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

Surgery Clinical Trial

— PerProMe  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01802164
• Other study ID #: 006/12
• Status: Terminated
• Phase: N/A
• First received: February 15, 2013
• Last updated: June 15, 2015
• Start date: March 2013
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Peritonitis
• Surgery

Intervention

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.

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 patients with incisional hernia		54 months	Yes
Secondary	Number of patients with facial dehiscence		54 months	Yes
Secondary	Mortality		54 months	Yes
Secondary	Number of patients with surgical site infection		54 months	Yes
Secondary	Number of patients with intestinal fistula		54 months	Yes
Secondary	Number of patients with small bowel obstruction		54 months	Yes
Secondary	Number of patients with postoperative pain		54 months	Yes
Secondary	Number of patients with low grade mesh infection or chronic subclinical inflammation		54 months	Yes
Secondary	Number of patients with mesh explantation		54 months	Yes