Incisional Hernia
Conditions
Keywords
Incisional hernia, prevention, laparotomy closure, absorbable mesh
Brief summary
Background: Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation. This paper presents the rationale, design, and study protocol for a randomized controlled trial, the aim of which was to evaluate the efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for reinforcement of a midline fascial closure. Methods: The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh) is a multicenter randomized controlled trial in which adult patients undergoing elective or urgent open abdominal operations through a midline laparotomy incision are assigned to one of two groups based on the laparotomy closure procedure: an intervention group in which a continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore & Associates, Flagstaff, Arizona, USA), or a control group with continuous PDS suture only. Both groups are followed over 6 months. Outcomes: The primary outcome is the appearance of incisional hernias assessed by physical examination at clinical visits and radiologically (CT scan) performed at the end of follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma, burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate that suture plus prosthetic mesh insertion for routine midline laparotomy closure is effective in preventing incisional hernias after open abdominal surgery, to avoid the effects on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life, and to save costs potentially associated with incisional hernia surgical repair.
Interventions
PROCEDUREReinforcement with Absorbable Mesh
RADIATIONControl CT
At the end of the follow up (6 Months) a CT scan will be done. Radiologically the incisional hernia is defined as a solution of continuity of the linea alba seen on the abdominal CT scan with the patient at rest. The radiologist is blinded to the patient's history and the technique used for midline fascial closure.
OTHERClinical Follow Up
The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) Clinically, an incisional hernia is defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older, * Signed informed consent, * Patients undergoing elective or urgent open abdominal surgical procedures regardless of benign or malignant disease.
Exclusion criteria
* Presence of primary or recurrent incisional hernia * Expected survival \< 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of incisional hernia | 6 months | The primary endpoint is the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups. Because appearance of an incisional hernia occurs within the first months after laparotomy, assessment of efficacy was carried out during scheduled clinical visits over a period of 6 months. The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits and radiologically by an abdominal CT scan performed at the end of follow-up (6 months after operation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative complications | 30 days | Secondary endpoints are perioperative complications, including wound infection, hematoma, eventration, pain, reoperation. |
Countries
Spain
Contacts
Primary ContactManuel Lopez-Cano, MD, PhD
Outcome results
None listed