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

NCT ID: NCT01802164

Last Updated: 2015-06-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-04-30

Brief Summary

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%.

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.

Conditions

Peritonitis; Incisional Hernia; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Conventional abdominal wall closure with mesh implantation

Group Type: EXPERIMENTAL

A non-absorbable composite mesh (Ethicon Physiomesh)

Intervention Type: DEVICE

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

2

Conventional abdominal wall closure without mesh implantation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

A non-absorbable composite mesh (Ethicon Physiomesh)

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guido Beldi, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Dep. of visceral and transplant surgery; Univesrity Hiospital, Berne

Locations

Dep. of visceral and transplant surgery, Berne University Hospital

Bern, Canton of Bern, Switzerland

Countries

Switzerland

Other Identifiers

006/12

Identifier Type: -

Identifier Source: org_study_id