Hernia-Prophylaxis in Acute Care Surgery H-PACS

Incisional Hernia Clinical Trial

— H-PACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090022
• Other study ID #: 2016-02212
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: October 5, 2020

Study information

• Verified date: October 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 5, 2020
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Procedure:
• Strattice
Intra-abdominally Fixation
• Single running suture of abdominal fascia
Intra-abdominal suture

Locations

Country	Name	City	State
Switzerland	Dep. of Visceral and transplant surgery, Berne University Hospital	Berne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of incidence of death	follow-up	up to 18 months
Primary	Number of patients with hernia free survival	follow-up	up to 18 months
Secondary	Number of patients with postoperative fascial dehiscence	follow-up	30 days
Secondary	Number of postoperative mortality	survival	90 days
Secondary	Number of surgical site infections postoperative	follow-up	30 days
Secondary	Number of postoperative intestinal fistulas	follow-up	30 days
Secondary	Number of small bowel obstructions	follow-up	18 months
Secondary	Number of patients with postoperative pain	follow-up	18 months
Secondary	Number of postoperative mesh infections	follow-up	18 months
Secondary	Number of postoperative mesh explantations	follow-up	18 months