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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm
• Intervention / Treatment: Procedure: Conventional laparotomy closure; Procedure: Laparotomy closure with mesh augmentation

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Stedelijk Ziekenhuis Aalst
  • Antwerpen, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Bonheiden, Belgium, 2820
    • Imelda Ziekenhuis
  • Ghent, Belgium, 9000
    • University Hospital Ghent
  • Ghent, Belgium, 9000
    • AZ Maria Middelares Ghent
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven
  • Liège, Belgium, 4000
    • CHU Sart Tilman
  • Wilrijk, Belgium, 2610
    • Sint Augustinus (GZA ziekenhuizen)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Conventional laparotomy closure	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
Active Comparator: 2; Laparotomy closure with mesh augmentation	Procedure: 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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of incisonal hernia	1 year and 5 years after surgery
VAS scores of pain at rest	12, 24, 48, 72, 96, 120 hours , 4 weeks and 3 months after surgery
Duration of surgery	After surgery
Occurrence of post-operative complications	After 1 month

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Johnson & Johnson
• Investigators: Principal Investigator: Filip Muysoms, MD, AZ Maria Middelares Ghent

Publications and helpful links

General Publications

• Muysoms FE, Detry O, Vierendeels T, Huyghe M, Miserez M, Ruppert M, Tollens T, Defraigne JO, Berrevoet F. Prevention of Incisional Hernias by Prophylactic Mesh-augmented Reinforcement of Midline Laparotomies for Abdominal Aortic Aneurysm Treatment: A Randomized Controlled Trial. Ann Surg. 2016 Apr;263(4):638-45. doi: 10.1097/SLA.0000000000001369.

Helpful Links

• Website of the University Hospital Ghent

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 18, 2008
• First Submitted That Met QC Criteria: September 18, 2008
• First Posted (Estimate): September 22, 2008

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Aortic Diseases; Aneurysm; Incisional Hernia; Aortic Aneurysm
• Other Study ID Numbers: 2008/379