"Single Incision non-thoracoscopic Nuss procedure for children with pectus excavatum: protocol for a multicenter, non-masked, randomized controlled trial"

作者全名："Wang, Quan; Pan, Zhengxia; Wu, Chun; Li, Yonggang; Wang, Gang; Dai, Jiangtao; Ren, Chunnian; Xie, Yiming; Xiong, Liangjun; Zhang, Libing; Li, Hongbo"

作者地址："[Wang, Quan; Pan, Zhengxia; Wu, Chun; Li, Yonggang; Wang, Gang; Dai, Jiangtao; Ren, Chunnian; Li, Hongbo] Chongqing Med Univ, Childrens Hosp, Natl Clin Res Ctr Child Hlth & Disorders, China Int Sci & Technol Cooperat Base Child Dev &, Chongqing, Peoples R China; [Wang, Quan; Ren, Chunnian; Li, Hongbo] Chongqing Med Univ, Chongqing Key Lab Pediat, Chongqing, Peoples R China; [Zhang, Libing] Chengdu Women & Childrens Cent Hosp, Dept Pediat Surg, Chengdu, Peoples R China; [Xie, Yiming] Chongqing Three Gorges Cent Hosp, Dept Pediat Surg, Chongqing, Peoples R China; [Xiong, Liangjun] Qujing Maternal & Child Hlth Hosp, Dept Pediat Surg, Qujing, Peoples R China"

通信作者："Li, HB (通讯作者)，Chongqing Med Univ, Childrens Hosp, Natl Clin Res Ctr Child Hlth & Disorders, China Int Sci & Technol Cooperat Base Child Dev &, Chongqing, Peoples R China.; Li, HB (通讯作者)，Chongqing Med Univ, Chongqing Key Lab Pediat, Chongqing, Peoples R China.; Zhang, LB (通讯作者)，Chengdu Women & Childrens Cent Hosp, Dept Pediat Surg, Chengdu, Peoples R China.; Xie, YM (通讯作者)，Chongqing Three Gorges Cent Hosp, Dept Pediat Surg, Chongqing, Peoples R China.; Xiong, LJ (通讯作者)，Qujing Maternal & Child Hlth Hosp, Dept Pediat Surg, Qujing, Peoples R China."

来源：FRONTIERS IN SURGERY

ESI学科分类：　

WOS号：WOS:001040988400001

JCR分区：Q2

影响因子：1.6

年份：2023

卷号：10

期号：　

开始页：　

结束页：　

文献类型：Article

关键词：pectus excavatum; single incision; Nuss procedure; multicenter; randomized controlled trial

摘要："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)."

基金机构：Chongqing Science and Health Joint Project [2023MSXM070]; National Children's Health and Disease Clinical Medicine Research Centre [NCRCCHD-2021-YP-17]

基金资助正文：& nbsp;This study was supported by Chongqing Science and Health Joint Project (No. 2023MSXM070) the youth program of clinical medicine research of National Children's Health and Disease Clinical Medicine Research Centre (No. NCRCCHD-2021-YP-17).