Incisional HerniaАНЕУРИЗМАNCT02012270
Aneurysma Hernia Study - Incidence of Incisional Hernias After Abdominal Aortic Aneurysm Repair
An observational study of Incisional Hernia and Abdominal Aortic Aneurysm, run by Igor Koncar at 2 sites in 2 countries.
Trial summary
Principles= Prevention of incision hernias by primary closure of mid line laparotomies with the best-evidenced suture techniques. Background: Surgical practice of abdominal wall closure continues to rely largely on tradition rather than high-quality level I evidence. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incisional Hernia, Abdominal Aortic Aneurysm
- What is being tested?
- PRINCIPLES technique and Conventional group
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2012to Dec 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient operated due to Abdominal Aortic Aneurysm with open repair through laparotomy.
Who may be able to join
None listed.
Who cannot join
- patients not willing to take part in the follow up visits after informed consent no other exclusion criteria will be used (emergency, previous laparotomy or hernia repair)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Poland1 site
Medical University of Gdansk Dept. of Cardiac and Vascular Surgery
Gdansk
Serbia1 site
Clinic for Vascular and Endovascular Surgery, Serbian Clinical Centre
Belgrade, 11000
About this study
Official title: Prospective Case-control Study on the Incidence of Incisional Hernias at 12 Months After Closure of Midline Laparotomies in Patients Treated for Abdominal Aortic Aneurysm
Principles= Prevention of incision hernias by primary closure of mid line laparotomies with the best-evidenced suture techniques.
Background:
Read more
Surgical practice of abdominal wall closure continues to rely largely on tradition rather than high-quality level I evidence. Incisional hernia after laparotomy for treatment of abdominal aortic aneurysm (AAA) has a high incidence.
At this moment the best results in a prospective randomised clinical trial considering incision hernia rates and wound infections, have been reported by the surgeons from the Sundsvall clinic in Sweden. Their technique using a suture to wound length ratio of at least 4/1 and using many small stitches will be described in the protocol as the "Principles Technique". We want to explore if these results can indeed prevent incision hernias significantly if implemented with training and tutoring.
Methodology:Vascular surgeons,who are not using the principles yet, but show an interest to learn the Principles, will be asked to monitor a cohort of AAA patients using their current sutures and surgical techniques. Some of the vascular surgeons will undergo training and if wanted, proctoring during the first procedures using the Principles. A cohort of 120 AAA patients will be closed according to the Principles and monitored. The results of these 120 patients will be compared to the control group consisting of patients closed with the conventional technique by non---trained surgeons. Primary endpoint:The incidence of incision hernias at 12 months will be determined by clinical examination.
Data management and ownership:
The data will be collected on a paper form and will be introduced is a database (SPSS Statistics, IBM) from which statistical analysis will be made.
Read the detailed description
Principles= Prevention of incision hernias by primary closure of mid line laparotomies with the best-evidenced suture techniques.
Background:
Although many data from prospective studies have set some evidence-based principles to be adopted when closing mid line laparotomy incisions, these principles have not found a widespread implementation in the surgical community. Surgical practice continues to rely largely on tradition rather than high-quality level I evidence. Incision hernia after laparotomy for treatment of abdominal aortic aneurysm (AAA) has a high incidence of 10% to 37% depending on the method of follow up (clinically, with ultrasound or with CT scan) and the duration of follow up.
It is known that the surgical technique used to close the fascia in mid line laparotomies is an important parameter with regard to wound complications like wound infections and incision hernias. At this moment the best results in a prospective randomised clinical trial considering incisional hernia rates and wound infections, have been reported by the surgeons from the Sundsvall clinic in Sweden. Their technique using a suture to wound length ratio of at least 4/1 and using many small stitches will be described in the protocol as the "Principles Technique". We want to explore if these results can indeed prevent incision hernias significantly if implemented with training and tutoring.
Methodology:Vascular surgeons,who are not using the principles yet, but show an interest to learn the Principles, will be asked to monitor a cohort of AAA patients using their current sutures and surgical techniques. Some of the vascular surgeons will undergo training and if wanted, proctoring during the first procedures using the Principles. A cohort of 120 AAA patients will be closed according to the Principles and monitored. The results of these 120 patients will be compared to the control group consisting of patients closed with the conventional technique by non---trained surgeons. Study hypothesis and sample size calculation: Investigators might improve the incision hernia rate after AAA treatment through a mid line incision at 12 months by using the Principles from an estimated 25% in the conventionally closed patients to 10% in the patients closed using the Principles.
