Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- The rate of postoperative complications
研究概览
简要总结
The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients.
详细描述
This study is a prospective single-arm clinical study. 37 patients with right colon cancer undergoing laparoscopic right hemicolectomy with transrectal specimen extraction are planned to be included in the study. The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The primary endpoint is the postoperative complications of this type of natural orifice specimen extraction surgery (NOSES). The primary hypothesis is that NOSES could reduce postoperative complications. In addition, operating time, intraoperative bleeding, post-operative recovery and quality of life (QoL) are secondary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Biopsy proven colon carcinoma;
- •Imaging diagnosis of T1-3 colon cancer;
- •The tumor located in the cecum, ascending colon, or colonic hepatic flexure;
- •Maximal tumor diameter ≤5 cm;
- •Body mass index (BMI) ≤30 kg/m2;
- •Written informed consent;
排除标准
- •Complete intestinal obstruction;
- •Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
- •Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation;
- •Pregnancy or breastfeeding;
- •Alcohol abuse or drug addiction;
- •Concurrent uncontrolled medical condition;
结局指标
主要结局
The rate of postoperative complications
时间窗: up to 30 days
The rate of postoperative complications = patients with any postoperative complications/all cases.
次要结局
- Operating time(up to 1 days)
- Estimated blood loss(up to 1 days)
- The time of first flatus(up to 5 days)
- Postoperative hospitalization(up to 30 days)
研究者
Haitao Zhou
Clinical Professor
National Cancer Center, China