Clinical trial NCT01203553: Prophylactic Mesh Implantation for the Prevention of Incisional Hernia
Official title: Mesh Implantation for Prophylaxis of Incisional Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernias
Keywords: Incisional hernias
Prophylaxis
Preperitoneal mesh
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population with a high risk for incisional hernia formation

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 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 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

Primary outcomes:
measure: Incidence of incisional hernia
timeFrame: 3 years
Secondary outcomes:
measure: Direct in-hospital costs
timeFrame: 3 years
measure: Intraoperative complications
timeFrame: 3 years
measure: Postoperative complications
timeFrame: 3 years
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Dep. of Visceral and transplant surgery, Berne University Hospital
Study officials:
affiliation: Berne, University Hospital, Univesrity of Berne, Switzerland
name: Guido Beldi, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kohler A, Lavanchy JL, Lenoir U, Kurmann A, Candinas D, Beldi G. Effectiveness of Prophylactic Intraperitoneal Mesh Implantation for Prevention of Incisional Hernia in Patients Undergoing Open Abdominal Surgery: A Randomized Clinical Trial. JAMA Surg. 2019 Feb 1;154(2):109-115. doi: 10.1001/jamasurg.2018.4221.