Calculation:
To show a decrease of 60% in the incision hernia rate at 12 months(25% vs 10% incision hernias at 12 months)with a power of 80% and a significance level of 5%, investigators need 100 evaluable patients at 12 months in each arm. To compensate a 20% lost to follow up, we have to include at least 120 patients before the "principles training" and 120 patients afterwards. So the trial will end inclusions when 120 AAA patients have been entered using the Principles. Most likely the control group will be larger than these 120 patients,depending on the number of vascular surgeons participating in the teaching course and the timing of this course.
Primary endpoint:The incidence of incision hernias at 12 months will be determined by clinical examination.
Data management and ownership:
The data will be collected on a paper form and will be introduced in a database (SPSS Statistics, IBM) from which statistical analysis will be made.
- Conditions
- Incisional Hernia, Abdominal Aortic Aneurysm
- Being tested
- PRINCIPLES technique, Conventional group
- Keywords
- Aortic Aneurysm, Hernia, Abdominal Wound Closure Techniques
- Medical subject headings
- Incisional Hernia, Aortic Aneurysm, Abdominal, Aortic Aneurysm, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRINCIPLES techniqueProcedure or surgery
Principles technique for closure of midline laparotomy incisions
- closure with a running suture of a slowly absorbable monofilament suture- Monomax 2/0 of 150 cm length with a taper needle point ((1/2 circle, size: 30mm) (B.Braun, reference 0041453)
- the suture is started and ended with a self-locking knot, if more than one suture is used sutures are knotted separately, only the fascia will be sutured with small stitches close to each other
- the SL/WL ratio should be at least 4/1
- SL/WL = (150cm x number of sutures used) - (the suture remnants)
- the mean stitch length should be less than 4 cm (suture length / number of stitches placed)
Conventional groupProcedure or surgery
the fascia will be closed with the current method by the surgeons. There will be a great variation in sutures and techniques used. Study group: the fascia will be closed according
| Study group | Role | What they receive |
|---|---|---|
| Conventional Group | Group of patients in whom after open AAA repair abdominal wall will be closed by conventional technique by the operating surgeons. There will be a great variation in sutures and techniques used Receives: Procedure: Conventional group | |
| PRINCIPLES Group | Group of patients in whom after open AAA repair abdominal wall will be closed by PRINCIPLES technique by the operating surgeons. Receives: Procedure: PRINCIPLES technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of incisional hernias
Incidence of incisional hernia after AAA repair after 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startFeb 2012
- Primary completionDec 2015
- Study completionDec 2015
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igor Koncar
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, Medical University of Gdansk
- Responsible party
- Sponsor-investigator, Igor Koncar, University of Belgrade
- Investigators
- Lazar Davidovic, Prof, Principal investigator, University of BelgradeZivan Maksimovic, Prof, Principal investigator, University of BelgradeFilip Muysoms, MD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012270
- Sponsor's protocol ID
- 175008
- Acronym
- АНЕУРИЗМА
- Status last verified
- Apr 2018
- First submitted
- 10 Dec 2013
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Case-control Study on the Incidence of Incisional Hernias at 12 Months After Closure of Midline Laparotomies in Patients Treated for Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT02012270
- Acronym / sponsor ID
- АНЕУРИЗМА / 175008
- Conditions
- Incisional Hernia, Abdominal Aortic Aneurysm
- Keywords
- Aortic Aneurysm, Hernia, Abdominal Wound Closure Techniques
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Igor KoncarUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, Medical University of Gdansk
- Study start
- Feb 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Dec 2013 (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.
Principles= Prevention of incision hernias by primary closure of mid line laparotomies with the best-evidenced suture techniques.
Background:
Surgical practice of abdominal wall closure continues to rely largely on tradition rather than high-quality level I evidence. Incisional hernia after laparotomy for treatment of abdominal aortic aneurysm (AAA) has a high incidence.
At this moment the best results in a prospective randomised clinical trial considering incision hernia rates and wound infections, have been reported by the surgeons from the Sundsvall clinic in Sweden. Their technique using a suture to wound length ratio of at least 4/1 and using many small stitches will be described in the protocol as the "Principles Technique". We want to explore if these results can indeed prevent incision hernias significantly if implemented with training and tutoring.
Methodology:Vascular surgeons,who are not using the principles yet, but show an interest to learn the Principles, will be asked to monitor a cohort of AAA patients using their current sutures and surgical techniques. Some of the vascular surgeons will undergo training and if wanted, proctoring during the first procedures using the Principles. A cohort of 120 AAA patients will be closed according to the Principles and monitored. The results of these 120 patients will be compared to the control group consisting of patients closed with the conventional technique by non---trained surgeons. Primary endpoint:The incidence of incision hernias at 12 months will be determined by clinical examination.
