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

Aortic Aneurysm Clinical Trial

— PRIMAAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757133
• Other study ID #: 2008/379
• Status: Completed
• Phase: N/A
• First received: September 18, 2008
• Last updated: December 4, 2014
• Start date: November 2008
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

Intervention

Procedure:
• Conventional laparotomy closure
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
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"

Locations

Country	Name	City	State
Belgium	Stedelijk Ziekenhuis Aalst	Aalst
Belgium	Universitair Ziekenhuis Antwerpen	Antwerpen
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	AZ Maria Middelares Ghent	Ghent
Belgium	University Hospital Ghent	Ghent
Belgium	Universitair Ziekenhuis Leuven	Leuven
Belgium	CHU Sart Tilman	Liège
Belgium	Sint Augustinus (GZA ziekenhuizen)	Wilrijk

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Johnson & Johnson

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 years postoperatively	Yes
Secondary	Incidence of incisonal hernia		1 year and 5 years after surgery	Yes
Secondary	VAS scores of pain at rest		12, 24, 48, 72, 96, 120 hours , 4 weeks and 3 months after surgery	No
Secondary	Duration of surgery		After surgery	No
Secondary	Occurrence of post-operative complications		After 1 month	Yes

External Links

•   Website of the University Hospital Ghent