NCT01810874已完成不适用
STELLA Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of lymph nodes
研究概览
简要总结
The purpose of this study is to determine whether the extraperitoneal approach is better than the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of endometrial cancer confirmed by histopathological analysis (endometrial biopsy) requiring surgical staging according to FIGO (the International Federation of Gynecology and Obstetrics) recommendations
- •Diagnosis of ovarian cancer confirmed by histopathological analysis after an initial cystectomy or oophorectomy without suspicion of neoplasia thus requiring additional surgical staging according to FIGO recommendations
排除标准
- •Diagnosis of advanced endometrial cancer based on findings on imaging techniques (CT, MRI and/or PET)
- •Diagnosis of advanced endometrial or ovarian cancer based on intraoperative findings (e.g. peritoneal carcinomatosis at initial laparoscopy)
- •Patients who underwent previous aortic lymphadenectomy
- •Patients who received previous pelvic and/or aortic radiotherapy
结局指标
主要结局
Number of lymph nodes
时间窗: After aortic lymphadenectomy is completed
The number of lymph nodes (absolute number) is specified by the pathologist on histopathological analysis of the sample sent by the surgeon after surgical staging is realized (laparoscopic aortic lymphadenectomy). This variable is subdivided into: supra-mesenteric and infra-mesenteric.
次要结局
- Operative time(At the time of the surgery)
- Early Postoperative complications(within 30 days after surgery)
- Intraoperative complications(At the time of surgery)
- Late Postoperative complications(past 30 days after surgery)
- Overall survival(up to 3 years)
- Disease-free survival(up to 3 years)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian CancerEndometrial NeoplasmsOvarian NeoplasmsNCT02676726Hospital Universitari Vall d'Hebron Research Institute208
Unknown
不适用
Catheter-directed Sclerotherapy Versus Surgical Resecction: Randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian EndometriomaOvarian EndometriomaNCT05279209Yonsei University98
已完成
不适用
Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia RepairInguinal HerniaNCT03276871The Cleveland Clinic40
已完成
不适用
ExPECT: Extraperitoneal End Colostomy TrialColostomy StomaCancer of ColonSurgeryQuality of LifeNCT05163873Swansea Bay University Health Board23
Unknown
3 期
Endolaparoscopic Versus Immediate Surgery for Obstructing Colorectal CancersBowel ObstructionColorectal CancerNCT00164879Chinese University of Hong Kong70