Transvaginal Natural Orifice Specimen Extraction Surgery Versus Conventional Laparoscopic Surgery With Mini-laparotomy in Right Hemicolectomy for Colon Cancer: a Randomised, Controlled, Phase 3, Non-inferiority Trial (NOSES VIIIA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- disease-free survival rate
研究概览
简要总结
It is controversial that totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction (NOSES VIIIA) can provide non-inferior oncological outcomes compared to conventional laparoscopic surgery with mini-laparotomy in the treatment of right colon cancer. We aim to carry out a multicenter, open-lable, parallel, non-inferiority, phase III, randomized controlled clinical trial, which enrolls 356 female patients with cT1-3NxM0 right colon adenocarcinoma. They are randomly assigned to the experimental group (NOSES VIIIA) or the control group (laparoscopic surgery with mini-laparotomy) in a 1:1 ratio. Perioperative indicators, pathological results, quality of life and cosmetic evaluation will be compared between the two groups. Then, a three-year follow-up of these patients will provide evidence for long-term oncological outcomes of NOSES VIIIA.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •volunteer to participate and the informed consent signed;
- •18-75 years;
- •female who have given birth;
- •pathologically confirmed adenocarcinoma/high-grade intraepithelial neoplasia by preoperative colonoscopy and biopsy;
- •preoperative CT or MRI indicates that the tumor diameter is no more than 5.0 cm;
- •preoperative staging cT1-3NanyM0
- •body mass index <30 kg/m2;
- •willing to undergo laparoscopic right hemicolectomy
排除标准
- •contraindications for laparoscopic surgery;
- •emergency surgery due to acute intestinal obstruction, perforation or bleeding;
- •distant metastasis;
- •multiple colorectal cancer;
- •has received preoperative chemoradiotherapy;
- •with a history of other malignant tumors;
- •unwilling to sign the informed consent or receive follow-up according to the study protocol.
结局指标
主要结局
disease-free survival rate
时间窗: 3 years after surgery
disease-free survival rate
次要结局
未报告次要终点
研究者
Cai Zhenghao
Dr.
Shanghai Minimally Invasive Surgery Center