Aneurysma Hernia Study – Incidence of Incisional Hernias After Abdominal Aortic Aneurysm Repair

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Brief Title

Aneurysma Hernia Study - Incidence of Incisional Hernias After Abdominal Aortic Aneurysm Repair

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

Brief 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. 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 Type

Observational


Primary Outcome

The incidence of incisional hernias


Condition

Incisional Hernia

Intervention

PRINCIPLES technique

Study Arms / Comparison Groups

 Conventional Group
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

240

Start Date

February 2012

Completion Date

December 2015

Primary Completion Date

December 2015

Eligibility Criteria

        Inclusion Criteria:All patients undergoing treatment for an abdominal aortic aneurysm in
        the department of vascular surgery at the Serbian Clinical Centre in Beograd, Serbia,
        through midline laparotomies are eligible for the trial.

        Exclusion Criteria:

        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)
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Lazar Davidovic, Prof, , 

Location Countries

Poland

Location Countries

Poland

Administrative Informations


NCT ID

NCT02012270

Organization ID

175008


Responsible Party

Sponsor-Investigator

Study Sponsor

Igor Koncar

Collaborators

 University Hospital, Ghent

Study Sponsor

Lazar Davidovic, Prof, Principal Investigator, University of Belgrade


Verification Date

April 2018