Biosynthetic Absorbable Mesh vs Standard of Repair for the Surgical Treatment of Infected Incisional Hernia
- Conditions
- Ventral Hernia Repair
- Interventions
- Procedure: Incisional hernia repair with simple suture or synthetic mesh reinforcement.Procedure: Incisional hernia repair with reinforcement of biosynthetic mesh
- Registration Number
- NCT04597840
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 108
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard of repair group Incisional hernia repair with simple suture or synthetic mesh reinforcement. Patient will undergo incisional hernia repair according to the standard of repair, which is simple suture or mesh reinforcement (using synthetic or biological meshes). biosynthetic mesh group Incisional hernia repair with reinforcement of biosynthetic mesh 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.
- Primary Outcome Measures
Name Time Method Rate of incisional hernia recurrence 3 years after surgery The rate of incisional hernia recurrence will be evaluated by radiologic imaging.
- Secondary Outcome Measures
Name Time Method Rate of screening failure 48 months after the start of the study The proportion of patients who did not receive the surgical procedure proposed by the study, and the related reasons of screening failure will be reported.
Incidence of re-operation related to incisional hernia repair For 3 years after surgery Incidence of incisional hernia repair-related complications leading to re-operation will be reported.
Days of hospitalization related to incisional hernia repair For 3 years after surgery Number of days of hospitalization related to hernia repair-related complications will be reported.
Incidence of wound events 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date Incidence of incisional hernia repair-related wound complications, such as wound infection will be reported.
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). The cost / quality ratio will be measured using the consumption of health care and the health status. In one hand, each health care action will be reported (by the patient or the caregiver) and then the total cost relative to the health care will be measured. In another hand, self-reported health status before and after incisional hernia repair will be done using the EQ-5D-5L questionnaire.
Incidence of revision surgery or interventional radiologic procedure 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date Incidence of revision surgery or interventional radiologic procedure related incisional hernia repair-related wound complications will be reported.
Rate of early incisional hernia recurrence 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date The rate of incisional hernia recurrence evaluated by physical examination and then confirmed by radiologic imaging will be reported.
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). Self reported clinical symptoms before and after incisional hernia repair will be done using a modified version of the Carolina Comfort Scale . Severity of pain and discomfort pre and post repair will be measured during different daily activities (item). Each item is scored 0-5 (0= no symptom ; 5= worst symptom).
Number of healing days 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date At each clinical examination, the time between surgery and the end of median scar care will be measured.
Trial Locations
- Locations (1)
Hôpital Lyon Sud
🇫🇷Pierre-Bénite, France