Prospective Randomized Study of Single Incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Rectal Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- morbidity
研究概览
简要总结
Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. The aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery.
Design: randomized, prospective clinical study Patients: 40 patients
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years of age.
- •ASA I-III.
- •Tumor-location: maximum 15 cm from the anal verge.
- •No involvement of neighbouring organs.
- •No distant metastasis.
排除标准
- •Linguistic, physical or psychological barriers precluding oral and written consent.
- •History of intestinal surgery (excl. appendectomy).
研究组 & 干预措施
SILS-group
20 patients undergoing Single Incision Laparoscopic Surgery
干预措施: Single Incision Laparoscopic Surgery (Procedure)
CLS-group
20 patients undergoing Conventional Laparoscopic Surgery for rectal cancer
结局指标
主要结局
morbidity
时间窗: 30 days
The purpose of this study is to compare 30-days postoperative morbidity between the two groups
次要结局
- immunology(72 hours postoperatively)
- postoperative outcome(5 days postoperatively)
- oncology(30 days)
研究者
Katrine Kanstrup Aslak
MD
Hvidovre University Hospital