Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Major postoperative complications
研究概览
简要总结
The purpose of this study is to assess different hybrid natural orifice transluminal endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of the technique, short term oncologic outcome and functional outcome.
详细描述
Intervention will be done by conventional laparoscopy and transanal endoscopy (TEO or Gelpoint platform), patients are divided into two arms to compare different natural orifice techniques in resection of colorectal cancer.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically fit patient.
- •Non metastatic pathologically proven sigmoid colon cancer.
- •Non metastatic pathologically proven rectal cancer.
- •Patient continent for stool.
排除标准
- •Patients with American Society of Anesthesiologist (ASA) score 4 and
- •Patients with cardiac or chest problems that cannot withstand insufflation.
- •Unresectable tumors (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation).
- •Obstructed or perforated cancer.
- •Patients with metastatic colorectal cancer.
- •Incontinent patients.
结局指标
主要结局
Major postoperative complications
时间窗: two weeks
leak-bleeding
Feasibility
时间窗: 24 hour
Rate of conversion to classic laparoscopy or to open laparotomy.
Operative blood loss
时间窗: 24 hour
measured in milliliter
Wound complications
时间窗: two week
infection-dehiscence
operative time
时间窗: 24 hour
time taken from starting operation till patient wake up
Major intraoperative complications
时间窗: 24 hour
bleeding -organ injury
次要结局
- Grading of quality and completeness of mesorectal excision(one month)
- Functional outcome(3 months)
- Adequacy of lymphadenectomy(one month)
- Longitudinal safety margin(one month)
- short term oncologic outcome(6 months - one year)
研究者
Islam Hany Metwally
Assistant lecturer of surgical oncology
Mansoura University