Multicenter, Prospective, Longitudinal and Randomized Comparison of Both the Clinical and Economic Impact of Biosynthetic Absorbable Mesh to the Surgical Standard of Care in Contaminated Incisional Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Rate of incisional hernia recurrence
研究概览
简要总结
Incisional hernia is one of the most common complications of abdominal surgery and carries a significant burden for both patients and the economic health service. However, no consensus for the surgical treatment of incisional hernia in contaminated field is currently available. The purpose of the COMpACT-BIO study is to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair.
详细描述
The current standard of incisional hernia repair is reinforcement with permanent synthetic mesh. However, permanent synthetic mesh is contraindicated in contaminated surgical field due to higher risk of postoperative infection. In order to resist to infection, absorbable meshes, such as biological and biosynthetic meshes, have been developped. However, some controversies exist about the clinical benefit of biological meshes in the long term. Reasons for theses controversies are their overall risk of complication and recurrence and the lack of consensus in which surgical technique to apply. Moreover, the financial cost of biological meshes is very high. Recently developed, biosynthetic meshes appear to be a promising option ; Compared to biological meshes, they seem to have several advantages. However, such data demonstrating the beneficial use of biosynthetic mesh in contaminated incisional hernia repair is not available. In this regard, the COMpACT-BIO study aims to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair in comparison to the standard of repair. This is a multicenter, prospective, longitudinal and randomized study, which also offers a standardized technique of repair.
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
- Single (Outcomes Assessor)
盲法说明
The type of incisional hernia repair (simple suture or mesh reinforcement) will be masked to the primary outcome assessor.
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
- •All the following inclusion criteria must be fulfilled:
- •Age ≥18 years old
- •Physical status ASA < 4
- •Patient with a mid-line IH
- •Patient presenting with an IH without loss of domain
- •Surgical indication in elective surgery
- •"Potentially contaminated" grade III surgical environment according to the classification of the modified VHWG
- •Cure of mid line IH feasible according to the defined standard technical modality (placement of a retromuscular prosthesis)
- •No emergency surgical procedure
- •Status of social insured or entitled to a social insurance
- •Informed and signed consent of the patient after clear and appropriate information
排除标准
- •are as follows:
- •One or multiple incisional hernia out of the midline incision
- •Pregnancy, breastfeeding, parturient or childbearing patients without contraception
- •Known allergy to tetracyclines;
- •Persons protected by law
研究组 & 干预措施
biosynthetic mesh group
Patient will undergo incisional hernia repair with biosynthetic mesh reinforcement. Based on the discretion of the surgeon, two types of biosynthetic mesh from different brand can be used: the Phasix mesh from BARD or the BioA mesh from GORE. These two biosynthetic meshes are resorbable, which means they are gradually absorbed by the body.
干预措施: Incisional hernia repair with reinforcement of biosynthetic mesh (Procedure)
standard of repair group
Patient will undergo incisional hernia repair according to the standard of repair, which is simple suture or mesh reinforcement (using synthetic or biological meshes).
干预措施: Incisional hernia repair with simple suture or synthetic mesh reinforcement. (Procedure)
结局指标
主要结局
Rate of incisional hernia recurrence
时间窗: 3 years after surgery
The rate of incisional hernia recurrence will be evaluated by radiologic imaging.
次要结局
- Days of hospitalization related to incisional hernia repair(For 3 years after surgery)
- Rate of screening failure(48 months after the start of the study)
- Incidence of re-operation related to incisional hernia repair(For 3 years after surgery)
- Incidence of wound events(1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date)
- Assessment of health care consumption related to health care status(pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).)
- Incidence of revision surgery or interventional radiologic procedure(1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date)
- Rate of early incisional hernia recurrence(1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date)
- Incisional hernia specific quality-of-life assessment(Pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).)
- Number of healing days(1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date)