Most Preventable Surgical Option to Reduce Primary Spontaneous Pneumothorax Patients' Postoperative Recurrence: A Prospective Cohort Study

Recruiting

• Conditions: Recurrence; Spontaneous Pneumothorax; Surgery

• Registration Number: NCT04758143
• Lead Sponsor: Yuka Kadomatsu

Brief Summary

To investigate the most preventable option to reduce primary spontaneous postoperative recurrence.

Detailed Description

Pneumothorax is a disease in which air in the lungs leaks into the pleural cavity. It is a disease that occurs most often in young people with active social activities, and it occurs in about 100,000 people in 14 cases. The recurrence rate is as high as 17% to 54%, and the delay of the rehabilitation by the ambulatory with the treatment and prolongation of the hospitalization becomes a problem. It becomes a large failure for the youth who requires early rehabilitation. According to the latest report from the Japanese Society of Surgery, approximately 12,000 pneumothorax surgeries are performed annually in Japan. Many of them applied absorbent material to the surgical stump (coverage technique). However, there are no prospective studies, and efficacy does not appear adequately tested. It is necessary to accumulate prospective data from multiple centers to investigate the coverage technique's real effect.

Study Timeline

• Study Start: 2020-08-11
• Status Verified: 2021-02
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-16
• Study First Posted: 2021-02-17
• Last Update Posted: 2021-02-18
• Primary Completion: 2022-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Patients who have spontaneous pneumothorax diagnosed by radiography and plan to underwent initial VATS bullectomy.
2. Patients who receive informed consent to attend this study, and the agreements are provided in a document.

The consent of parents is also required, in case patients are under 20-years old.

Exclusion Criteria

1. History of ipsilateral chest surgery.
2. Patients who only underwent exploratory surgery.
3. Patients who are judged ineligible by the investigator and the attending surgeon.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence rate of pneumothorax	within 2 years after the surgery	Rate of ipsilateral pneumothorax recurrence detected by radiography at two years after surgery

Trial Locations

Locations (1)

Department of Thoracic Surgery, Nagoya University Graduate School of Medicine; 🇯🇵 Nagoya, Japan