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Prophylactic Mesh Implantation for the Prevention of Incisional Hernia

Mesh Implantation for Prophylaxis of Incisional Hernia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01203553
Acronym
ProphMesh
Enrollment
150
Registered
2010-09-16
Start date
2011-01-31
Completion date
2017-03-31
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernias

Keywords

Incisional hernias, Prophylaxis, Preperitoneal mesh

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

Interventions

PROCEDUREAbdominal surgery

Intraoperative mesh implantation

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of incisional hernia3 years

Secondary

MeasureTime frame
Direct in-hospital costs3 years
Intraoperative complications3 years
Postoperative complications3 years

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026