NCT02468362Unknown2 期
Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer: a Double Blind Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 112
- 主要终点
- Disease Free survival
研究概览
简要总结
Through a double blinded study, patients with low rectal cancer will be randomized into two equal groups to compare between the 5 year disease free survival as a primary outcome measure.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low rectal cancer below 5 cm from the anal verge
- •Fit for laparoscopic total mesorectal excsion
- •T2, T3 rectal cancer
- •No distant metstasis
排除标准
- •T1, AND T4
- •Distant metastasis
- •Tumor infiltrating the dentate line
- •unwilling to participate
研究组 & 干预措施
Laparoscopic group
Active Comparator
干预措施: laparoscopic intersphincteric resection (Procedure)
Open group
Active Comparator
干预措施: open intersphincteric resection (Procedure)
结局指标
主要结局
Disease Free survival
时间窗: 5 years
次要结局
- Local recurrence(5 years)
- 5 year survival(5 years)
- Distant metstasis(5 years)
研究者
Osama Mohammad Ali ElDamshety
surgical oncology
Mansoura University
相似试验
已完成
不适用
Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in ChildrenGastroesophageal RefluxNCT00382850Johns Hopkins University68
终止
不适用
Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical HerniaIncisional HerniaUmbilical HerniaNCT00970515Assistance Publique - Hôpitaux de Paris98
Unknown
不适用
Comparison of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer:A Prospective Randomized TrialStomach NeoplasmLaparoscopyGastrectomyComplicationsNCT01043835Yan Shi328
已完成
不适用
Bilateral vs Unilateral Totally Extraperitoneal Repair Among Patients With Unilateral Inguinal HerniaInguinal HerniaNCT06380621B.P. Koirala Institute of Health Sciences60
已完成
不适用
Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric CancerEarly Gastric CancerNCT03136354Chinese University of Hong Kong36