Prophylactic Mesh Implantation for the Prevention of Incisional Hernia

Incisional Hernias Clinical Trial

— ProphMesh  

Official title:

Mesh Implantation for Prophylaxis of Incisional Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203553
• Other study ID #: KEK 094/10
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: April 10, 2017
• Start date: January 2011
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Occurrence of at least two of the following factors:

• Male gender

• Malignant tumor present

• Body mass index above 25

• Previous laparatomy

• Elective operation

• Patient > 18 years

• Written informed consent

Exclusion Criteria

• Previous intra-abdominal mesh placement

• Emergency procedures

• Previous incisional hernia

• Inflammatory bowel disease

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Incisional Hernias

Intervention

Procedure:
• Abdominal surgery
Intraoperative mesh implantation

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	Incidence of incisional hernia		3 years
Secondary	Direct in-hospital costs		3 years
Secondary	Intraoperative complications		3 years
Secondary	Postoperative complications		3 years