Data management and ownership:
The data will be collected on a paper form and will be introduced is a database (SPSS Statistics, IBM) from which statistical analysis will be made.
Detailed description
Principles= Prevention of incision hernias by primary closure of mid line laparotomies with the best-evidenced suture techniques.
Background:
Although many data from prospective studies have set some evidence-based principles to be adopted when closing mid line laparotomy incisions, these principles have not found a widespread implementation in the surgical community. Surgical practice continues to rely largely on tradition rather than high-quality level I evidence. Incision hernia after laparotomy for treatment of abdominal aortic aneurysm (AAA) has a high incidence of 10% to 37% depending on the method of follow up (clinically, with ultrasound or with CT scan) and the duration of follow up.
It is known that the surgical technique used to close the fascia in mid line laparotomies is an important parameter with regard to wound complications like wound infections and incision hernias. At this moment the best results in a prospective randomised clinical trial considering incisional hernia rates and wound infections, have been reported by the surgeons from the Sundsvall clinic in Sweden. Their technique using a suture to wound length ratio of at least 4/1 and using many small stitches will be described in the protocol as the "Principles Technique". We want to explore if these results can indeed prevent incision hernias significantly if implemented with training and tutoring.
Methodology:Vascular surgeons,who are not using the principles yet, but show an interest to learn the Principles, will be asked to monitor a cohort of AAA patients using their current sutures and surgical techniques. Some of the vascular surgeons will undergo training and if wanted, proctoring during the first procedures using the Principles. A cohort of 120 AAA patients will be closed according to the Principles and monitored. The results of these 120 patients will be compared to the control group consisting of patients closed with the conventional technique by non---trained surgeons. Study hypothesis and sample size calculation: Investigators might improve the incision hernia rate after AAA treatment through a mid line incision at 12 months by using the Principles from an estimated 25% in the conventionally closed patients to 10% in the patients closed using the Principles.
Calculation:
To show a decrease of 60% in the incision hernia rate at 12 months(25% vs 10% incision hernias at 12 months)with a power of 80% and a significance level of 5%, investigators need 100 evaluable patients at 12 months in each arm. To compensate a 20% lost to follow up, we have to include at least 120 patients before the "principles training" and 120 patients afterwards. So the trial will end inclusions when 120 AAA patients have been entered using the Principles. Most likely the control group will be larger than these 120 patients,depending on the number of vascular surgeons participating in the teaching course and the timing of this course.
Primary endpoint:The incidence of incision hernias at 12 months will be determined by clinical examination.
Data management and ownership:
The data will be collected on a paper form and will be introduced in a database (SPSS Statistics, IBM) from which statistical analysis will be made.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Group | – | Procedure: Conventional groupGroup of patients in whom after open AAA repair abdominal wall will be closed by conventional technique by the operating surgeons. There will be a great variation in sutures and techniques used |
| PRINCIPLES Group | – | Procedure: PRINCIPLES techniqueGroup of patients in whom after open AAA repair abdominal wall will be closed by PRINCIPLES technique by the operating surgeons. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient operated due to Abdominal Aortic Aneurysm with open repair through laparotomy.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- patients not willing to take part in the follow up visits after informed consent no other exclusion criteria will be used (emergency, previous laparotomy or hernia repair)
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 |
|---|---|---|
| PRINCIPLES techniquePrinciples technique for closure of midline laparotomy incisions * closure with a running suture of a slowly absorbable monofilament suture- Monomax 2/0 of 150 cm length with a taper needle point ((1/2 circle, size: 30mm) (B.Braun, reference 0041453) * the suture is started and ended with a self-locking knot, if more than one suture is used sutures are knotted separately, only the fascia will be sutured with small stitches close to each other * the SL/WL ratio should be at least 4/1 * SL/WL = (150cm x number of sutures used) - (the suture remnants) * the mean stitch length should be less than 4 cm (suture length / number of stitches placed) | Procedure or surgery | PRINCIPLES Group |
| Conventional groupthe fascia will be closed with the current method by the surgeons. There will be a great variation in sutures and techniques used. Study group: the fascia will be closed according | Procedure or surgery | Conventional Group |
Primary outcome
The incidence of incisional hernias
Time frame: 12 months
Incidence of incisional hernia after AAA repair after 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
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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.
Lazar Davidovic, Prof principal investigator
University of Belgrade
Zivan Maksimovic, Prof principal investigator
University of Belgrade
Filip Muysoms, MD principal investigator
University Ghent
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia and Abdominal Aortic Aneurysm, run by Igor Koncar at 2 sites in 2 countries.
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 0 inclusion and 1 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: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland, Serbia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of incisional hernias (time frame: 12 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 10 Apr 2018.