Hernia-Prophylaxis in Acute Care Surgery H-PACS

Study Overview
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Brief Summary
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Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population. Patients requiring emergency laparotomy are at high risk for the development of incisional hernia and fascial dehiscence. Among this population the incidence of incisional hernia in patients undergoing emergency surgery varies between 33-54%. Incisional hernias are associated with a high morbidity rate, such as intestinal incarceration, chronic discomfort, pain, and reoperation and typically require implantation of a synthetic mesh in a later second operation. Fascial dehiscence represents an acute form of dehiscence and has been observed in up to 24.1% and is associated with a mortality rate up to 44%. The gold standard for abdominal wall closure during elective and emergency operations is a running slowly absorbable suture. In the elective situation it has been shown that prophylactic mesh implantation in high risk patients reduced the incidence of incisional hernia significantly. The investigators and others have shown that mesh implantation in patients undergoing emergency laparotomy or in contaminated abdominal cavities are safe . With a randomized controlled trial the investigators now aim to compare the incidence of incisional hernia after prophylactic mesh implantation versus standard of care in patients requiring emergency laparotomy.

Official Title
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Prophylactic Mesh Implantation in Patients Undergoing Requiring Emergency Laparatomy for the Prevention of Incisional Hernia:A Randomized Controlled Trial

Conditions
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Incisional Hernia

Intervention / Treatment
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* Procedure: Strattice
* Procedure: Single running suture of abdominal fascia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing emergency midline laparatomy Emergency laparoscopy with expected conversion to midline laparatomy Written informed consent Exclusion Criteria: ASA ≥5 Septic shock Pregnant women Prior mesh Implantation Known sensitivity for porcine material or Polysorbate 20

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesh implantation<br>Prior to closure of the abdominal wall a mesh will be implanted in a standardized fashion | Procedure: Strattice<br>* Intra-abdominally Fixation<br>* Other names: Acellular porcine dermal mesh;|
| Active Comparator: Single running suture of abdominal fascia<br>The closure of the abdominal wall a Standard technique will be applied using a running suture | Procedure: Single running suture of abdominal fascia<br>* Intra-abdominal suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of incidence of death | follow-up | up to 18 months | 
| Number of patients with hernia free survival | follow-up | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with postoperative fascial dehiscence | follow-up | 30 days | 
| Number of postoperative mortality | survival | 90 days | 
| Number of surgical site infections postoperative | follow-up | 30 days | 
| Number of postoperative intestinal fistulas | follow-up | 30 days | 
| Number of small bowel obstructions | follow-up | 18 months | 
| Number of patients with postoperative pain | follow-up | 18 months | 
| Number of postoperative mesh infections | follow-up | 18 months | 
| Number of postoperative mesh explantations | follow-up | 18 months |