Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Eventration rate
研究概览
简要总结
Randomized prospective experimental study, in which the effect of a prophylactic mesh is assessed in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy, considering as treatment the supra-aponeurotic mesh positioning (experimental group), and comparing it to the standard closing with a continuous suture using slow absorption monofilament.
详细描述
Randomized prospective experimental study, in which we evaluate patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy in order to:
Main objective:
- To assess the effect of the prophylactic mesh in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy.
Secondary objectives:
- To compare the appearance of complications in the control group and in the experimental group.
- Compare costs derived from short and long-term mesh placement in both groups.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double blind, for the patient and the radiologist who analyses the results of the imaging tests.
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
- •Elective surgery for colorectal cancer.
- •Surgery by middle laparotomy.
- •Informed consent signed by the patient.
- •Age > 18 years.
排除标准
- •Midline hernia or eventration.
- •Presence of mesh in the abdominal wall because of a previous surgery.
- •Palliative surgery.
- •Synchronous metastases (Stage IV cancer according to TNM).
研究组 & 干预措施
Supraaponeurotic mesh
Patients with laparotomy closure by conventional approach of aponeurosis (continuous suture with monofilament of slow absorption), and posterior placement of supraaponeurotic mesh of polyvinylidene fluoride (PVDF) medium / low density and wide pore. The mesh has a longitudinal measurement that exceeds about 3 cm the upper and lower ends of the wound and width should not be less than 10 cm, therefore the mesh selected is DynaMesh®-CICAT longitudinal measure 10x35 cm.
The mesh is fixed to the aponeurosis with a crown of loose stitches and points to the midline. A prolene 2/0 non-reabsorbable monofilament suture of cylindrical needle is used.
A 10 Fr suction drainage is placed in the supraaponeurotic plane, with an exit to the exterior beyond the edges of the prosthesis. Drainage will be preserved for a minimum of 48 hours after surgery, and will be withdrawn when a debit of less than 50 ml is presented in 24 h.
干预措施: DynaMesh®-CICAT longitudinal measure 10x35 cm (Device)
Monofilament
Patients with conventional closure of the middle laparotomy with approach of aponeurosis in a plane by continuous suture with monofilament of slow absorption. In this study, the suture used in all patients will be poly-4-hydroxybutyrate or Mono-max loop®.
结局指标
主要结局
Eventration rate
时间窗: 1 year
To assess the effect of the prophylactic mesh in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy.
次要结局
- Complications rate(1 year)
- Short and long term derived costs(1 year)