Abdominal Aortic AneurysmNCT01189708
Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair
A study testing Ultrapro® Mesh implantation and Standard wound closure in people with Abdominal Aortic Aneurysm, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Ultrapro® Mesh implantation and Standard wound closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for elective or early elective open repair of aortic aneurysm
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital St. Gallen, Department of Surgery
Sankt Gallen, Canton of St. Gallen, 9007
About this study
Official title: Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair
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.
Read the 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
- Being tested
- Ultrapro® Mesh implantation, Standard wound closure
- Keywords
- Abdominal aortic aneurysm, Abdominal hernia
- Medical subject headings
- Aortic Aneurysm, Abdominal, Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrapro® Mesh implantationDevice
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 closureOther
Abdominal closure will be performed with standard sutures without a mesh.
| Study group | Role | What they receive |
|---|---|---|
| Mesh implantation | Experimental | Ultrapro® Mesh implantation Receives: Device: Ultrapro® Mesh implantation |
| Standard wound closure without a mesh | Active comparator | Standard wound closure Receives: Other: Standard wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of incisional hernia
Measured: 24 months
Secondary outcomes (3)
Rate of postoperative complications
Measured: 7 days
operation time
Measured: 4 hours
Rate of adverse events
Adverse events related to mesh implantation
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startMar 2008
- Primary completionApr 2009
- Study completionApr 2011
Why it stopped: Treatment without success, low enrollment, one serious adverse event
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignazio Tarantino, Cantonal Hospital of St. Gallen
- Investigators
- Wolfgang Nagel, MD, Principal investigator, KSSG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189708
- Sponsor's protocol ID
- EKSG08/006
- Status last verified
- Sep 2023
- First submitted
- 20 Feb 2008
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair
- ClinicalTrials.gov ID
- NCT01189708
- Acronym / sponsor ID
- EKSG08/006
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal aortic aneurysm, Abdominal hernia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Treatment without success, low enrollment, one serious adverse event
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh implantation | Experimental | Device: Ultrapro® Mesh implantationUltrapro® Mesh implantation |
| Standard wound closure without a mesh | Active comparator | Other: Standard wound closureStandard wound closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient scheduled for elective or early elective open repair of aortic aneurysm
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrapro® Mesh implantationAfter 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. | Device | Mesh implantation |
| Standard wound closureAbdominal closure will be performed with standard sutures without a mesh. | Other | Standard wound closure without a mesh |
Primary outcome
Incidence of incisional hernia
Time frame: 24 months
3 secondary outcomes
Rate of postoperative complications
Time frame: 7 days
operation time
Time frame: 4 hours
Rate of adverse events
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Treatment without success, low enrollment, one serious adverse event). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Nagel, MD principal investigator
KSSG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrapro® Mesh implantation and Standard wound closure in people with Abdominal Aortic Aneurysm, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Treatment without success, low enrollment, one serious adverse event). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of incisional hernia (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.