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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
108
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.
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.
Hôpital Lyon Sud
Pierre-Bénite, France
RECRUITINGRate of incisional hernia recurrence
The rate of incisional hernia recurrence will be evaluated by radiologic imaging.
Time frame: 3 years after surgery
Days of hospitalization related to incisional hernia repair
Number of days of hospitalization related to hernia repair-related complications will be reported.
Time frame: For 3 years after surgery
Incidence of re-operation related to incisional hernia repair
Incidence of incisional hernia repair-related complications leading to re-operation will be reported.
Time frame: For 3 years after surgery
Incidence of wound events
Incidence of incisional hernia repair-related wound complications, such as wound infection will be reported.
Time frame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Incidence of revision surgery or interventional radiologic procedure
Incidence of revision surgery or interventional radiologic procedure related incisional hernia repair-related wound complications will be reported.
Time frame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Rate of early incisional hernia recurrence
The rate of incisional hernia recurrence evaluated by physical examination and then confirmed by radiologic imaging will be reported.
Time frame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Incisional hernia specific quality-of-life assessment
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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).
Time frame: Pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).
Number of healing days
At each clinical examination, the time between surgery and the end of median scar care will be measured.
Time frame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Rate of screening failure
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.
Time frame: 48 months after the start of the study
Assessment of health care consumption related to health care status
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.
Time frame: pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).