Hernia-Prophylaxis in Acute Care Surgery H-PACS

Not Applicable

Completed

• Conditions: Incisional Hernia
• Interventions: Procedure: Strattice; Procedure: Single running suture of abdominal fascia

• Registration Number: NCT03090022
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-24
• Primary Completion: 2020-10-05
• Study Completion: 2020-10-05
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesh implantation	Strattice	Prior to closure of the abdominal wall a mesh will be implanted in a standardized fashion
Single running suture of abdominal fascia	Single running suture of abdominal fascia	The closure of the abdominal wall a Standard technique will be applied using a running suture

Primary Outcome Measures

Name	Time	Method
Number of incidence of death	up to 18 months	follow-up
Number of patients with hernia free survival	up to 18 months	follow-up

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dep. of Visceral and transplant surgery, Berne University Hospital; 🇨🇭 Berne, Switzerland