期刊
TRIALS
卷 23, 期 1, 页码 -出版社
BMC
DOI: 10.1186/s13063-022-06245-5
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
资金
- 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]
This study aims to compare laparoscopic radical hysterectomy and abdominal radical hysterectomy in terms of survival rates among patients with early-stage cervical cancer. The results of this study are of great significance in guiding clinical practice.
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.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据