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

Primary Purpose

Peritonitis, Incisional Hernia, Surgery

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
A non-absorbable composite mesh (Ethicon Physiomesh)
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peritonitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dep. of visceral and transplant surgery, Berne University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Conventional abdominal wall closure with mesh implantation

Conventional abdominal wall closure without mesh implantation

Outcomes

Primary Outcome Measures

Number of patients with incisional hernia

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2013
Last Updated
June 15, 2015
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT01802164
Brief Title
Prophylactic Mesh Implantation in Patients With Peritonitis for the Prevention of Incisional Hernia
Acronym
PerProMe
Official Title
Prophylactic Mesh Implantation in Patients With Peritonitis for the Prevention of Incisional Hernia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Recruitment problems due to very restricted inclusion criteria
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis, Incisional Hernia, Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Conventional abdominal wall closure with mesh implantation
Arm Title
2
Arm Type
No Intervention
Arm Description
Conventional abdominal wall closure without mesh implantation
Intervention Type
Device
Intervention Name(s)
A non-absorbable composite mesh (Ethicon Physiomesh)
Intervention Description
To compare prophylactic mesh implantation to conventional abdominal wall closure in patients undergoing emergency laparotomy for peritonitis.
Primary Outcome Measure Information:
Title
Number of patients with incisional hernia
Time Frame
54 months
Secondary Outcome Measure Information:
Title
Number of patients with facial dehiscence
Time Frame
54 months
Title
Mortality
Time Frame
54 months
Title
Number of patients with surgical site infection
Time Frame
54 months
Title
Number of patients with intestinal fistula
Time Frame
54 months
Title
Number of patients with small bowel obstruction
Time Frame
54 months
Title
Number of patients with postoperative pain
Time Frame
54 months
Title
Number of patients with low grade mesh infection or chronic subclinical inflammation
Time Frame
54 months
Title
Number of patients with mesh explantation
Time Frame
54 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Beldi, Prof. Dr. med.
Organizational Affiliation
Dep. of visceral and transplant surgery; Univesrity Hiospital, Berne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of visceral and transplant surgery, Berne University Hospital
City
Berne
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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

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