Effect of Dissecting of The Inferior Pulmonary Ligament on Postoperative Pulmonary Reexpansion and Recurrence

Chinese Medical Association

Status and phase: Unknown; Phase 3

Conditions: Pneumothorax

Treatments: Procedure: thoracoscopic surgery; Procedure: WR; Procedure: DIPL

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02558608

FPL001

Details and patient eligibility

About

This subject analysis of the influence of the dissociating inferior pulmonary ligament on pulmonary reexpansion and recurrence in the treatment of primary spontaneous pneumothorax by video assisted thoracic surgery. All patients are randomly divided into two groups: group A and group B. Wedge resection(WR) will be performed for all patients. Investigators dissect the inferior pulmonary ligament(DIPL) for group A. Investigators do not dissect the inferior pulmonary ligament for group B. The pulmonary reexpansion and recurrence rate are observed between the two groups.

Full description

Wedge resection of the lung is usually used in the treatment of primary spontaneous pneumothorax. And the pleural treatment also might be used. But part of secondary pneumothorax patients who had undergone surgical, the bullae can be found especially in the apical of lung, even if the pleural have been treated in some way.This subject provides a new way of thinking and method to solve the problem of recurrent spontaneous pneumothorax.

Enrollment: 260 estimated patients

Sex: All

Ages: 10 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patients diagnosis pneumothorax with chest radiograph or computed tomography (CT)
2. The clinical and final pathological diagnosis for patient is PSP.
3. The patients with stable vital signs, no contraindication for operation and no communication barriers.
4. The patients,after informed of test content, significance and risk, who voluntarily enroll and sign informed consent.

Exclusion criteria

1. The patients who refuse to do a video assisted thoracic surgery.
2. The patients with pneumothorax with specific causes such as pulmonary hamartoangiomyomatosis, catamenial pneumothorax, and pneumothorax secondary to chronic obstructive pulmonary disease.
3. The patients who were older than 50 years
4. The patients with familial history of pneumothorax.
5. The patients with mental disorders, low Intelligence Quotient, can not objectively reflect the indicators of observation.
6. The patients who refuse to follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

WR AND DIPL

Experimental group

Description:

patients undergo wedge resection and dissection the inferior pulmonary ligament by thoracoscopic surgery or video assisted thoracoscopic surgery

Treatment:

Procedure: DIPL

Procedure: thoracoscopic surgery

Procedure: WR

WR

Active Comparator group

Description:

patients undergo wedge resection by thoracoscopic surgery or video assisted thoracoscopic surgery without dissection the inferior pulmonary ligament

Treatment:

Procedure: thoracoscopic surgery

Procedure: WR