A Randomized Trial of Duramesh Versus PDS Loop Suture for Midline Incision Fascial Abdominal Closure Evaluation in Patients With Gynecological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Incidence of incisional hernia
研究概览
简要总结
FACE (Fascial Abdominal Closure Evaluation) Trial is a prospective, single center, open-label, randomized trial of Duramesh versus PDS loop suture for midline incision fascial abdominal closure evaluation in patients with gynecological malignancies
详细描述
Incisional hernias after midline incisions are estimated are estimated around 10-20%, which many times results in further surgical procedures. Many techniques with different sutures have been proposed of the years for fascial closure. PDS suture offers longer dissolution time, lower short-term tensile strength and lower knot security, however the highest quality data available for gynecological malignancies are from 30 years ago. On the other hand, the use of mesh suture (Duramesh) has been proposed as an alternative, in order to reduce postoperative hernias and abdominal wall complication rates. A recent systematic review on Duramesh shows promising results with a median incisional hernia occurrence of 3.4%, but the authors highlight the need for high-quality randomized controlled trials with long-term follow-up to evaluate the clinical benefits of Duramesh.
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 85 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Midline laparotomies for gynecological malignancies
- •Age 18 - 85 years old
- •ECOG Performance status: 0 - 2
排除标准
- •Pregnancy
- •Albumin < 3.5 g/dL
- •Previous history of any type of hernia
- •Previous midline incision (via laparotomy)
结局指标
主要结局
Incidence of incisional hernia
时间窗: Up to 12 months after randomization
Clinical or radiological detected
次要结局
- Incidence of wound dehiscence(Up to 1 month after randomization)
- Incidence of wound infection(Up to 1 months after randomization)
- Visual Analogue Scale (VAS) for wound pain(Fifth postoperative day after randomization)
研究者
Dimitrios Zouzoulas
Gynecological Oncologist, MSc, PhD, FEBS-BS, FESGO-EBCOG
Aristotle University Of Thessaloniki
