Hernia-Prophylaxis in Acute Care Surgery H-PACS (H-PACS)

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

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.

Study Overview

• Status: Completed
• Conditions: Incisional Hernia
• Intervention / Treatment: Procedure: Strattice; Procedure: Single running suture of abdominal fascia

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Berne, Switzerland, 3010
    • Dep. of Visceral and transplant surgery, Berne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Guido Beldi, Prof. Dr., Inselspital Berne

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): October 5, 2020
• Study Completion (ACTUAL): October 5, 2020

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (ACTUAL): March 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: 2016-02212

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No