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Study protocol of radical hysterectomy
时间:2019.08.03
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作者:Xiaopei Chao, Lei Li, Ming Wu, et al
来源:本站原创

This study protocol has been published in BMJ Open. 2019;9(7):e029055. 

Link is:/Uploads/Picture/2019/08/03/u5d4535f776948.pdf



Title

The efficacy of different surgical approaches in the clinical and survival outcomes of patients with early-stage cervical cancer: The protocol of a phase 3 multicenter randomized controlled trial in China


Short title

Surgical approaches to the survival from early-stage cervical cancer


Authors

Xiaopei Chao, M.D.,1 xy7cxp@163.com

Lei Li, M.D.,1* lileigh@163.com

Ming Wu, M.D.,1 wuming@pumch.cn

Shuiqing Ma, M.D.,1 mashuiqing1964@163.com

Xianjie Tan, M.D.,1 tanxj_pumch@163.com

Sen Zhong, M.D.,1 pumchzhongsen@163.com

Jinghe Lang, M.D.,1 langjh@hotmail.com

Aoshuang Cheng, M.D.,1 371471648@qq.com

Wenhui Li, M.D.,1 liwenhui1025@163.com

Affiliations

1Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing 100730, China

*Corresponding authors

Lei Li, M.D.

Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science

Address: Shuaifuyuan No. 1, Dongcheng District, Beijing 100730, China

Email: lileigh@163.com (LL)

Phone: 86-139-1198-8831



ABSTRACT

Introduction

In the last three decades, minimally invasive surgery (MIS) for radical hysterectomy (RH) has become a popular treatment option for early-stage cervical cancer. However, a recently published randomized controlled trial (LACC trial) and an epidemiological study in the United States revealed strong evidence against the survival advantage of MIS for RH. However, the influencing factors of research centers and the learning curves of surgeons in these studies lacked sufficient evaluation. The efficacy of different surgical approaches for early-stage cervical cancer in the clinical and survival outcomes remains to be validated.

Methods and analysis

Patients diagnosed with FIGO (2009) stage IA1 (with lymphovascular space invasion), IA2 or IB1 cervical cancer with histological subtype of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma will be recruited in this multicenter randomized controlled study. Patients will be randomly assigned to undergo MIS (robot-assisted or laparoscopic RH) or abdominal RH. Within two years, 1448 patients in 28 centers in China will be recruited to meet the criteria of a non-inferiority threshold of hazard ratio of 1.6 with bilateral nominal α <0.05 and power of 0.8. All surgeries will be performed by the indicated experienced surgeons. At least 100 RH cases in the individual past one decade of practice will be analyzed as proof of learning curves. The primary objective of this study is 5-year disease-free survival. The secondary objectives include the overall survival rate, progression-free survival rate, disease-free survival rate, cost-effectiveness, and quality of life.

Ethics and dissemination

This study has been approved by the Institutional Review Board of Peking Union Medical College Hospital and is filed on record by all other centers. The registration number is NCT03739944. Written informed consent will be obtained from all eligible participants before enrollment. The results will be disseminated through community events, academic conferences, student theses, and peer-reviewed journals.

Trial registration number

NCT03739944.

Key words

cervical cancer; laparoscopy; abdominal surgery; disease-free survival; learning curve; radical hysterectomy