NCT04643197Unknown不适用
Effects of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Disease (BARBHER)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 174
- 主要终点
- Cumulative incidence of incisional hernia
研究概览
简要总结
Investigators will compare the incidence of incisional hernia in women who underwent midline laparotomy whose abdominal fascia was closed with barbed suture vs. conventional non-barbed suture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Anticipating midline laparotomy for gynecologic diseases
- •ECOG performance status 0 - 2
排除标准
- •Previous or current abdominal incisional hernia
- •Previous radiation on abdomen area
- •Allergy to PDS or irgacare MP
- •Having disease affecting wound healing such as uncontrolled DM, autoimmune vasculitis, liver cirrhosis, coagulopathy
- •BMI > 35
- •Current or anticipated use of drugs affecting wound healing such as bevacizumab (with 4 week drug free period, bevacizumab user is eligible)
- •Abdominal midline laparotomy within 6 months
- •Surgery for infection control
结局指标
主要结局
Cumulative incidence of incisional hernia
时间窗: from surgery to 1 year
Incisional hernia till 1 year after surgery
次要结局
- Incidence of wound dehiscence(post-surgery 4weeks)
- Time-event curve of incisional hernia(from surgery to 1 year)
- Cumulative incidence of surgical site infection(from surgery to 4weeks)
- Brief Pain Inventory - Korean (BPI-K) score(Baseline, postoperative day 2, 4)
- Treatment related adverse event(from surgery to 1 year)
- NRS(from surgery to postoperative 4 day)
研究者
Kidong Kim
Professor
Seoul National University Bundang Hospital
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