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

NCT01802164 | Terminated DMC

• 1 other identifier: 006/12
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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%.

Conditions

Peritonitis; Incisional Hernia; Surgery

Outcome Measures

Primary Outcomes (1)

• Number of patients with incisional hernia

  54 months

Secondary Outcomes (8)

• 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

Study Arms (2)

1

EXPERIMENTAL

Conventional abdominal wall closure with mesh implantation

Device: A non-absorbable composite mesh (Ethicon Physiomesh)

2

NO INTERVENTION

Conventional abdominal wall closure without mesh implantation

Interventions

A non-absorbable composite mesh (Ethicon Physiomesh) DEVICE

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with clinical signs of peritonitis
• Emergency laparotomy or laparoscopy with conversion to laparotomy
• Patients \> 18 years
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of visceral and transplant surgery, Berne University Hospital

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Peritonitis; Incisional Hernia

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Guido Beldi, Prof. Dr. med.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: March 1, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

CH (1)