Prophylactic Mesh Implantation for the Prevention of Incisional Hernia (ProphMesh)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01203553
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment
Incisional Hernias Procedure: Abdominal surgery

Detailed Description:


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.


  • 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


Prospective,two armed, controlled, randomized study

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mesh Implantation for Prophylaxis of Incisional Hernia
Study Start Date : January 2011
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Group/Cohort Intervention/treatment
Control Group
The main operation will be performed as planned. For the closure of the abdominal wall, a standard technique will be applied using a running suture of PDS 1 loop. The distance of the sutures to the fascial border is 1cm and the distance between two stitches is not more than 1cm. The total length of suture is at least 4 times the total length of the abdominal incision
Procedure: Abdominal surgery
Intraoperative mesh implantation
Treatment Group
The main operation will be performed as planned. Prior to the closure of the abdominal wall a mesh will be implanted in a standardized fashion: A Dynamesh IPOM mesh will be used for the present study. The mesh has a width of 15cm and is tailored to overlap lateral and cranial boarders at least 5cm. The mesh will be placed intra-abdominally and fixed using intra-abdominal stitches using Prolene 2/0 in all four corners. After the initial fixation of the mesh in all quadrants, the boarders of the mesh will be adapted using Prolene 2/0 running sutures. The fixation aims to prevent any intestinal structures to herniate onto the mesh. Afterwards, the abdominal wall is closed as described in the control group.
Procedure: Abdominal surgery
Intraoperative mesh implantation

Primary Outcome Measures :
  1. Incidence of incisional hernia [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Direct in-hospital costs [ Time Frame: 3 years ]
  2. Intraoperative complications [ Time Frame: 3 years ]
  3. Postoperative complications [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Population with a high risk for incisional hernia formation

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01203553

Dep. of Visceral and transplant surgery, Berne University Hospital
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Principal Investigator: Guido Beldi, Prof. Dr. med. Berne, University Hospital, Univesrity of Berne, Switzerland

Responsible Party: University Hospital Inselspital, Berne Identifier: NCT01203553     History of Changes
Other Study ID Numbers: KEK 094/10
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Keywords provided by University Hospital Inselspital, Berne:
Incisional hernias
Preperitoneal mesh

Additional relevant MeSH terms:
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes