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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758143
• Other study ID #: 2020-0164 20274
• Status: Recruiting
• Start date: August 11, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2021
• Source: Nagoya University
• Contact: Yuka Kadomatsu, MD
• Phone: +81-52-744-2375
• Email: ykadoamtsu[@]med.nagoya-u.ac.jp
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumothorax
• Recurrence
• Spontaneous Pneumothorax
• Surgery

Locations

Country	Name	City	State
Japan	Department of Thoracic Surgery, Nagoya University Graduate School of Medicine	Nagoya

Sponsors (1)

Lead Sponsor	Collaborator
Yuka Kadomatsu

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate of pneumothorax	Rate of ipsilateral pneumothorax recurrence detected by radiography at two years after surgery	within 2 years after the surgery