OMEGA Trial: A Multicenter Randomized Controlled Non-inferiority Trial of Only MEsh Fixation With a Glue Applicator Comparing Traumatic vs Atraumatic Fixation of the Mesh in Ventral/Incisional Laparoscopic Repair
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 主要终点
- Rate of the recurrence on ventral or incisional hernia repair 2 years postoperatively assessed by a clinical and/or imaging technique.
研究概览
简要总结
This multicenter randomized controlled non-inferiority trial of only mesh fixation with a glue applicator is a trial to evaluate the outcomes between atraumatic laparoscopic mesh fixation with GLUTACK-Glubran2® and conventional traumatic fixation, so the primary endpoint of the study is to analyze the recurrence on ventral or incisional hernia repair 2 years postoperatively assessed by a clinical and/or imaging technique.
详细描述
Patients older than 18 years undergoing an elective ventral/incisional hernia laparoscopic repair with a hernia defect between 4-10cm of transversal defect The patients included are adults with a BMI lesser than 35 Kg/m2 undergoing an elective laparoscopic primary ventral or incisional hernia repair with a fascial transverse defect between 4-8 cm (W2 EHS) on anterior or lateral location (M1-M5 up to 10 cm of length or L1-3) For the interventional procedure, three ports are used (1x11 mm and 2x5 mm) and after adhesiolysis and the field prepared, the defect is measured with a local standard in a craneo-caudal and transversal directions. Then, the defect is closed with a 2-0 caliber barbed suture following its biggest axis. A Dynamesh IPOM previously hydrated (2-3 min) is introduced throughout the 11mm trocar and extended. After this maneuver, mesh fixation is performed depending on the randomized arm (125 per arm): either traumatic fixation with the conventional procedure and device or with Glutack-Glubran®2.
After two years of follow-up, the recurrence will be analyzed.
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 (Care Provider, Investigator)
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
- •All adults with a BMI lesser than 35 Kg/m2 undergoing an elective laparoscopic primary ventral or incisional hernia repair with a fascial transverse defect between 4-8 cm (W2 EHS) on anterior or lateral location (M1-M5 up to 10 cm of length or L1-3)
- •ASA grade from I-II
- •Informed consent signed
排除标准
- •Patients less than 18 years and over 80 years of age.
- •Fascial transverse defect less than 4 cm and more than 8 cm.
- •Recurrent ventral or incisional hernia in the same place
- •Emergency surgery
- •Procedure involving concomitant surgeries (e.g. gastrointestinal, biliary or genitourinary surgery)
- •BMI greater than 35 Kg/m2
- •ASA III-IV
- •Pregnancy
研究组 & 干预措施
Conventional
Patients with a traumatic fixation of the mesh
干预措施: Conventional (Device)
Glutack
Patient with Glutack mesh fixation
干预措施: Glutack (Device)
结局指标
主要结局
Rate of the recurrence on ventral or incisional hernia repair 2 years postoperatively assessed by a clinical and/or imaging technique.
时间窗: 2 years
The fixation of the mesh with atraumatic material with glue is as good as the conventional traumatic fixation
次要结局
- Types of comorbidities related on the surgery as visceral adhesions, seroma, hematoma, bulging, port site incisional hernia, recurrence(2 years)
- Rate of postoperative pain between atraumatic and traumatic fixation of the mesh (EuraHS Quality of life scale: 0-10). Ten is the worst outcome(2 years)
- Quality of life (QoL) between the two types of fixations with the EuraHS scale at 1 month, 6 months, 12 months, and 24 months. EurasHS scale of 10 is the worst outcome(2 years)
研究者
Rafael Villalobos Mori
Head of Abdominal Wall Unit Surgery
Institut Catala de Salut