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

NCT01189708 | Terminated

• 1 other identifier: EKSG08/006
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal aortic aneurysm; Abdominal hernia

Outcome Measures

Primary Outcomes (1)

• Incidence of incisional hernia

  24 months

Secondary Outcomes (3)

• Rate of postoperative complications

  7 days

• operation time

  4 hours

• Rate of adverse events

  24 months

Study Arms (2)

Mesh implantation

EXPERIMENTAL

Ultrapro® Mesh implantation

Device: Ultrapro® Mesh implantation

Standard wound closure without a mesh

ACTIVE COMPARATOR

Standard wound closure

Other: Standard wound closure

Interventions

Ultrapro® Mesh implantation 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.

Mesh implantation

Standard wound closure OTHER

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

Standard wound closure without a mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

Study Sites (1)

Kantonsspital St. Gallen, Department of Surgery

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Hernia, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Wolfgang Nagel, MD

  KSSG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: August 27, 2010
• Study Start: March 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2011
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

CH (1)