NCT05872334已完成不适用
Exploratory Clinical Trial for Evaluating the Safety and Efficacy of MONOFIX® on Fascial Closure of Mid-line Wound for Patients With Colon Cancer Underwent Minimally Invasive Surgery: Single-center, Non-blinded, and Single-arm Design
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incisional hernia
研究概览
简要总结
This clinical trial aims to evaluate the safety and feasibility of mid-line fascial suturing using MONOFIX sutures in patients undergoing minimally invasive surgery for colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Colorectal adenocarcinoma
- •Elective (or planned) curative surgery
- •Laparoscopic surgery
- •Midline incision less than 10 cm
排除标准
- •Previous laparotomy with midline incision more than 10cm.
- •Systemic chemotherapy for any cause within the last 6 months.
研究组 & 干预措施
Monofix
Experimental
In patients who underwent laparoscopic colorectal cancer surgery, the fascial closure of the midline incision was performed using a running suture type with Monofix, one of the barbed sutures.
干预措施: Monofix (Device)
Control group
No Intervention
In patients who underwent laparoscopic colorectal cancer surgery, the fascial closure of the midline incision was performed using an interrupted suture type with PDS-II, one of the monofilament sutures.
结局指标
主要结局
Incisional hernia
时间窗: 18 months from surgery
Incisional hernia diagnosed by CT scan.
次要结局
- Wound bleeding(1 month from surgery)
- Wound dehiscence(1 month from surgery)
- Wound infection(1 month from surgery)
研究者
Woo Yong Lee
Professor
Samsung Medical Center
研究点 (1)
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