Anastomotic Leakage in Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer : A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 250
- 主要终点
- anastomotic leakage rate
研究概览
简要总结
The study evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior resection.
详细描述
Laparoscopic surgeons commonly make rectal transection intracorporeally by laparoscopic linear stapler during rectal anterior resection and perform an end-to-end anastomosis by circular stapler. But the so-called 'dog ears', two stapled corners of the rectal stump after laparoscopic linear transection of rectum, are very common. The lateral intersections of double-stapled anastomoses are structural weak spot area, and they are considered to be the potential ischemic areas leading to anastomosis leakage and the possible sites occurring local recurrence. Previous study reported a modified technique for rectal reconstruction during open surgery, and they could use circular stapler to eliminate the staple line on the rectal stump and cut off the 'dog ears'. But because of the narrow pelvic cavity, it is very difficult to perform this technique in laparoscopic rectal surgery and there is no related report on laparoscopic application. In this study, we evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique, to eliminate the "dog ears" in laparoscopic rectal anterior resection by laparoscopic suturing on the staple line.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility rule of enrollment
- •Rectal adenocarcinoma above the peritoneal reflection
- •at least 18 years old & at most 80 years old
- •Clinically diagnosed cT1-T4aN0-2 disease
- •no contraindication to laparoscopic surgery
- •without other malignancies in medical history
排除标准
- •concurrent or previous diagnosis of invasive cancer within 5 years
- •locally advanced cancers requiring en bloc multivisceral resection
- •intestinal obstruction
- •intestinal perforation
- •American Society of Anesthesiologists(ASA) class 4 or 5
- •pregnant or breast-feeding women
- •history of mental disorder
- •participation in another rectal cancer clinical trial relating to surgical technique
结局指标
主要结局
anastomotic leakage rate
时间窗: 30 days since the date of surgery
次要结局
- QLQ 30(at postoperative 3,6 and 12 months)
- Intra-operative and post-operative complications(30 days since the date of surgery)
- re-operation rate(30 days since the date of surgery)
- post-operative Mortality(30 days since the date of surgery)
- Wexner's scoring(at postoperative 3,6 and 12 months)
研究者
Guoxian Guan
Professor
Fujian Medical University