VATS Evacuation Compared to Reinsertion of Thoracostomy Tube in Persistent Traumatic Haemothorax

NCT03501524 | Completed DMC

• 1 other identifier: 17100227
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is prospective, randomized study comparing VATS (video- Assisted Thoracoscopy) to reinsertion of a thoracostomy tube in patients with persistent traumatic haemothorax. The incidence varies and can be as high as 20%, but in most studies is found to be 1-4% after initial tube thoracostomy for chest trauma. The most accepted complication of retained hemothorax is empyema.Retained hemothorax treatment started by physiotherapy and early withdrawal of tube thoracostomy which lead to more complications as empyema, fibro thorax/entrapped lung, flail chest and diaphragmatic hernia. Early VATS is an alternative treatment for retained hemothorax with evidence that it is a superior intervention when compared to a second tube thoracostomy.

Conditions

Hemothorax; Traumatic

Outcome Measures

Primary Outcomes (1)

• Duration of hospitalization

  number of days spent

  average 5-7 days

Secondary Outcomes (1)

• number of patients developed empyema

  through one month

Study Arms (2)

VATS evacuation

EXPERIMENTAL

patients selected for VATS after failure of first thoracostomy tube drainage

Device: VATS evacuation; Device: thoracostomy tube

thoracostomy tube

EXPERIMENTAL

patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube

Device: VATS evacuation; Device: thoracostomy tube

Interventions

VATS evacuation DEVICE

the patient will be randomized to a Video-Assisted thoracoscopy for retained haemothorax

VATS evacuation; thoracostomy tube

thoracostomy tube DEVICE

the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax

Also known as: intercostal tube reinsertion

VATS evacuation; thoracostomy tube

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• We include for the study all patients admitted to Assiut university hospitals during the time of the study that proved persistent haemothorax that with criteria:
• Ages that are eligible for study are between 18years to 60 years (adult)
• Both genders will be included to study.
• Clinical and radiological diagnosis of persistent haemothorax.
• Thoracostomy tube blockage or failure to drain within 5-7days.

You may not qualify if:

• More than one thoracostomy tube drainage in the same attempt side.
• Unable to consent to trial.
• Coexisting pathology requiring other interventions.
• Patients that need urgent interventions (hemodynamically unstable, empyema and flail chest).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

MeSH Terms

Conditions

Hemothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammed Khalil salama Ayyad, PHD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: April 18, 2018
• Study Start: July 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

EG (1)