Hernia-Prophylaxis in Acute Care Surgery H-PACS

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Incisional Hernia

Treatments: Procedure: Single running suture of abdominal fascia; Procedure: Strattice

Study type: Interventional

Funder types: Other

Identifiers

NCT03090022

2016-02212

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

61 participants in 2 patient groups

Mesh implantation

Active Comparator group

Description:

Prior to closure of the abdominal wall a mesh will be implanted in a standardized fashion

Treatment:

Procedure: Strattice

Single running suture of abdominal fascia

Active Comparator group

Description:

The closure of the abdominal wall a Standard technique will be applied using a running suture

Treatment:

Procedure: Single running suture of abdominal fascia