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NCT Number: NCT01203553

Prophylactic Mesh Implantation for the Prevention of Incisional Hernia

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.

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Key information

Conditions

Incisional Hernias Hernia Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Visceral and transplant surgery, Berne University Hospital

Bern, 3010, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abdominal surgery

Procedure

Intraoperative mesh implantation

Primary outcomes

  1. Incidence of incisional hernia

    Time frame: 3 years

Secondary outcomes

  1. Direct in-hospital costs

    Time frame: 3 years

  2. Intraoperative complications

    Time frame: 3 years

  3. Postoperative complications

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Mesh Implantation for Prophylaxis of Incisional Hernia

Acronym: ProphMesh

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2010
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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