Prophylactic Mesh Implantation for the Prevention of Incisional Hernia

NCT ID: NCT01203553

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2017-03-31

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

Conditions

Incisional Hernias

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Abdominal surgery

Intervention Type: PROCEDURE

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.

Abdominal surgery

Intervention Type: PROCEDURE

Intraoperative mesh implantation

Interventions

Abdominal surgery

Intraoperative mesh implantation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guido Beldi, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Berne, University Hospital, Univesrity of Berne, Switzerland

Locations

Dep. of Visceral and transplant surgery, Berne University Hospital

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 30476940 (View on PubMed)

Other Identifiers

KEK 094/10

Identifier Type: -

Identifier Source: org_study_id