Evaluation of the Extraction-site Location in Laparoscopic Colorectal Surgery - Midline Incision vs Off-midline Incision-
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- cosmetic effect
研究概览
简要总结
The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision.
详细描述
Laparoscopic colon surgery is less invasive and more cosmetic than open surgery. But the extraction-site incision is 4 to 5 cm, and it is the largest and most painful incision in laparoscopic colon surgery. The purpose of this study is to evaluate the midline extraction incision in patients with colon cancer. A prospective randomized controlled trial is conducted to compare midline extraction incision with off-midline extraction incision. The investigators hypothesize that the use of the midline extraction incision in laparoscopic colon surgery will result in more cosmetic effect and better quality of life compared to the off-midline extraction incision.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor size is less than 5cm
- •No history of laparotomy
- •No bowel obstruction by tumor
排除标准
- •Patients who can't respond to medical question
- •Patients who receive steroids or insulin therapy
- •Uncontrolled DM
- •Severe respiratory failure(HOT)
结局指标
主要结局
cosmetic effect
时间窗: 1 year
Scar assessment score on the patient and observer scar assessment scale(POSAS)
次要结局
- Quality of life(7 days, 14 days and 30 days)
研究者
Hiroki Yamaue
Chief and professor of second department of surgery
Wakayama Medical University