Clinical Trial: Prophylactic Mesh Implantation for the Prevention of Incisional Hernia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Mesh Implantation for Prophylaxis of Incisional Hernia

Brief Summary:

Incisional hernias are primarily repaired using prosthetic meshes. In Switzerland such meshes are mainly implanted via open or laparoscopic approach. The differential impact of these two types of surgical technique on recurrence rate will be investigated with this study.

With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia repair will be investigated prospectively. Hernia recurrence is the main outcome measure.


Detailed Summary:

Background

Incisional hernia is one of the most common complication in general abdominal surgery. An overall incidence of 20% has been found in retrospective studies, ranging in up to 50% of patients with selected risk factors such as obesity.

In the general surgical patient the current standard is the closure of the abdominal wall using a running, slowly absorbable suture. With this well established clinical practice the incidence remains high and incisional hernia repair must be performed frequently in order to treat patients`symptoms and to prevent progression of the hernia an possible complications.

Consequently, in high risk patients prophylactic mesh implantation is performed routinely in our institution.

Objective

  • Occurrence of at least two of the following factors:

    • Male gender
    • Malignant tumor present
    • Body mass index above 25kg/m2
    • Previous laparotomy
  • Elective operation
  • Patient >18 years
  • Written informed consent

Methods

Prospective,two armed, controlled, randomized study


Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome: Incidence of incisional hernia [ Time Frame: 3 years ]

Original Primary Outcome: Incidence of incisional hernia [ Time Frame: 5 years ]

Current Secondary Outcome:

  • Direct in-hospital costs [ Time Frame: 3 years ]
  • Intraoperative complications [ Time Frame: 3 years ]
  • Postoperative complications [ Time Frame: 3 years ]


Original Secondary Outcome:

  • Direct in-hospital costs [ Time Frame: 5 years ]
  • Intraoperative complications [ Time Frame: 2 years ]
  • Postoperative complications [ Time Frame: 5 years ]


Information By: University Hospital Inselspital, Berne

Dates:
Date Received: September 14, 2010
Date Started: January 2011
Date Completion:
Last Updated: April 10, 2017
Last Verified: April 2017