{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T00:41:02Z","timestamp":1760834462015,"version":"build-2065373602"},"reference-count":12,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2021,12,19]],"date-time":"2021-12-19T00:00:00Z","timestamp":1639872000000},"content-version":"unspecified","delay-in-days":18,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,11,18]]},"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Thoracoscopic 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>This 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>This 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04758143\">NCT04758143<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-052045","type":"journal-article","created":{"date-parts":[[2021,12,20]],"date-time":"2021-12-20T13:32:26Z","timestamp":1640007146000},"page":"e052045","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["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"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct04758143","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3045-9475","authenticated-orcid":false,"given":"Yuka","family":"Kadomatsu","sequence":"first","affiliation":[{"name":"Department of Thoracic Surgery, Nagoya University, Nagoya, Aichi, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiromu","family":"Yoshioka","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Aichi, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kikuo","family":"Shigemitsu","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Ogaki Municipal Hospital, Ogaki, Gifu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuji","family":"Nomata","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Toyohashi Municipal Hospital, Toyohashi, Aichi, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shunsuke","family":"Mori","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Yokkaichi Municipal Hospital, Yokkaichi, Mie, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyoko","family":"Hijiya","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Shizuoka City Shizuoka Hospital, Shizuoka, Shizuoka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideki","family":"Motoyama","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Kobe City Nishi-Kobe Medical Center, Kobe, Hyogo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuhisa","family":"Ichikawa","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Aichi, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kuniyo","family":"Sueyoshi","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, St. Luke\"s International Hospital, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshiki","family":"Okasaka","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Toyota Kosei Hospital, Toyota, Aichi, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ei","family":"Miyamoto","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Tenri Hospital, Tenri, Nara, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masashi","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Kurashiki Central Hospital, Kurashiki, Okayama, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mamoru","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Kyoto Katsura Hospital, Kyoto, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takuji","family":"Fujinaga","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, National Hospital Organization Nagara Medical Center, Gifu, Gifu, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroko","family":"Takechi","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Hyogo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroya","family":"Yamagishi","sequence":"additional","affiliation":[{"name":"Department of Chest Surgery, Japanese Red Cross Fukui Hospital, Fukui, Fukui, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teruhisa","family":"Takuwa","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Osakafu Saiseikai Noe Hospital, Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Shimada Municipal Hospital, Shimada, Shizuoka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jin","family":"Sakamoto","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Shimane Prefectural Central Hospital, Izumo, Shimane, 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