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

Sponsor
Yuka Kadomatsu (Other)
Overall Status
Recruiting
CT.gov ID
NCT04758143
Collaborator
(none)
450
Enrollment
1
Location
55.6
Anticipated Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    450 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Most Preventable Surgical Option to Reduce Primary Spontaneous Pneumothorax Patients' Postoperative Recurrence: A Prospective Cohort Study
    Actual Study Start Date :
    Aug 11, 2020
    Anticipated Primary Completion Date :
    Mar 31, 2022
    Anticipated Study Completion Date :
    Mar 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Recurrence rate of pneumothorax [within 2 years after the surgery]

      Rate of ipsilateral pneumothorax recurrence detected by radiography at two years after surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Thoracic Surgery, Nagoya University Graduate School of Medicine Nagoya Japan 466-8550

    Sponsors and Collaborators

    • Yuka Kadomatsu

    Investigators

    • Study Director: Toyofumi Chen-Yoshikawa, PhD, Department of Thoracic Surgery, Nagoya University Graduate Scho

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuka Kadomatsu, Subinvestigator, Nagoya University
    ClinicalTrials.gov Identifier:
    NCT04758143
    Other Study ID Numbers:
    • 2020-0164 20274
    First Posted:
    Feb 17, 2021
    Last Update Posted:
    Feb 18, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pneumothorax
    Recurrence

    Study Results

    No Results Posted as of Feb 18, 2021