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A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IA1 with LVSI, IA2): study protocol of the LAUNCH 1 trial

文献类型：期刊论文

作者Wu, Xin7; Feng, Hao7; Gao, Shujun7; Feng, Hua7; Diao, Wenjing7; Zhang, Hongwei7; Du, Ming7; Lou, Weihua6; Wang, Xipeng5; Zhu, Tao4
刊名BMC CANCER
出版日期2022-04-09
卷号22
关键词Cervical cancer Stage IA1 with LVSI and IA2 Laparoscopic radical hysterectomy Abdominal radical hysterectomy Progression-free survival Overall survival Prognosis
DOI10.1186/s12885-022-09494-4
通讯作者Du, Yan(sophiedu_61@163.com) ; Jiang, Hua(jianghua@fudan.edu.cn)
英文摘要Background: A retrospective study and a randomized controlled trial published in a high quality journal in late 2018 have shown that laparoscopic radical hysterectomy (RH) was associated with worse survival than abdominal RH among patients with early stage cervical cancer. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology, therefore this conclusion is pivotal. The current trial is designed to reconfirm whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stage IA1 with LVSI, IA2) patient survival under stringent operation standards and consistent tumor-free technique. This paper reports the rationale, design, and implementation of the trial. Methods: This is an investigator-initiated, prospective, randomized, open, blinded endpoint (PROBE) controlled trial. A total of 690 patients with stage IA1 (with intravascular), and IA2 cervical cancer will be enrolled over a period of three years. Patients are randomized (1:1) to either the laparoscopic RH or the abdominal RH group. Patients will then be followed-up for at least five years. The primary endpoint will be 5-year progression-free survival. Secondary endpoints will include 5-year overall survival rates, recurrence rates, operation time, intraoperative blood loss, surgery-related complications, and quality of life. Discussion: The results of the trial will provide valuable evidence for guiding clinical decision of choosing appropriate treatment strategies for stage IA1 (LVSI) and stage IA2 cervical cancer patients.
WOS关键词MANAGEMENT ; GUIDELINES ; OUTCOMES
资助项目Shanghai Shenkang Hospital Development Center's Shenkang Promotion of Clinical Skills and Clinical Innovation in Municipal Hospitals Three-Year Action Plan (2020-2023) Major Clinical Research Project[SHDC2020CR1048B]
WOS研究方向Oncology
语种英语
出版者BMC
WOS记录号WOS:000781372200008
资助机构Shanghai Shenkang Hospital Development Center's Shenkang Promotion of Clinical Skills and Clinical Innovation in Municipal Hospitals Three-Year Action Plan (2020-2023) Major Clinical Research Project
源URL[http://ir.hfcas.ac.cn:8080/handle/334002/128525]  
专题中国科学院合肥物质科学研究院
通讯作者Du, Yan; Jiang, Hua
作者单位1.Fudan Univ, Childrens Hosp, Shanghai 201102, Peoples R China
2.Fudan Univ, Zhongshan Hosp, Shanghai 200032, Peoples R China
3.Wenzhou Med Univ, Affiliated Hosp 1, Wenzhou 325000, Peoples R China
4.Univ Chinese Acad Sci, Canc Hosp, Zhejiang Canc Hosp, Hangzhou 310005, Peoples R China
5.Shanghai Jiao Tong Univ, Xinhua Hosp, Sch Med, Shanghai 200092, Peoples R China
6.Shanghai Jiao Tong Univ, Renji Hosp, Sch Med, Shanghai 200127, Peoples R China
7.Fudan Univ, Obstet & Gynecol Hosp, Shanghai 200011, Peoples R China
推荐引用方式
GB/T 7714		 Wu, Xin,Feng, Hao,Gao, Shujun,et al. A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IA1 with LVSI, IA2): study protocol of the LAUNCH 1 trial[J]. BMC CANCER,2022,22.
APA Wu, Xin.,Feng, Hao.,Gao, Shujun.,Feng, Hua.,Diao, Wenjing.,...&Jiang, Hua.(2022).A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IA1 with LVSI, IA2): study protocol of the LAUNCH 1 trial.BMC CANCER,22.
MLA Wu, Xin,et al."A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IA1 with LVSI, IA2): study protocol of the LAUNCH 1 trial".BMC CANCER 22(2022).

入库方式： OAI收割

来源：合肥物质科学研究院

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