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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Belgrade
Sponsor:
Collaborators:
University Hospital, Ghent
Medical University of Gdansk
Information provided by (Responsible Party):
Igor Koncar, University of Belgrade
ClinicalTrials.gov Identifier:
NCT02012270
First received: December 10, 2013
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Incisional Hernia
Abdominal Aortic Aneurysm
Procedure: PRINCIPLES technique
Procedure: Conventional group

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Belgrade:

Primary Outcome Measures:
  • The incidence of incisional hernias [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Incidence of incisional hernia after AAA repair after 12 months


Estimated Enrollment: 240
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Procedure: Conventional group
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
PRINCIPLES Group
Group of patients in whom after open AAA repair abdominal wall will be closed by PRINCIPLES technique by the operating surgeons.
Procedure: PRINCIPLES technique

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)

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patient operated due to Abdominal Aortic Aneurysm with open repair through laparotomy.

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012270

Locations
Poland
Medical University of Gdansk Dept. of Cardiac and Vascular Surgery Recruiting
Gdansk, Poland
Contact: Kamil Bury, PhD    +48 601 213 010    kamilbury@me.com   
Principal Investigator: Kamil Bury, PhD         
Serbia
Clinic for Vascular and Endovascular Surgery, Serbian Clinical Centre Recruiting
Belgrade, Serbia, 11000
Contact: Igor Koncar, MD    +381668300290    dr.koncar@gmail.com   
Sub-Investigator: Igor Koncar, MD         
Sponsors and Collaborators
Igor Koncar
University Hospital, Ghent
Medical University of Gdansk
Investigators
Principal Investigator: Lazar Davidovic, Prof University of Belgrade
Principal Investigator: Zivan Maksimovic, Prof University of Belgrade
Principal Investigator: Filip Muysoms, MD University of Ghent
  More Information

No publications provided

Responsible Party: Igor Koncar, University of Belgrade
ClinicalTrials.gov Identifier: NCT02012270     History of Changes
Other Study ID Numbers: 175008
Study First Received: December 10, 2013
Last Updated: December 13, 2013
Health Authority: Serbia: Ethics Committee

Keywords provided by University of Belgrade:
Aortic Aneurysm
Hernia
Abdominal Wound Closure Techniques

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Hernia
Aortic Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014