Ventral Hernia Repair
Conditions
Keywords
ventral hernia repair, contaminated surgical field, infected incisional hernia, biosynthetic mesh
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.
Interventions
PROCEDUREIncisional hernia repair with reinforcement of biosynthetic mesh
The biosynthetic mesh (Phasix or Bio-A meshes) will be placed as a sublay in the retromuscular position to reinforce midline fascial closure. All the surgical procedure (including placement and fixation of the mesh) will be performed according to a standardized protocol.
PROCEDUREIncisional hernia repair with simple suture or synthetic mesh reinforcement.
Based on the discretion of the surgeon, the incisional hernia repair will be done by simple suture or by synthetic mesh reinforcement. All the surgical procedure (including placement and fixation of the mesh if applicable) will be performed according to a standardized protocol.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The type of incisional hernia repair (simple suture or mesh reinforcement) will be masked to the primary outcome assessor.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 The
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of incisional hernia recurrence | 3 years after surgery | The rate of incisional hernia recurrence will be evaluated by radiologic imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
Countries
France
Contacts
Primary ContactGuillaume PASSOT, Pr
Outcome results
None listed