Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair

NCT ID: NCT01189708

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-04-30

Brief Summary

The aim of this study is to investigate the effect of the implantation of an Ultrapro® Mesh as prevention of incisional hernia after elective open abdominal aortic aneurysm repair. According to the literature these patients have an increased risk for an incisional hernia. By the implantation of an artificial mesh into the abdominal wall during the first abdominal aortic aneurysm repair, the risk can be reduced dramatically. In small feasibility studies incisional hernia rates as low as 0% have been achieved.

Patients scheduled for elective open abdominal aortic aneurysm repair will be randomized into two groups, one receiving an onlay mesh, the other conventional wound closure with sutures.

Detailed Description

Prospective randomized controlled study with two study arms.

Arm 1: Abdominal wall will be closed with a prophylactic mesh implantation in onlay technique after elective open abdominal aortic aneurysm repair.

Arm 2: Abdominal wall will be closed with standard sutures (without mesh implantation)

After the patients gave their informed consent to participate in the study, they will be randomized to one of the two treatment arms. Allocation is carried out based on a prepared randomization list.

Primary endpoint is the rate of incisional hernias within the follow-up period of 2 years. Secondary endpoints are postoperative complications and adverse events during the follow-up period.

Study enrollment was prematurely terminated on 30. Apr 2009. Already enrolled patients will be followed for 24 months according to protocol.

Conditions

Abdominal Aortic Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mesh implantation

Ultrapro® Mesh implantation

Group Type: EXPERIMENTAL

Ultrapro® Mesh implantation

Intervention Type: DEVICE

After the aortic procedure (aortic aneurysm repair) an Ultrapro absorbable mesh will be used for the wound closure of the abdominal wall using an onlay technique.

Standard wound closure without a mesh

Standard wound closure

Group Type: ACTIVE_COMPARATOR

Standard wound closure

Intervention Type: OTHER

Abdominal closure will be performed with standard sutures without a mesh.

Interventions

Ultrapro® Mesh implantation

After the aortic procedure (aortic aneurysm repair) an Ultrapro absorbable mesh will be used for the wound closure of the abdominal wall using an onlay technique.

Intervention Type: DEVICE

Standard wound closure

Abdominal closure will be performed with standard sutures without a mesh.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient scheduled for elective or early elective open repair of aortic aneurysm

Exclusion Criteria

• Emergency surgery
• EVAR (endovascular procedure)
• Patients with previous midline laparotomy
• Patients with in situ abdominal mesh after previous hernia repair
• Patients with large diastasis of abdominal wall
• Allergy to penicillin
• Women before menopause (mesh can interfere with potential future pregnancies)

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

Sponsors

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: lead

Responsible Party

Ignazio Tarantino

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wolfgang Nagel, MD

Role: PRINCIPAL_INVESTIGATOR

KSSG

Locations

Kantonsspital St. Gallen, Department of Surgery

Sankt Gallen, Canton of St. Gallen, Switzerland

Countries

Switzerland

Other Identifiers

EKSG08/006

Identifier Type: -

Identifier Source: org_study_id