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

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.

Conditions

• Incisional Hernia
• Abdominal Aortic Aneurysm

Interventions

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)

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

Sponsors & Collaborators

• University Hospital, Ghent

  collaborator OTHER

• Medical University of Gdansk

  collaborator OTHER

• Igor Koncar

  lead OTHER

Principal Investigators

• Lazar Davidovic, Prof · University of Belgrade

• Zivan Maksimovic, Prof · University of Belgrade

• Filip Muysoms, MD · University Ghent

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• Poland
• Serbia

Study Locations