Comparison of the survival outcomes of laparoscopic, abdominal and gasless laparoscopic radical hysterectomy for early-stage cervical cancer: trial protocol of a multicenter randomized controlled trial (LAGCC trial)

Xiaoyan Tang; Shan Zhou; Xuyin Zhang; Keqin Hua; Yuan He; Ping Wang; Yincheng Teng; Weiwei Feng

doi:10.3389/fonc.2023.1287697

Comparison of the survival outcomes of laparoscopic, abdominal and gasless laparoscopic radical hysterectomy for early-stage cervical cancer: trial protocol of a multicenter randomized controlled trial (LAGCC trial)

Front Oncol. 2023 Nov 13:13:1287697. doi: 10.3389/fonc.2023.1287697. eCollection 2023.

Authors

Xiaoyan Tang^#¹, Shan Zhou^#¹, Xuyin Zhang¹, Keqin Hua¹, Yuan He², Ping Wang³, Yincheng Teng⁴, Weiwei Feng⁵

Affiliations

¹ Department of Gynecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.
² Office of Clinical Epidemiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.
³ Department of Gynecology and Obstetrics, West China Second University Hospital, Sichuan University, Sichuan, China.
⁴ Department of Gynecology and Obstetrics, Shanghai Sixth People Hospital, Shanghai Jiaotong University, Shanghai, China.
⁵ Department of Gynecology and Obstetrics, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.

^# Contributed equally.

Abstract

Background: Radical hysterectomy (RH) is considered a cornerstone in the treatment of early-stage cervical cancer. However, the debate surrounding the optimal surgical approach, whether minimally invasive or open surgery, remains controversial. The objective of this trial is to evaluate the survival outcomes of cervical cancer patients who undergo different surgical approaches.

Methods: This study is designed as a prospective, multicenter, open, parallel, and randomized controlled trial. A total of 500 patients diagnosed with stage IA1 with LVSI, IA2, IB1, or IB2 (2018 FIGO) will be recruited. Recruitment of participants started in November 2020. The participants will be randomly assigned to one of three groups: conventional laparoscopic RH, gasless laparoscopic RH, or abdominal RH. The primary endpoint of this trial is the 2-year disease-free survival (DFS) rate. The secondary endpoints will include the 2-year overall survival (OS) rate, 5-year DFS/OS, recurrence rates, operation time, intraoperative blood loss, surgery-related complications, and impact on quality of life (QoL).

Discussion: We expect this trial to provide compelling and high-quality evidence to guide the selection of the most appropriate surgical approach for early-stage cervical cancer.

Clinical trial registration: Chinese Clinical Trial Register, identifier ChiCTR2000035515.

Keywords: abdominal radical hysterectomy; cervical cancer; disease-free survival; gasless laparoscopic radical hysterectomy; laparoscopic radical hysterectomy; overall survival; tumor-free principle.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. The research is supported by funding of Clinical Research Plan of Shanghai shen kang Hospital Development Center (grant No. SHDC2020CR1045B and No. SHDC2020CR6009) and Science and Technology Innovation Plan of Shanghai Science and Technology Committee (22Y31900500). The sponsors had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript nor do they have ultimate authority over any of these action.