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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pneumothorax

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WR AND DIPL

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

Group Type EXPERIMENTAL

DIPL

Intervention Type PROCEDURE

dissection of the inferior pulmonary ligament

WR

Intervention Type PROCEDURE

wedge resection of the lung bleb

thoracoscopic surgery

Intervention Type PROCEDURE

surgery performed by video assisted thoracoscopy

WR

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

Group Type ACTIVE_COMPARATOR

WR

Intervention Type PROCEDURE

wedge resection of the lung bleb

thoracoscopic surgery

Intervention Type PROCEDURE

surgery performed by video assisted thoracoscopy

Interventions

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DIPL

dissection of the inferior pulmonary ligament

Intervention Type PROCEDURE

WR

wedge resection of the lung bleb

Intervention Type PROCEDURE

thoracoscopic surgery

surgery performed by video assisted thoracoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No