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

Primary Purpose

Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Conventional laparotomy closure
Laparotomy closure with mesh augmentation
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stedelijk Ziekenhuis Aalst
  • Universitair Ziekenhuis Antwerpen
  • Imelda Ziekenhuis
  • AZ Maria Middelares Ghent
  • University Hospital Ghent
  • Universitair Ziekenhuis Leuven
  • CHU Sart Tilman
  • Sint Augustinus (GZA ziekenhuizen)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Conventional laparotomy closure

Laparotomy closure with mesh augmentation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of incisonal hernia
VAS scores of pain at rest
Duration of surgery
Occurrence of post-operative complications

Full Information

First Posted
September 18, 2008
Last Updated
December 4, 2014
Sponsor
University Hospital, Ghent
Collaborators
Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT00757133
Brief Title
Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment
Acronym
PRIMAAT
Official Title
Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Johnson & Johnson

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Conventional laparotomy closure
Arm Title
2
Arm Type
Active Comparator
Arm Description
Laparotomy closure with mesh augmentation
Intervention Type
Procedure
Intervention Name(s)
Conventional laparotomy closure
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Laparotomy closure with mesh augmentation
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Incidence of incisonal hernia
Time Frame
1 year and 5 years after surgery
Title
VAS scores of pain at rest
Time Frame
12, 24, 48, 72, 96, 120 hours , 4 weeks and 3 months after surgery
Title
Duration of surgery
Time Frame
After surgery
Title
Occurrence of post-operative complications
Time Frame
After 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Berrevoet, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Filip Muysoms, MD
Organizational Affiliation
AZ Maria Middelares Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stedelijk Ziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Imelda Ziekenhuis
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ Maria Middelares Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Sint Augustinus (GZA ziekenhuizen)
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
26943336
Citation
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.
Results Reference
derived
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent

Learn more about this trial

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

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