Prospective Randomized Comparison of Single-port and Four-port Laparoscopic Staging Operation for Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- operating time
研究概览
简要总结
To compare the feasibility, safety, and efficacy between single-port and four-port laparoscopic surgical staging in patients with early stage endometrial cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Previously untreated, histologically confirmed endometrial cancer
- •Presumed FIGO stage 1
- •Endometrioid adenocarcinoma
- •patient who is planned to undergo surgical staging
- •adequate oran function
- •WBC > 3000 cells/mcl
- •Platelets > 100000/mcl
- •Creatinine < 2.0 mg/dL
- •Bilirubin < 1.5 * normal and SGOT or SGPT < 3 * normal
- •American Society of Anesthesiologists Physical Status I-II
- •Eastern Cooperative Oncology Group performance status 0-2
- •Patients who have signed an approved Informed Consent
排除标准
- •Uncontrolled medical disease
- •Active infectious disease requiring antibiotics
- •Previous pelvic radiation therapy
- •Pregnant and lactating woman
- •Patient who requires additional surgical procedures which are not necessary for surgical staging of endometrial cancer
研究组 & 干预措施
Single-port surgery group
Single-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
干预措施: single-port laparoscopic surgical staging (Procedure)
Four-port surgery group
Four-port laparoscopic surgical staging including total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
干预措施: Four-port laparoscopic surgical staging (Procedure)
结局指标
主要结局
operating time
时间窗: 1 day (Immediately after operation)
Total operation time and time required for each procedure are calculated and compared.
Number of lymph nodes retrieved
时间窗: 1 week after surgery
The number of right pelvic lymph nodes and left pelvic lymph nodes were obtained and compared.
次要结局
- transfusion requirement and amount(within 1 week after surgery)
- Postoperative pain(within 1 week after surgery)
- Postoperative analgesics requirement(within 1 week after surgery)
- postoperative complications(within 1 month after surgery)
- recurrence free survival(34 months after surgery)
- overall survival(34 months after surgery)
研究者
Joo-Hyun Nam
Professor
Asan Medical Center