跳至主要内容
临床试验/NCT06759480
NCT06759480尚未招募不适用

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

International Peace Maternity and Child Health Hospital0 个研究点目标入组 500 人开始时间: 2024年12月27日最近更新:
适应症

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

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)

研究者

发起方
International Peace Maternity and Child Health Hospital
申办方类型
Other
责任方
Sponsor

相似试验