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

NCT ID: NCT04758143

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-11
• Study Completion Date: 2025-03-31

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.

Conditions

Spontaneous Pneumothorax; Recurrence; Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuka Kadomatsu

OTHER

Sponsor Role: lead

Responsible Party

Yuka Kadomatsu

Subinvestigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Toyofumi Chen-Yoshikawa, PhD

Role: STUDY_DIRECTOR

Department of Thoracic Surgery, Nagoya University Graduate Scho

Locations

Department of Thoracic Surgery, Nagoya University Graduate School of Medicine

Nagoya, , Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Yuka Kadomatsu, MD

Role: CONTACT

ykadoamtsu@med.nagoya-u.ac.jp

+81-52-744-2375

Toyofumi Chen-Yoshikawa, PhD

Role: CONTACT

tyoshikawa@med.nagoya-u.ac.jp

+81-52-744-2375

Facility Contacts

Yuka Kadomatsu, MD

Role: primary

ykadomatsu@med.nagoya-u.ac.jp

+81-52-744-2375

Toyofumi Chen-Yoshikawa, PhD

Role: backup

tyoshikawa@med.nagoya-u.ac.jp

+81-52-744-2375

References

Kadomatsu Y, Yoshioka H, Shigemitsu K, Nomata Y, Mori S, Hijiya K, Motoyama H, Ichikawa Y, Sueyoshi K, Okasaka T, Miyamoto E, Kobayashi M, Takahashi M, Fujinaga T, Takechi H, Yamagishi H, Takuwa T, Kobayashi J, Sakamoto J, Taniguchi T, Hanaoka N, Kubo Y, Chen-Yoshikawa TF. Multicentre, prospective, observational study investigating the most appropriate surgical option that can prevent the recurrence of primary spontaneous pneumothorax after surgery: the PATCH study, protocol. BMJ Open. 2021 Dec 20;11(12):e052045. doi: 10.1136/bmjopen-2021-052045.

Reference Type: DERIVED

PMID: 34930734 (View on PubMed)

Other Identifiers

2020-0164 20274

Identifier Type: -

Identifier Source: org_study_id