Incisional HerniaNCT01507870
Randomized Controlled Prospective Multicenter Study Primary Onlay- Mesh After Elective Median Laparotomy in Patients With BMI ≥ 27
A study testing onlay mesh placement in people with Incisional Hernia and Obesity, run by Austrian Hernia Study Group at 1 site in Austria.
Trial summary
Incisional hernia is one ot the most frequently seen long term complications in abdominal surgery. Despite studies on the optimal suturing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia, Obesity
- What is being tested?
- onlay mesh placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2010to Jan 2013
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Every elective midline laparotomy for patients with a BMI of more than 27. Signed informed consent
- Previous midline incision
- Life expectancy less than 24 months
- Pregnant women
- Immune suppression therapy within 2 weeks before surgery
Who cannot join
- Age < 18 years
- Emergency procedure
Trial locations and contacts
1 site in 1 country.
About this study
Incisional hernia is one ot the most frequently seen long term complications in abdominal surgery. Despite studies on the optimal suturing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. One major risk factor for incisional hernia after a median laparotomy is obesity.
The closure technique of midline incisions has remained unchanged since many decades and primarily consists of suturing the linea alba. Interest in prevention of incisional hernias with the aid of synthetic mesh is growing and only one large randomized trial is active recruiting patients in Germany, Netherlands and Belgium (Prima Trial).
Read more
Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after midline incision with an incidence of 22% after 12 months. This high risk group of patients may benefit from prevention.
Some small studies have been performed to evaluate the usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk for incisional hernias and a low infection rate, even when used in contaminated wounds such as colostomy surgery.
The goal of this study is to evaluate the effectiveness of incisional hernia prevention after elective median laparotomy in patients with a BMI of more than 27. A randomized controlled trial will be performed comparing the commonly used technique of running suture to close with the aid of a prosthetic onlay mesh. The primary outcome measure will be incisional hernia occurrence. Secondary outcome measures will be complications, surgical site infections, post-operative pain and quality of life.
- Conditions
- Incisional Hernia, Obesity
- Being tested
- onlay mesh placement
- Keywords
- body mass index
- Medical subject headings
- Incisional Hernia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onlay mesh placementProcedure or surgery
prophylactic onlay mesh in patients with median laparotomy
| Study group | Role | What they receive |
|---|---|---|
| prophylactic onlay mesh | Active comparator | Not described Receives: Procedure: onlay mesh placement |
| continuous running suture | No intervention | continuous running suture of the linea alba |
What is being measured
The primary outcome is the main question the study is designed to answer.
incisional hernia occurrence
Measured: 3 years
Secondary outcomes (3)
complications
haematoma formation, seroma formation, surgical site infection (SSI - classification)
Measured: 3 years
postoperative pain
VAS
Measured: 14 days postoperative
life quality
MOS SF-36
Measured: 14 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Austrian Hernia Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Herwig Pokorny, Austrian Hernia Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507870
- Sponsor's protocol ID
- Primary Onlay
- Status last verified
- Jul 2015
- First submitted
- 5 Jan 2012
- Last updated
- 2 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Prospective Multicenter Study Primary Onlay- Mesh After Elective Median Laparotomy in Patients With BMI ≥ 27
- ClinicalTrials.gov ID
- NCT01507870
- Acronym / sponsor ID
- Primary Onlay
- Conditions
- Incisional Hernia, Obesity
- Keywords
- body mass index
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Austrian Hernia Study GroupUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Jan 2012 (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.
Incisional hernia is one ot the most frequently seen long term complications in abdominal surgery. Despite studies on the optimal suturing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. One major risk factor for incisional hernia after a median laparotomy is obesity.
The closure technique of midline incisions has remained unchanged since many decades and primarily consists of suturing the linea alba. Interest in prevention of incisional hernias with the aid of synthetic mesh is growing and only one large randomized trial is active recruiting patients in Germany, Netherlands and Belgium (Prima Trial).
Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after midline incision with an incidence of 22% after 12 months. This high risk group of patients may benefit from prevention.
Some small studies have been performed to evaluate the usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk for incisional hernias and a low infection rate, even when used in contaminated wounds such as colostomy surgery.
The goal of this study is to evaluate the effectiveness of incisional hernia prevention after elective median laparotomy in patients with a BMI of more than 27. A randomized controlled trial will be performed comparing the commonly used technique of running suture to close with the aid of a prosthetic onlay mesh. The primary outcome measure will be incisional hernia occurrence. Secondary outcome measures will be complications, surgical site infections, post-operative pain and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prophylactic onlay mesh | Active comparator | Procedure: onlay mesh placement |
| continuous running suture | No intervention | –continuous running suture of the linea alba |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Every elective midline laparotomy for patients with a BMI of more than 27. Signed informed consent
- Previous midline incision
- Life expectancy less than 24 months
- Pregnant women
- Immune suppression therapy within 2 weeks before surgery
Key exclusion criteria (2 listed)
- Age < 18 years
- Emergency procedure
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 |
|---|---|---|
| onlay mesh placementprophylactic onlay mesh in patients with median laparotomy | Procedure or surgery | prophylactic onlay mesh |
Primary outcome
incisional hernia occurrence
Time frame: 3 years
3 secondary outcomes
complications
Time frame: 3 years
postoperative pain
Time frame: 14 days postoperative
life quality
Time frame: 14 days postoperative
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing onlay mesh placement in people with Incisional Hernia and Obesity, run by Austrian Hernia Study Group at 1 site in Austria.
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 5 inclusion and 2 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 2 Jul 2015. 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 Austria. 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. 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?
incisional hernia occurrence (time frame: 3 years). 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 2 Jul 2015.