Overview

This trial is active, not recruiting.

Condition incisional hernias
Treatment abdominal surgery
Sponsor University Hospital Inselspital, Berne
Start date January 2011
End date March 2017
Trial size 150 participants
Trial identifier NCT01203553, KEK 094/10

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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
abdominal surgery
Intraoperative mesh implantation
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.
abdominal surgery
Intraoperative mesh implantation

Primary Outcomes

Measure
Incidence of incisional hernia
time frame: 3 years

Secondary Outcomes

Measure
Direct in-hospital costs
time frame: 3 years
Intraoperative complications
time frame: 3 years
Postoperative complications
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Mesh Implantation for Prophylaxis of Incisional Hernia
Principal investigator Guido Beldi, Prof. Dr. med.
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University Hospital Inselspital, Berne.