PRIMA: Primary Mesh Closure of Abdominal Midline Wounds

Sponsor

Erasmus Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00761475

Collaborator

Baxter Healthcare Corporation (Industry), Aesculap AG (Industry)

480

Enrollment

Locations

Arms

73.9

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. Major risk factors for incisional hernia after a laparotomy, like obesity, steroid use, malnutrition, smoking and connective tissue disorders, are known. Despite this knowledge, there has not yet been developed a sufficient method for prevention. One specific group of high risk patients are patients with an abdominal aortic aneurysm (AAA). The relationship between aortic aneurysm and other abdominal wall hernias, like inguinal hernias, has been reported. Retrospective and prospective studies have shown an average risk for incisional hernia after AAA repair of 31.6 %. Another high risk group is the group of obese patients. Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after midline incision with an incidence of 22% after 12 months. Considering only 50 % of incisional hernia will be clinically evident in the first 12 months, the total incidence will be above 30%. This high risk group of patients with obesitas and aneurysmatic disease can benefit most from prevention. Some small studies have been performed to evaluate the usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk for incisional hernias and a low infection rate, even when used in contaminated wounds such as colostomal surgery. However, there has not been performed an adequate randomized controlled trial to study the prevention of incisional hernias. Our hypothesis is that incisional hernia prevention with use of prosthetic mesh after laparotomy is effective in patients with aortic aneurysm and in obese patients with a BMI of more than 27.

Condition or Disease	Intervention/Treatment	Phase
Incisional Hernia Occurence	Procedure: mesh supported closure Procedure: primary closure Procedure: mesh supported closure	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Primary Mesh Closure of Abdominal Midline Wounds; a Prospective Randomized Multicenter Trial

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 primary closure of the midline	Procedure: primary closure primary closure of the midline
Active Comparator: 2 onlay mesh supported closure	Procedure: mesh supported closure onlay mesh supported closure midline laparotomy
Active Comparator: 3 sublay mesh supported closure	Procedure: mesh supported closure sublay mesh supported closure midline laparotomy

Arm

Intervention/Treatment

Placebo Comparator: 1

primary closure of the midline

Procedure: primary closure

primary closure of the midline

Active Comparator: 2

onlay mesh supported closure

Procedure: mesh supported closure

onlay mesh supported closure midline laparotomy

Active Comparator: 3

sublay mesh supported closure

Procedure: mesh supported closure

sublay mesh supported closure midline laparotomy

Outcome Measures

Primary Outcome Measures

incisional hernia occurence [2 years]

Secondary Outcome Measures

complications [1 month]
post-operative pain [1 month]
quality of life [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Every elective midline laparotomy for patients with Abdominal Aortic Aneurysm and patients with a BMI of more than 27.
Signed informed consent

Exclusion Criteria:

Age < 18 years
Emergency procedure
Inclusion in other trials
Aortic reconstruction for obstructive disease
Life expectancy less than 24 months
Pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wilhelminenspital	Vienna		Austria
2	Berlin-Charite Universitatsklinikum	Berlin		Germany
3	Hamburg-Eppefdorf Universitatsklinikum	Hamburg		Germany
4	Heidelberg University Medical Center	Heidelberg		Germany
5	Munchen University Medical Center	Munchen		Germany
6	Erasmus Medical Center	Rotterdam	Zuid-Holland	Netherlands	3015 CE
7	IJsselland Ziekenhuis	Capelle a/d IJssel		Netherlands
8	Scheper Ziekenhuis	Emmen		Netherlands
9	Maasstad Ziekenhuis	Rotterdam		Netherlands
10	Sint Franciscus Gasthuis	Rotterdam		Netherlands
11	Maxima Medisch Centrum	Veldhoven		Netherlands
12	Isala klinieken	Zwolle		Netherlands

Sponsors and Collaborators

Erasmus Medical Center
Baxter Healthcare Corporation
Aesculap AG

Investigators

Principal Investigator: J.F. Lange, Professor, Erasmus Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hasan Eker, Prof. Dr. J.F. Lange, Erasmus Medical Center

ClinicalTrials.gov Identifier:

NCT00761475

Other Study ID Numbers:

PRIMA TRIAL

First Posted:

Sep 29, 2008

Last Update Posted:

Oct 28, 2016

Last Verified:

Oct 1, 2016

Keywords provided by Hasan Eker, Prof. Dr. J.F. Lange, Erasmus Medical Center

incisional hernia

Additional relevant MeSH terms:

Hernia

Incisional Hernia

Study Results

No Results Posted as of Oct 28, 2016