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

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01189708
• Other study ID #: EKSG08/006
• Status: Terminated
• Phase: N/A
• Start date: March 2008
• Est. completion date: April 2011

Study information

• Verified date: September 2023
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 2011
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Hernia
• Incisional Hernia

Intervention

Device:
• 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.

Other:
• Standard wound closure
Abdominal closure will be performed with standard sutures without a mesh.

Locations

Country	Name	City	State
Switzerland	Kantonsspital St. Gallen, Department of Surgery	St. Gallen	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of incisional hernia		24 months
Secondary	Rate of postoperative complications		7 days
Secondary	operation time		4 hours
Secondary	Rate of adverse events	Adverse events related to mesh implantation	24 months

External Links

•   Homepage of the Department of Surgery, Cantonal Hospital St. Gallen (KSSG)