NCT04037956招募中不适用
A Perspective Study to Compare the Tubeless NOSES and Traditional Laparoscopic Radical Resection in Rectosigmoid Cancers (CORNER)
Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 458 人开始时间: 2019年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
This study is designed to evaluate the short-term and long-term results after Tubeless NOSES for the resection of Rectosigmoid Cancers compared with traditional laparoscopic radical resection.
详细描述
This is a randomized, single-center, open-label, non- inferiority study designed to evaluate the safety, efficacy and potential benefits of Tubeless NOSES compared with traditional laparoscopic radical resection in approximately 458 subjects with Rectosigmoid Cancers.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed Rectosigmoid Cancers
- •Clinical stage at T 1-3 N0-2 M0
- •Tumors on peritoneal reflection，Tumor size is no more than 3 cm
- •Eastern Cooperative Oncology Group (ECOG) scale is 0-2
- •American Society of Anesthesiologists (ASA) score is Ⅰ-Ⅲ
- •BMI ≤ 30 kg/m2
- •Subjects must be willing and able to comply with scheduled visits, treatment schedule,and laboratory testing.
排除标准
- •Heart, lung, liver or renal or any organ function that are intolerance for surgery
- •History of treated colorectal malignant disease
- •Subjects with medical condition, such as intestinal obstruction, intestinal perforation, bleeding, requires emergency surgery
- •Subjects with previous malignancies
- •History of inflammatory bowl disease(IBD) or familial adenomatous polyposis (FAP)
- •Treatment with any other clinical trial within 28 days prior to randomization
- •History of severe mentally disease
- •pregnant or lactating women
- •The researchers believe that the patients are unsuitable to participate in the researchers with other cases.
研究组 & 干预措施
Tubeless NOSES
Experimental
Patients receive Tubeless NOSES.
干预措施: Tubeless NOSES (Procedure)
traditional laparoscopic
Active Comparator
Patients receive traditional laparoscopic radical resection.
干预措施: traditional laparoscopic radical resection (Procedure)
结局指标
主要结局
3-year disease free survival rate
时间窗: 36 months after surgery
次要结局
- Incidence of postoperative complications(1 month after surgery)
- the blood loss during the operation(in the perioperative period)
- the functional outcome of defecation(60 months after surgery)
- the operation time(in the perioperative period)
- Pain score(in the perioperative period)
- number of cases converted to laparotomy(in the perioperative period)
- 5-year overall survival rate(60 months after surgery)
- Postoperative recovery of intestinal peristalsis(in the perioperative period)
- the mean postoperative hospitalization day(in the perioperative period)
研究者
Yanxin Luo,MD
Deputy Chief Physician
Sixth Affiliated Hospital, Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Study of Alteration in Cuff Pressure Position, Ventilator Mode or Time.CTRI/2022/04/042130AIIMS RISHIKESH
招募中
不适用
Effect of neogard protection to reduce nasal injury in preterm infants receiving N-CPAPasal injury associated with N-CPAP in preterm infants.Preterm [premature] newborn [other]P07.3IRCT20191217045769N1Esfahan University of Medical Sciences80
已完成
不适用
Comparison of the effectiveness of nasal continuous positive airway pressure (NCPAP) therapy with combination of High-Frequency Oscillations and NCPAP in treatment of respiratory distress syndrome in infantsP22.0Respiratory distress syndrome.Respiratory distress syndrome of newbornIRCT20180915041040N3Shahre-kord University of Medical Sciences40
招募中
不适用
Comparisons of usefulness between nasogastric tube lavage and EG scan before emergency endoscopy in patients with upper GI bleedingDiseases of the digestive systemKCT0000261Yonsei University, Wonju Severance Christian Hospital100
已完成
2 期
Comparison of tubes passed through nose at room temperature with and soft tubes prewarmed for different duration of time to prevent nasal trauma and bleedingCTRI/2017/02/007840Anuja Agrawal45