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A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial

文献类型：期刊论文

作者Wu, Xin7; Qiu, Ling7; Lou, Weihua6; Wang, Xipeng5; Zhu, Tao4; Zhang, Yuyang3; Hu, Weiguo7; Xue, Xiaohong7; Zhu, Zhiling7; Xiang, Libing2
刊名TRIALS
出版日期2022-04-08
卷号23
关键词Cervical cancer Stages IB1 IB2 and IIA1 Laparoscopic radical hysterectomy Abdominal radical hysterectomy Randomized controlled trials Progression-free survival Overall survival Prognosis
DOI10.1186/s13063-022-06245-5
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 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 (stages IB1, IB2, and IIA1) patient survival under stringent operation standards and consistent surgical oncologic principles. Methods/design: This is an investigator-initiated, Prospective, Randomized, Open, Blinded End-point (PROBE)-controlled non-inferiority trial. A total of 780 patients with stage IB1, IB2, and IIA1 cervical cancer will be enrolled over a period of 3 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 5 years. The primary endpoint will be 5-year progression-free survival, and secondary endpoints include 5-year overall survival, recurrence, and quality of life measurements. Discussion: The debate on laparoscopic versus abdominal RH is still ongoing, and high-quality evidences are needed to guide clinical practice. The study results will provide more convincing evidence-based information for early stage cervical cancer patients and their gynecologic cancer surgeons in their choice of surgical method.
WOS关键词MANAGEMENT ; STATISTICS ; 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Research & Experimental Medicine
语种英语
出版者BMC
WOS记录号WOS:000779599500005
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/334002/128723]  
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, Peoples R China
2.Fudan Univ, Zhongshan Hosp, Shanghai, Peoples R China
3.Wenzhou Med Univ, Affiliated Hosp 1, Wenzhou, Peoples R China
4.Univ Chinese Acad Sci, Canc Hosp, Zhejiang Canc Hosp, Hangzhou, Peoples R China
5.Shanghai Jiao Tong Univ, Xinhua Hosp, Sch Med, Shanghai, Peoples R China
6.Shanghai Jiao Tong Univ, Renji Hosp, Sch Med, Shanghai, 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,Qiu, Ling,Lou, Weihua,et al. A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial[J]. TRIALS,2022,23.
APA Wu, Xin.,Qiu, Ling.,Lou, Weihua.,Wang, Xipeng.,Zhu, Tao.,...&Jiang, Hua.(2022).A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial.TRIALS,23.
MLA Wu, Xin,et al."A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial".TRIALS 23(2022).

入库方式： OAI收割

来源：合肥物质科学研究院

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