## Protocol Section
### Identification Module
**NCT ID:** NCT06424457

**Acronym:** VATS

**Brief Title:** Pediatric Video Assisted Thoracoscopic Surgery (VATS) in Management of Empyema

**Official Title:** Video Assisted Thoracoscopic Surgery (VATS) Versus Thoracotomy in Management of Empyema in Pediatric Patients

#### Organization Study ID Info
**ID:** 04-2024-100227
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2026-04-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Ali zein elabdein abd elaleim

**Investigator Title:** Principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**Detailed Description:** comparison between VATS decortication and open thoracotomy in cases of pediatric empyema

### Conditions Module

**Conditions:**

- Thoracic Empyema

**Keywords:**

- pediatric empyema

- VATS decortication

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 73

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: video assisted thoracoscopy (VATS)

**Label:** group A (VATS)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** (group B) will be assigned to open thoracotomy

**Intervention Names:**

- Procedure: open thoracotomy

**Label:** group B (open thoracotomy)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- group A (VATS)

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

**Name:** video assisted thoracoscopy (VATS)

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- group B (open thoracotomy)

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

**Name:** open thoracotomy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** by centimeters

**Measure:** wound size

**Time Frame:** after 1week post operative

**Description:** which degree of infection or if there is a burst wound

**Measure:** wound infection

**Time Frame:** during 1week post operative

**Description:** by days post operative

**Measure:** hospital stay

**Time Frame:** 1week post operative

**Description:** by days and takes how many days to stop air leakage

**Measure:** air leak duration

**Time Frame:** during 1week post operative

**Description:** through pain score scale 0 No Pain 1-3 Mild Pain (nagging, annoying) 4-6 Moderate Pain 7-10 Severe Pain (disabling)

**Measure:** pain score

**Time Frame:** during 1week post operative.

**Description:** how many days

**Measure:** Early mobilization.

**Time Frame:** during 1week post operative

#### Secondary Outcomes

**Description:** presented or not

**Measure:** chronic pain

**Time Frame:** after 1month post operative

**Description:** which degree

**Measure:** avoidance of scoliosis

**Time Frame:** after 1month post operative

**Description:** yes or no

**Measure:** shoulder muscle girdle weakness and deformity.

**Time Frame:** after 1month post operative

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 18 Years

**Minimum Age:** 1 Year

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ali_zein@aun.edu.eg

**Name:** ali zein eladein, Ass.Lect.

**Phone:** +201014566896

**Role:** CONTACT

**Contact 2:**

**Email:** elkhayat@aun.edu.eg

**Name:** hussein Elkhayat, Assoc. Prof.

**Phone:** +201005549653

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Assiut

**Contacts:**

***Contact 1:***

- **Email:** ali_zein@aun.edu.eg

- **Name:** ali zein elabdein, MD

- **Phone:** +201014566896

- **Role:** CONTACT

***Contact 2:***

- **Email:** elkhayat@aun.edu.eg

- **Name:** hussein Elkhayat, prof.

- **Phone:** +201005549653

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Assiut University Hospital

**Status:** RECRUITING

**Zip:** +2088

#### Overall Officials

**Official 1:**

**Affiliation:** professor

**Name:** Mohamed Ayyad, prof.

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** doctor

**Name:** Mahmoud sallam, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013492

- Term: Suppuration

- ID: D000007239

- Term: Infections

- ID: D000007249

- Term: Inflammation

- ID: D000010335

- Term: Pathologic Processes

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000010995

- Term: Pleural Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M7819

- Name: Empyema

- Relevance: HIGH

- As Found: Empyema

- ID: M19086

- Name: Empyema, Pleural

- Relevance: HIGH

- As Found: Thoracic Empyema

- ID: M16273

- Name: Suppuration

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13885

- Name: Pleural Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004653

- Term: Empyema

- ID: D000016724

- Term: Empyema, Pleural

### Misc Info Module

- Version Holder: 2024-05-31
