Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy (SHIELD Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Incidence of Incisional Hernia
研究概览
简要总结
The aim of this clinical trial is to evaluate whether placement of a synthetic prophylactic onlay mesh during definitive fascial closure can reduce the incidence of incisional hernia in adult patients managed with an open abdomen approach following emergency surgery.
The main questions it aims to answer are:
- Does prophylactic mesh placement reduce the incidence of incisional hernia compared with fascial closure without mesh?
- Does prophylactic mesh placement influence the occurrence of postoperative complications such as evisceration or surgical site infection?
Researchers will compare patients undergoing definitive fascial closure with prophylactic mesh placement to those undergoing fascial closure without mesh in order to determine whether the mesh decreases the incidence of incisional hernia and associated complications.
Participants will:
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Undergo standard open abdomen management followed by definitive fascial closure.
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Be randomly assigned to one of the two study groups:
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Definitive fascial closure without prophylactic mesh.
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Definitive fascial closure with placement of a synthetic prophylactic onlay mesh.
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Attend clinical follow-up visits in the general surgery outpatient clinic.
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Undergo clinical evaluations at 1, 6, and 12 months after surgery, including physical examination and, if necessary, imaging studies to detect incisional hernia or postoperative complications.
详细描述
This study will evaluate the impact of synthetic prophylactic onlay mesh placement during definitive fascial closure in patients managed with an open abdomen approach following emergency surgery.
This is a single-center randomized clinical trial with a 1:1 allocation to two treatment groups: definitive fascial closure with prophylactic mesh and definitive fascial closure without mesh. The study will include adult patients treated in the General Surgery Department of the Hospital Universitario Nuestra Señora de Candelaria who required open abdomen management and in whom definitive fascial closure can be achieved.
The primary outcome will be the incidence of incisional hernia during postoperative follow-up. Secondary outcomes will include the occurrence of evisceration and surgical site complications, including infection, seroma, hematoma, enteroatmospheric fistula, and the need for surgical reintervention.
Patients will undergo protocolized follow-up for at least 12 months after definitive fascial closure through outpatient general surgery visits, including physical examination and imaging studies when necessary.
The purpose of the study is to obtain preliminary evidence regarding the efficacy and safety of prophylactic mesh in this clinical setting, with the aim of optimizing open abdomen management and reducing the incidence of incisional hernia and other abdominal wall complications.
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
- None
盲法说明
No masking will be applied in this study. Both the surgeons and the investigators will be aware of the participants' group allocation due to the surgical nature of the procedure and the need to document the intraoperative management performed.
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
- •Patients older than 18 years.
- •Patients managed with an open abdomen approach.
- •Patients undergoing definitive fascial closure.
排除标准
- •Patients in whom definitive fascial closure cannot be achieved.
- •Inability to complete clinical follow-up or high likelihood of loss to follow-up (e.g., residence outside the catchment area, lack of outpatient follow-up, etc.)
研究组 & 干预措施
Definitive Fascial Closure Without Prophylactic Mesh
Patients will undergo definitive fascial closure following open abdomen management, without placement of prophylactic mesh. Perioperative management and clinical follow-up will be conducted according to the standard practice of the department.
干预措施: Definitive Fascial Closure Without Prophylactic Mesh (Procedure)
Definitive Fascial Closure With Prophylactic Onlay Mesh
Patients will undergo definitive fascial closure following open abdomen management, with placement of a synthetic, macroporous, non-absorbable prophylactic mesh (Optilene®, B. Braun Surgical S.A.) in the onlay position.
干预措施: Prophylactic Onlay Mesh Placement (Device)
结局指标
主要结局
Incidence of Incisional Hernia
时间窗: 12 months following definitive fascial closure.
o evaluate the occurrence of incisional hernia following definitive fascial closure in patients undergoing open abdomen management, comparing patients who receive prophylactic onlay mesh reinforcement with those who do not receive prophylactic mesh.
次要结局
- Burst abdomen rate(1 month after surgery)
- Surgical Site Occurrence(30 days after surgery)
研究者
Julen Ramon Rodríguez
Principal Investigator, General Surgery
University Hospital of the Nuestra Señora de Candelaria