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

Phase 3

• Conditions: Pneumothorax
• Interventions: Procedure: WR; Procedure: DIPL; Procedure: thoracoscopic surgery

• Registration Number: NCT02558608
• Lead Sponsor: Chinese Medical Association

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-09-13
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-24
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-14
• Last Update Posted: 2015-10-16
• Primary Completion: 2018-12
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WR	WR	patients undergo wedge resection by thoracoscopic surgery or video assisted thoracoscopic surgery without dissection the inferior pulmonary ligament
WR AND DIPL	thoracoscopic surgery	patients undergo wedge resection and dissection the inferior pulmonary ligament by thoracoscopic surgery or video assisted thoracoscopic surgery
WR AND DIPL	DIPL	patients undergo wedge resection and dissection the inferior pulmonary ligament by thoracoscopic surgery or video assisted thoracoscopic surgery
WR AND DIPL	WR	patients undergo wedge resection and dissection the inferior pulmonary ligament by thoracoscopic surgery or video assisted thoracoscopic surgery
WR	thoracoscopic surgery	patients undergo wedge resection by thoracoscopic surgery or video assisted thoracoscopic surgery without dissection the inferior pulmonary ligament

Primary Outcome Measures

Name	Time	Method
recurrence rate	3 years	the 3- year recurrence rate of pneumothorax after surgery.

Secondary Outcome Measures

Name	Time	Method
pulmonary reexpansion rate	1 day and 4 days	the proportion of pulmonary reexpansion on the first and fourth day after operation.

Trial Locations

Locations (1)

Beijing Haidian Hospital; 🇨🇳 Beijing, Beijing, China