The Mesh-RTL Project for Prevention of Incisional Hernia: Clinical Trial of Non-inferiority to Compare Two Aponeurotic Closure Techniques in Midline Laparotomy in Patients With Elevated Risk for Hernia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Number of participants with acute incisional hernia
研究概览
简要总结
Introduction:
By definition, the laparotomy is a surgical incision into the abdomen cavity performed to examine the abdominal and retroperitoneal organs. The evisceration/eventration and the hernia are considered the most frequent complication of the midline laparotomy with a high morbidity and mortality related. Conditions that will require a second intervention, in Mexico represent the seventh cause of elective surgery and fourth cause of emergency procedures. The objective of this study is to determine if the incidence of post-incisional hernia in patients with high risk after a midline laparotomy are similar between the closure of the abdominal wall with the RTL technique and the supraaponeurotic mesh closure reinforcement.
Material and Methods: Clinical trial comparing the use of mesh against the RTL technique for post-incisional hernia prophylaxis. Two groups, triple blind Analysis will be carried out with intent to treat and not inferiority with 95% confidence intervals
详细描述
Introduction:
By definition, the laparotomy is a surgical incision into the abdomen cavity performed to examine the abdominal and retroperitoneal organs.
It is classified according to the medical indication: exploratory, therapeutic, stagemaker, and recently added "damage-control" laparotomy.
There exists so many ways to access the abdominal cavity, usually in relation with the organ or structure to treat; being classified in midline laparotomy, paramedian, transversal, oblique, abdominal-thoracic, etc.
Either an emergency or scheduled procedure, the more usual and functional continues being the midline laparotomy, since it allows a broader and faster approach, with less bleeding and easily to extend if it becomes necessary.
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
- Double (Participant, Investigator)
盲法说明
The participant and investigator are masked
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 18 years undergoing midline laparotomy, independently of diagnostic or condition, elective or emergency surgery
- •Patients with a score equal or greater than 7 of the hernia score
- •Patients who accept to participate and sign the informed consent
排除标准
- •Patients managed with open abdomen or with the impossibility of close the wall
- •Patients who had a previous incisional hernia or patients who are participing in anohter trial
- •Patients with a life expectative less than 12 months
- •Pregnant patients Patients with the antecedent of rejection of prosthesic material
结局指标
主要结局
Number of participants with acute incisional hernia
时间窗: 30 days
An abdominal wall gap with or without bulge in the area of the postoperative scar palpable bi clinical examination (yes or not)
Number of participants with Incisional hernia
时间窗: 3 years
An abdominal wall gap with or without bulge in the area of the postoperative scar palpable bi clinical examination (yes or not)
次要结局
- Number of participants with seroma(10 days)
- Number of participants with surgical site infection(30 days)
- abdominal pain postoperative(5 days postoperative)
研究者
Edgard Lozada
Master in clinical research
Hospital Regional de Alta Especialidad del Bajio