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

This study has suspended participant recruitment.
(Pending evaluation of regulatory authorities)
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01802164
First received: February 15, 2013
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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%.


Condition Intervention
Peritonitis
Incisional Hernia
Surgery
Device: A non-absorbable composite mesh (Ethicon Physiomesh)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prophylactic Mesh Implantation in Patients With Peritonitis for the Prevention of Incisional Hernia: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Number of patients with incisional hernia [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients with facial dehiscence [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]
  • Number of patients with surgical site infection [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]
  • Number of patients with intestinal fistula [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]
  • Number of patients with small bowel obstruction [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]
  • Number of patients with postoperative pain [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]
  • Number of patients with low grade mesh infection or chronic subclinical inflammation [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]
  • Number of patients with mesh explantation [ Time Frame: 54 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: March 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802164

Locations
Switzerland
Dep. of visceral and transplant surgery, Berne University Hospital
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Guido Beldi, Prof. Dr. med. Dep. of visceral and transplant surgery; Univesrity Hiospital, Berne
  More Information

No publications provided

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01802164     History of Changes
Other Study ID Numbers: 006/12
Study First Received: February 15, 2013
Last Updated: November 14, 2013
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Additional relevant MeSH terms:
Hernia
Peritonitis
Pathological Conditions, Anatomical
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014