Prevention of Incisional Hernia With Mesh-suture (Duramesh Suture) at Umbilical Trocar Site in Patients Who Undergo Laparoscopic Surgical Approach
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Incidence of the umbilical trocar site hernia in each group
研究概览
简要总结
Incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures. However, this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs.
The incidence of incisional trocar site hernia ranges from 20 to 35% of patients after laparoscopic surgery depending on the different investigations. Prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients. In that sense, suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias.
INDURATE TRIAL aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Adults (at least 18 year-old patients)
- •Umbilical trocar incision > 10 mm
- •Any of the following risk factors: BMI > 27, Absence of primary umbilical hernia or smaller than 1 cm, active smoking, malnutrition, anemia, oncological surgery, diabetes, heart failure, chronic kidney disease, chronic liver disease, collagen disease, chronic pulmonary disease.
排除标准
- •Umbilical trocar incision < 10 mm
- •Umbilical hernia > 10 mm
- •Hernia surgery or incisional hernia at the trocar site
- •Conversion to laparotomy
- •Pregnancy
- •Ascites or cirrhosis
- •Clasification of the American Anestesiology Classification IV o V.
- •Inadequate follow-up
- •Patients included in any other trial
- •Patients with life expectancy < 12 months
- •Patients with any kind of sensibility to Duramesh
结局指标
主要结局
Incidence of the umbilical trocar site hernia in each group
时间窗: 12 monts
Evaluation of the incidence of umbilical trocar site hernia in duramesh group compared with the control group
次要结局
- Infectious complications of the wound(12 months)
- Early aponeurotic failure (evisceration)(12 months)
- Intraabdominal events(12 months)
- Seroma and hematoma(12 months)
- Skin dehiscence and/or necrosis(12 months)
研究者
Miguel A ngel Garci-a Urena
Professor Miguel Ángel García Ureña
Henares University Hospital