Laparoscopic Assisted Transanal Resection of Rectal Cancer With Total Mesorectal Excision
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- intraoperative complication
研究概览
简要总结
Rectal cancer is one of the frequent malignant neoplasms ,Total mesorectal excision (TME) has become the gold standard treatment for middle and lower rectal cancers. Laparoscopic TME still be difficult in patients with low rectal tumors, narrow pelvic anatomy, male sex or high body mass index . Difficult visualization of the pelvic anatomy along with the limitation of rigid laparoscopic instruments may affect the quality of oncological outcomes and increase the risks of injuries during surgery. A down to up approach via transanal total mesorectal excision (TaTME) technique may overcome these problems
详细描述
This clinical trial will be conducted at general surgery department of Assiut University Hospital .
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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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• rectal cancer histologically proven through biopsy
- •tumours located at least 3 cm from anorectal ring;
- •local spread restricted to the rectal wall
- •adequate preoperative sphincter function and continence;
- •absence of distant metastases.
- •Suitable for elective surgical resection
排除标准
- •• T4 tumours not responding to neoadjuvant chemo- radiotherapy
- •Patients under 18 years of age
- •Pregnancy
- •Previous rectal surgery (except local excision, endoscopic mucosal resection (EMR) or polypectomy)
- •Patients with acute intestinal obstruction
- •Multiple colorectal tumours
- •Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), Crohn's disease or ulcerative colitis
- •Planned synchronous abdominal organ resections
- •Preoperative evidence for distant metastases through imaging of the thorax and abdomen
- •Absolute contraindications to general anaesthesia,
- •presence of fecal incontinence,
- •undifferentiated tumors .
结局指标
主要结局
intraoperative complication
时间窗: 1 day
complication occured intraoperatively or on the first day of surgery
次要结局
- resection margin(1 years)
- morbidity rate(1 year)
- Mesorectal completeness(1 year)
- Mortality rate(1 years)
- Sexual functional outcomes(2 years)
- recurrance rate(2 years)
- Anorectal function outcomes(2 years)
研究者
mohamed abulfetouh
Principal investigator
Assiut University