Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment

University Hospital, Ghent120 enrolled

Overview

The research hypothesis for this study is to possibly reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy. The study is designed as a prospective randomised multi-centre trial, randomising patients in 2 groups concerning the surgical technique of the closure of the abdominal wall.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Aortic Aneurysm

Interventions

Conventional laparotomy closurePROCEDURE

Recommended technique: The laparotomy is closed with a slowly resorbable running suture (f.e. PDS) in a single layer. The length of the suture should approximately be four (4) times the length of the fascial incision. The skin is closed with the usual technique of the department

Laparotomy closure with mesh augmentationPROCEDURE

Recommended technique: Mesh augmentation can be done in a retromuscular or a prefascial position. By consensus of the initial primary investigators a retromuscular (sublay) position of the mesh was chosen and as a mesh a light weight polypropylene mesh will be used. Retromuscular (sublay): (see reference no. 11: Rogers et al.) At the end of the vascular procedure the plane behind the rectus muscles (retromuscular-preperitoneal) is dissected as in a "Stoppa repair for incisional hernias"

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients undergoing elective Abdominal Aorta Aneurysm treatment through a midline laparotomy are eligible for the trial. * All patients should sign the informed consent. Exclusion Criteria: * Patients below 18 years. * Pregnancy. * Emergency surgery for aortic aneurysm. * Presence of mesh in the abdominal wall on the midline from previous operations ASA score 4 or more.

Locations (8)

Stedelijk Ziekenhuis Aalst

Aalst, Belgium

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Imelda Ziekenhuis

Bonheiden, Belgium

AZ Maria Middelares Ghent

Ghent, Belgium

Outcomes

Primary Outcomes

To reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy Incidence of incisonal hernia

Time frame: 2 years postoperatively

Secondary Outcomes

Incidence of incisonal hernia

Time frame: 1 year and 5 years after surgery

VAS scores of pain at rest

Time frame: 12, 24, 48, 72, 96, 120 hours , 4 weeks and 3 months after surgery

Duration of surgery

Time frame: After surgery

Occurrence of post-operative complications

Time frame: After 1 month

Data from ClinicalTrials.gov

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