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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University Hospital Inselspital, Berne
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01203553
First received: September 14, 2010
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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 Intervention
Incisional Hernias
Procedure: Abdominal surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Mesh Implantation for Prophylaxis of Incisional Hernia

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • incidence of incisional hernia [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • direct in-hospital costs [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • intraoperative complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • postoperative complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Population with a high risk for incisional hernia formation

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203553

Contacts
Contact: Guido Beldi, PD Dr. medm 0041 31 632 82 75 guido.beldi@insel.ch
Contact: Barbara Uhlmann, Study Nurse 0041 31 632 23 26 barbara.uhlmann@insel.ch

Locations
Switzerland
Dep. of Visceral and transplant surgery, Berne University Hospital Recruiting
Berne, Switzerland, 3010
Principal Investigator: Guido Beldi, PD Dr. med.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Guido Beldi, PD Dr. med. Berne, University Hospital, Univesrity of Berne, Switzerland
  More Information

No publications provided

Responsible Party: PD Dr. med. Guido Beldi, Insel University Hospital
ClinicalTrials.gov Identifier: NCT01203553     History of Changes
Other Study ID Numbers: KEK 094/10
Study First Received: September 14, 2010
Last Updated: August 26, 2013
Health Authority: Switzerland: Independent Local Research Ethic Commission (Ethikkommission)

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

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 20, 2014