Single Incision non-thoracoscopic Nuss procedure for children with pectus excavatum: protocol for a multicenter, non-masked, randomized controlled trial
BackgroundNuss procedure is the most common method of surgical treatment to pectus excavatum (PE). A significant percentage of surgeons choose to use thoracoscopic assistance during the Nuss procedure (TNP) to avoid cardiac injury. However, our previous findings confirm the safety of single incision...
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Frontiers Media S.A.
2023-07-01
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| Series: | Frontiers in Surgery |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fsurg.2023.1210452/full |
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| author | Quan Wang Quan Wang Zhengxia Pan Chun Wu Yonggang Li Gang Wang Jiangtao Dai Chunnian Ren Chunnian Ren Yiming Xie Liangjun Xiong Libing Zhang Hongbo Li Hongbo Li |
| author_facet | Quan Wang Quan Wang Zhengxia Pan Chun Wu Yonggang Li Gang Wang Jiangtao Dai Chunnian Ren Chunnian Ren Yiming Xie Liangjun Xiong Libing Zhang Hongbo Li Hongbo Li |
| author_sort | Quan Wang |
| collection | DOAJ |
| description | BackgroundNuss procedure is the most common method of surgical treatment to pectus excavatum (PE). A significant percentage of surgeons choose to use thoracoscopic assistance during the Nuss procedure (TNP) to avoid cardiac injury. However, our previous findings confirm the safety of single incision Non-thoracoscopic Nuss Procedure (SINTNP). Hence, Further studies, particularly prospective randomized controlled trials, are necessary to assess the value of SINTNP for PE.MethodsThis study is a prospective, superiority, multicenter, non-masked, randomized controlled trial that investigates the outcome and hospitalization medical expense of SINTNP compared to TNP for PE. A total of 320 eligible patients according to sample size calculation by retrospective data will be randomly assigned to the SINTNP group or the TNP group at a 1:1 ratio using stratified blocked randomization and the zone length was set as four. Patients aged between 3 and 18 years old for the first surgery and without combination of complex anomalies such as Marfan syndrome and congenital heart disease will be considered for the study. The co-primary endpoint is thoracic related complications and medical expense during hospitalization. Thoracic related complications were defined as pneumothorax, pleural effusion, pneumonia and incision infection. The secondary endpoints include surgery duration and length of hospital stay.The registration number for this study protocol is ChiCTR230073081 (Chinese Clinical Trial Registry, A Primary Registry of International Clinical Trial Registry Platform, World Health Organization). |
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| last_indexed | 2024-03-12T23:04:03Z |
| publishDate | 2023-07-01 |
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| series | Frontiers in Surgery |
| spelling | doaj.art-c8c1a437b7ff4ebdab8ed79c8cb4b7fd2023-07-19T06:39:11ZengFrontiers Media S.A.Frontiers in Surgery2296-875X2023-07-011010.3389/fsurg.2023.12104521210452Single Incision non-thoracoscopic Nuss procedure for children with pectus excavatum: protocol for a multicenter, non-masked, randomized controlled trialQuan Wang0Quan Wang1Zhengxia Pan2Chun Wu3Yonggang Li4Gang Wang5Jiangtao Dai6Chunnian Ren7Chunnian Ren8Yiming Xie9Liangjun Xiong10Libing Zhang11Hongbo Li12Hongbo Li13Department of Cardiothoracic Surgery, Ministry of Education Key Laboratory of Child Development and Disorders,National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, ChinaChongqing Key Laboratory of Pediatrics, Chongqing Medical University, Chongqing, ChinaDepartment of Cardiothoracic Surgery, Ministry of Education Key Laboratory of Child Development and Disorders,National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, ChinaDepartment of Cardiothoracic Surgery, Ministry of Education Key Laboratory of Child Development and Disorders,National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, ChinaDepartment of Cardiothoracic Surgery, Ministry of Education Key Laboratory of Child Development and Disorders,National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, ChinaDepartment of Cardiothoracic Surgery, Ministry of Education Key Laboratory of Child Development and Disorders,National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, ChinaDepartment of Cardiothoracic Surgery, Ministry of Education Key Laboratory of Child Development and Disorders,National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, ChinaDepartment of Cardiothoracic Surgery, Ministry of Education Key Laboratory of Child Development and Disorders,National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, ChinaChongqing Key Laboratory of Pediatrics, Chongqing Medical University, Chongqing, ChinaDepartment of Pediatric Surgery, Chongqing Three Gorges Central Hospital, Chongqing, ChinaDepartment of Pediatric Surgery, Qujing Maternal and Child Health Hospital, Qujing, ChinaDepartment of Pediatric Surgery, Chengdu Women and Children’s Central Hospital, Chengdu, ChinaDepartment of Cardiothoracic Surgery, Ministry of Education Key Laboratory of Child Development and Disorders,National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, ChinaChongqing Key Laboratory of Pediatrics, Chongqing Medical University, Chongqing, ChinaBackgroundNuss procedure is the most common method of surgical treatment to pectus excavatum (PE). A significant percentage of surgeons choose to use thoracoscopic assistance during the Nuss procedure (TNP) to avoid cardiac injury. However, our previous findings confirm the safety of single incision Non-thoracoscopic Nuss Procedure (SINTNP). Hence, Further studies, particularly prospective randomized controlled trials, are necessary to assess the value of SINTNP for PE.MethodsThis study is a prospective, superiority, multicenter, non-masked, randomized controlled trial that investigates the outcome and hospitalization medical expense of SINTNP compared to TNP for PE. A total of 320 eligible patients according to sample size calculation by retrospective data will be randomly assigned to the SINTNP group or the TNP group at a 1:1 ratio using stratified blocked randomization and the zone length was set as four. Patients aged between 3 and 18 years old for the first surgery and without combination of complex anomalies such as Marfan syndrome and congenital heart disease will be considered for the study. The co-primary endpoint is thoracic related complications and medical expense during hospitalization. Thoracic related complications were defined as pneumothorax, pleural effusion, pneumonia and incision infection. The secondary endpoints include surgery duration and length of hospital stay.The registration number for this study protocol is ChiCTR230073081 (Chinese Clinical Trial Registry, A Primary Registry of International Clinical Trial Registry Platform, World Health Organization).https://www.frontiersin.org/articles/10.3389/fsurg.2023.1210452/fullpectus excavatumsingle incisionNuss proceduremulticenterrandomized controlled trial |
| spellingShingle | Quan Wang Quan Wang Zhengxia Pan Chun Wu Yonggang Li Gang Wang Jiangtao Dai Chunnian Ren Chunnian Ren Yiming Xie Liangjun Xiong Libing Zhang Hongbo Li Hongbo Li Single Incision non-thoracoscopic Nuss procedure for children with pectus excavatum: protocol for a multicenter, non-masked, randomized controlled trial Frontiers in Surgery pectus excavatum single incision Nuss procedure multicenter randomized controlled trial |
| title | Single Incision non-thoracoscopic Nuss procedure for children with pectus excavatum: protocol for a multicenter, non-masked, randomized controlled trial |
| title_full | Single Incision non-thoracoscopic Nuss procedure for children with pectus excavatum: protocol for a multicenter, non-masked, randomized controlled trial |
| title_fullStr | Single Incision non-thoracoscopic Nuss procedure for children with pectus excavatum: protocol for a multicenter, non-masked, randomized controlled trial |
| title_full_unstemmed | Single Incision non-thoracoscopic Nuss procedure for children with pectus excavatum: protocol for a multicenter, non-masked, randomized controlled trial |
| title_short | Single Incision non-thoracoscopic Nuss procedure for children with pectus excavatum: protocol for a multicenter, non-masked, randomized controlled trial |
| title_sort | single incision non thoracoscopic nuss procedure for children with pectus excavatum protocol for a multicenter non masked randomized controlled trial |
| topic | pectus excavatum single incision Nuss procedure multicenter randomized controlled trial |
| url | https://www.frontiersin.org/articles/10.3389/fsurg.2023.1210452/full |
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