Comparison Between Laparoscopic Radical Hysterectomy Based on Space Anatomy and Abdominal Radical Hysterectomy for Stage IB3 and IIA2 Cervical Cancer: a Multicenter Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- Overall survival
研究概览
简要总结
Radical hysterectomy is an effect treatment for FIGO IB3 and IIA2 cervical cancer patients who refuse to receive radical concurrent chemoradiotherapy. However, due to the large tumor size, both patients and surgeons encountered the risk of substantial bleeding, urinary tract damage, and unsatisfactory resection during surgery. Therefore, the exploration of effective and safe surgical treatments is crucial in enhancing the quality of life and prognosis for patients. Laparoscopic radical hysterectomy (LRH) offers the advantages of reduced bleeding and accelerated recovery, thereby minimizing patient discomfort and enhancing their quality of life. However, the prognosis of patients who received LRH or traditional abdominal radical hysterectomy (ARH) remains controversial. We proposed a modified LRH skill based on new space anatomy concept. In our previous single-center study, the result demonstrates that LRH based on space anatomy leads to less intraoperative blood loss and decreased ureteral injury rate compared with traditional skill. The benefits of this new method for patient survival remain uncertain. In this multicenter retrospective study, we aim to assess clinical prognosis and safety of this new LRH compared with traditional abdominal radical hysterectomy (ARH) in FIGO IB3 and IIA2 cervical cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 20 to 70 years
- •Preoperative clinical diagnosis was FIGO 2018 stage IB3 or IIA2 cervical cancer;
- •Patients who received standard Querleu-Morrow type C radical hysterectomy (including ARH or LRH based on space anatomy) and pelvic lymphadenectomy;
- •no preoperative suspected lymph nodes metastasis, parametrial involvement or lower 1/3 vagina involvement.
排除标准
- •patients who had active double cancer or uncontrolled serious concurrent disease that might compromise prognosis;
- •incomplete radical surgery;
- •follow-up time less than 6 months or lost to follow-up
结局指标
主要结局
Overall survival
时间窗: 5 years
The time from end of surgery to death from any cause.
Progression-free survival
时间窗: 5 years
The time from end of surgery to either the first documented disease progression or death from any cause.
次要结局
- Surgery complication rate(Intraoperative or within 2 weeks after surgery)
- Intraoperative blood loss(Intraoperative blood loss)
