Clinical trial NCT03090022: Hernia-Prophylaxis in Acute Care Surgery H-PACS
Official title: Prophylactic Mesh Implantation in Patients Undergoing Requiring Emergency Laparatomy for the Prevention of Incisional Hernia:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of incidence of death
timeFrame: up to 18 months
measure: Number of patients with hernia free survival
timeFrame: up to 18 months
Secondary outcomes:
measure: Number of patients with postoperative fascial dehiscence
timeFrame: 30 days
measure: Number of postoperative mortality
timeFrame: 90 days
measure: Number of surgical site infections postoperative
timeFrame: 30 days
measure: Number of postoperative intestinal fistulas
timeFrame: 30 days
measure: Number of small bowel obstructions
timeFrame: 18 months
measure: Number of patients with postoperative pain
timeFrame: 18 months
measure: Number of postoperative mesh infections
timeFrame: 18 months
measure: Number of postoperative mesh explantations
timeFrame: 18 months
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Dep. of Visceral and transplant surgery, Berne University Hospital
Study officials:
affiliation: Inselspital Berne
name: Guido Beldi, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: