Clinical trial NCT00757133: Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment
Official title: Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2008-09-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: 2 years postoperatively
Secondary outcomes:
measure: Incidence of incisonal hernia
timeFrame: 1 year and 5 years after surgery
measure: VAS scores of pain at rest
timeFrame: 12, 24, 48, 72, 96, 120 hours , 4 weeks and 3 months after surgery
measure: Duration of surgery
timeFrame: After surgery
measure: Occurrence of post-operative complications
timeFrame: After 1 month
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Stedelijk Ziekenhuis Aalst
city: Antwerpen
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Ghent
country: Belgium
facility: AZ Maria Middelares Ghent
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Liège
country: Belgium
facility: CHU Sart Tilman
city: Wilrijk
country: Belgium
facility: Sint Augustinus (GZA ziekenhuizen)
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ Maria Middelares Ghent
name: Filip Muysoms, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.