| Autor: |
Yuka Kadomatsu, Hiromu Yoshioka, Kikuo Shigemitsu, Yuji Nomata, Shunsuke Mori, Kyoko Hijiya, Hideki Motoyama, Yasuhisa Ichikawa, Kuniyo Sueyoshi, Toshiki Okasaka, Ei Miyamoto, Masashi Kobayashi, Mamoru Takahashi, Takuji Fujinaga, Hiroko Takechi, Hiroya Yamagishi, Teruhisa Takuwa, Jun Kobayashi, Jin Sakamoto, Tetsuo Taniguchi, Nobuharu Hanaoka, Yoko Kubo, Toyofumi F Chen-Yoshikawa |
| Rok vydání: |
2021 |
| Předmět: |
|
| Zdroj: |
BMJ Open |
| ISSN: |
2044-6055 |
| Popis: |
IntroductionThoracoscopic surgery is performed for refractory or recurrent primary spontaneous pneumothorax (PSP). To reduce postoperative recurrence, additional treatment is occasionally adopted during surgery after bulla resection. However, the most effective method has not been fully elucidated. Furthermore, the preference for additional treatment varies among countries, and its efficacy in preventing recurrence must be evaluated based on settings tailored for the conditions of a specific country. The number of registries collecting detailed data about PSP surgery is limited. Therefore, to address this issue, a prospective multicentre observational study was performed.Methods and analysisThis multicentre, prospective, observational study will enrol 450 participants aged between 16 and 40 years who initially underwent PSP surgery. Data about demographic characteristics, disease and family history, surgical details, and CT scan findings will be collected. Follow-up must be conducted until 3 years after surgery or in the event of recurrence, whichever came first. Patients without recurrence will undergo annual follow-up until 3 years after surgery. The primary outcome is the rate of recurrence within 2 years after surgery. A multivariate analysis will be performed to compare the efficacy of different surgical options. Then, adverse outcomes correlated with various treatments and the feasibility of treatment methods will be compared.Ethics and disseminationThis study was approved by the local ethics committee of all participating centres. The findings will be available in 2025, and they can be used as a basis for clinical decision-making regarding appropriate options for the initial PSP surgery.Trial registration numberNCT04758143. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
|
