Skip to main content
OpenTrials
Completed

NCT Number: NCT00757133

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Aneurysm Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stedelijk Ziekenhuis Aalst, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional laparotomy closure

Procedure

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 augmentation

Procedure

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"

Primary outcomes

  1. 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

  1. Incidence of incisonal hernia

    Time frame: 1 year and 5 years after surgery

  2. VAS scores of pain at rest

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

  3. Duration of surgery

    Time frame: After surgery

  4. Occurrence of post-operative complications

    Time frame: After 1 month

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

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

Acronym: PRIMAAT

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Sep 22, 2008
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.