Recruiting

• 1 other identifier: 04-2024-100227
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thoracic Empyema

Keywords

pediatric empyema; VATS decortication

Outcome Measures

Primary Outcomes (6)

• 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

• 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.

• Early mobilization.

  how many days

  during 1week post operative

Secondary Outcomes (3)

• chronic pain

  after 1month post operative

• avoidance of scoliosis

  after 1month post operative

• shoulder muscle girdle weakness and deformity.

  after 1month post operative

Study Arms (2)

group A (VATS)

EXPERIMENTAL

(group A) will receive VATS decortication as their definite management

Procedure: video assisted thoracoscopy (VATS)

group B (open thoracotomy)

EXPERIMENTAL

(group B) will be assigned to open thoracotomy

Procedure: open thoracotomy

Interventions

video assisted thoracoscopy (VATS) PROCEDURE

the investigators compare the outcomes of intervention by VATS and doing complete decortication or open surgery thoracotomy

group A (VATS)

open thoracotomy PROCEDURE

the investigators assess the outcomes of intervention by doing complete decortication through open surgery thoracotomy

group B (open thoracotomy)

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, +2088, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 33334937 BACKGROUND

• 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.

  PMID: 26919911 BACKGROUND

• 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.

  PMID: 26807282 BACKGROUND

• 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.

  PMID: 30707629 BACKGROUND

MeSH Terms

Conditions

Empyema, Pleural

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Empyema; Suppuration; Pleural Diseases; Respiratory Tract Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Mohamed Ayyad, prof.

  professor

  STUDY DIRECTOR

• Mahmoud sallam, MD

  doctor

  STUDY DIRECTOR

Central Study Contacts

ali zein eladein, Ass.Lect.

CONTACT

+201014566896; ali_zein@aun.edu.eg

hussein Elkhayat, Assoc. Prof.

CONTACT

+201005549653; elkhayat@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)