Prophylactic Mesh Implantation in Patients With Peritonitis for the Prevention of Incisional Hernia (PerProMe)

Prophylactic Mesh Implantation in Patients With Peritonitis for the Prevention of Incisional Hernia: A Randomized Controlled Trial

In patients undergoing laparotomy, the incidence of abdominal wall related complications such as incisional hernia is very high. In particular in patients with peritonitis undergoing laparotomy the incidence of incisional hernia is up to 54.3%. Furthermore, these patients are at great risk for development of postoperative fascial dehiscence.

The gold standard of abdominal wall closure is a running slowly absorbable suture irrespective of the presence of peritonitis. Implantation of an intraperitoneal mesh potentially reduces the incidence of incisional hernia.

In a series of high risk patients in which we implanted non-absorbable intraperitoneal mesh prophylactically we reduced the incidence of incisional hernia down to 3.2%.

Study Overview

• Status: Terminated
• Conditions: Surgery; Peritonitis; Incisional Hernia
• Intervention / Treatment: Device: A non-absorbable composite mesh (Ethicon Physiomesh)

Detailed Description

Background

Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population [1,2]. An incisional hernia is defined as any abdominal wall gap with or without a bulge in the area of postoperative scar perceptible or palpable by clinical examination or imaging [3]. Overall incidence of incisional hernia at our institution with a follow-up of five years was 14%, whereas in patients undergoing liver transplantation we found an incidence of incisional hernia of 25% in a prospective study [2]. However, patients with peritonitis are at very high risk for the development of incisional hernia. Moussavian et al demonstrated an incidence of incisional hernia of 54.3% after a median follow-up of 6 years in patients undergoing emergency surgery for secondary peritonitis [4]. In patients undergoing surgical therapy for secondary peritonitis, redo surgery because of complications associated with the abdominal wall, such as fascial dehiscence and surgical site infection are frequent. Impaired wound healing in response to the systemic inflammatory response and the high incidence of surgical site infection might render the abdominal wall even more susceptible for incisional hernia, compared with the general surgical population [5,6]. Furthermore, patients with peritonitis undergoing emergency laparotomy develop fascial dehiscence in up to 24.1% [7]. Fascial dehiscence requires reoperation and is associated with a mortality rate up to 44% [8].

Objective

To compare prophylactic mesh implantation to conventional abdominal wall closure in patients undergoing emergency laparotomy for peritonitis.

Methods

Implantation of a non-resorbable intraperitoneal mesh in patients with peritonitis undergoing emergency laparotomy.

• Study Type: Interventional
• Enrollment (Actual): 5
• 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 with clinical signs of peritonitis
• Emergency laparotomy or laparoscopy with conversion to laparotomy
• Patients > 18 years
• Written informed consent

Exclusion Criteria

• Previous implanted mesh
• Incisional hernia present
• Small bowel obstruction without bowel resection
• Surgery for cholecystitis
• Inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
• Polytrauma patients
• Pregnant women
• Women younger than 45 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Conventional abdominal wall closure with mesh implantation	Device: A non-absorbable composite mesh (Ethicon Physiomesh); To compare prophylactic mesh implantation to conventional abdominal wall closure in patients undergoing emergency laparotomy for peritonitis.
NO_INTERVENTION: 2; Conventional abdominal wall closure without mesh implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with incisional hernia	54 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with facial dehiscence	54 months
Mortality	54 months
Number of patients with surgical site infection	54 months
Number of patients with intestinal fistula	54 months
Number of patients with small bowel obstruction	54 months
Number of patients with postoperative pain	54 months
Number of patients with low grade mesh infection or chronic subclinical inflammation	54 months
Number of patients with mesh explantation	54 months

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Guido Beldi, Prof. Dr. med., Dep. of visceral and transplant surgery; Univesrity Hiospital, Berne

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: February 15, 2013
• First Submitted That Met QC Criteria: February 27, 2013
• First Posted (ESTIMATE): March 1, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 16, 2015
• Last Update Submitted That Met QC Criteria: June 15, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Peritoneal Diseases; Postoperative Complications; Pathological Conditions, Anatomical; Intraabdominal Infections; Hernia; Peritonitis; Incisional Hernia
• Other Study ID Numbers: 006/12