NCT00757133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

5.1 years

First QC Date

September 18, 2008

Last Update Submit

December 4, 2014

Conditions

Aortic Aneurysm

Outcome Measures

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

    2 years postoperatively

Secondary Outcomes (4)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Conventional laparotomy closure

Procedure: Conventional laparotomy closure

2

ACTIVE COMPARATOR

Laparotomy closure with mesh augmentation

Procedure: Laparotomy closure with mesh augmentation

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

1
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"

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing elective Abdominal Aorta Aneurysm treatment through a midline laparotomy are eligible for the trial.
  • All patients should sign the informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Stedelijk Ziekenhuis Aalst

Aalst, 9300, Belgium

Location

Universitair Ziekenhuis Antwerpen

Antwerp, 2650, Belgium

Location

Imelda Ziekenhuis

Bonheiden, 2820, Belgium

Location

AZ Maria Middelares Ghent

Ghent, 9000, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

Location

CHU Sart Tilman

Liège, 4000, Belgium

Location

Sint Augustinus (GZA ziekenhuizen)

Wilrijk, 2610, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 26943336DERIVED

Related Links

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Frederik Berrevoet, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

  • Filip Muysoms, MD

    AZ Maria Middelares Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2008

First Posted

September 22, 2008

Study Start

November 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

BE(8)