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

NCT02012270 | Completed

• 1 other identifier: 175008
• Study Type: observational
• Target: 240
• Locations: 2 countries
• Sites: 2

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.

Conditions

Incisional Hernia; Abdominal Aortic Aneurysm

Keywords

Aortic Aneurysm; Hernia; Abdominal Wound Closure Techniques

Outcome Measures

Primary Outcomes (1)

• The incidence of incisional hernias

  Incidence of incisional hernia after AAA repair after 12 months

  12 months

Study Arms (2)

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

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

Interventions

PRINCIPLES technique PROCEDURE

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)

PRINCIPLES Group

Conventional group PROCEDURE

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

Conventional Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

Sponsors & Collaborators

• Igor Koncar: lead
• University Hospital, Ghent: collaborator
• Medical University of Gdansk: collaborator

Study Sites (2)

Medical University of Gdansk Dept. of Cardiac and Vascular Surgery

Gdansk, Poland

Location

Clinic for Vascular and Endovascular Surgery, Serbian Clinical Centre

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Incisional Hernia; Aortic Aneurysm, Abdominal; Aortic Aneurysm; Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Lazar Davidovic, Prof

  University of Belgrade

  PRINCIPAL INVESTIGATOR

• Zivan Maksimovic, Prof

  University of Belgrade

  PRINCIPAL INVESTIGATOR

• Filip Muysoms, MD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Igor Koncar

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 16, 2013
• Study Start: February 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

SE (1); PL (1)