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

doi:10.1186/s13063-022-06245-5

	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
	Wu, Xin 1; Qiu, Ling 1; Lou, Weihua 2; Wang, Xipeng 3; Zhu, Tao 4; Zhang, Yuyang 5; Hu, Weiguo 1; Xue, Xiaohong 1; Zhu, Zhiling 1; Xiang, Libing 6
刊名	TRIALS
	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
DOI	10.1186/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.
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关键词	MANAGEMENT ; STATISTICS ; GUIDELINES ; OUTCOMES
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
内容类型	期刊论文
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, Obstet & Gynecol Hosp, Shanghai 200011, Peoples R China 2.Shanghai Jiao Tong Univ, Renji Hosp, Sch Med, Shanghai, Peoples R China 3.Shanghai Jiao Tong Univ, Xinhua Hosp, Sch Med, Shanghai, Peoples R China 4.Univ Chinese Acad Sci, Canc Hosp, Zhejiang Canc Hosp, Hangzhou, Peoples R China 5.Wenzhou Med Univ, Affiliated Hosp 1, Wenzhou, Peoples R China 6.Fudan Univ, Zhongshan Hosp, Shanghai, Peoples R China 7.Fudan Univ, Childrens Hosp, Shanghai, 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).