Primary Mesh Closure of Abdominal Midline Wounds (PRIMA)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Incisional Hernia Occurence |
Procedure: mesh supported closure Procedure: primary closure |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Primary Mesh Closure of Abdominal Midline Wounds; a Prospective Randomized Multicenter Trial |
- incisional hernia occurence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- complications [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- post-operative pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 460 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: L. Timmermans, MD | 0031107034519 | l.timmermans@erasmusmc.nl |
| Contact: H.H. Eker, MD | 0031628925554 | h.eker@erasmusmc.nl |
| Austria | |
| Wilhelminenspital | Recruiting |
| Vienna, Austria | |
| Contact: R Fortelny, MD, PhD | |
| Principal Investigator: R Fortelny, MD, PhD | |
| Germany | |
| Berlin-Charite Universitatsklinikum | Recruiting |
| Berlin, Germany | |
| Contact: P. Fikatas, MD panagiotis.fikatas@charite.de | |
| Contact: P. Neuhaus, Professor peter.neuhaus@charite.de | |
| Principal Investigator: P. Neuhaus, Professor | |
| Hamburg-Eppefdorf Universitatsklinikum | Recruiting |
| Hamburg, Germany | |
| Contact: A. Kutup, MD kutup@uke.de | |
| Contact: J. Izbicki, Professor izbicki@uke.de | |
| Principal Investigator: J. Izbicki, Professor | |
| Heidelberg University Medical Center | Recruiting |
| Heidelberg, Germany | |
| Contact: Ch M Seiler, MD, PhD | |
| Principal Investigator: Ch M Seiler, MD, PhD | |
| Munchen University Medical Center | Recruiting |
| Munchen, Germany | |
| Contact: A. Mihaljevic, MD amihalje@googlemail.com | |
| Contact: C. Schumacher, Professor Schuhmacher@chir.med.tu-muenchen.de | |
| Principal Investigator: C. Schumacher, Professor | |
| Netherlands | |
| Erasmus Medical Center | Recruiting |
| Rotterdam, Zuid-Holland, Netherlands, 3015 CE | |
| Contact: L. Timmermans, MD 0031107034519 l.timmermans@erasmusmc.nl | |
| Contact: H.H. Eker, MD 0031628925554 h.eker@erasmusmc.nl | |
| Sub-Investigator: HH Eker, MD | |
| Principal Investigator: JF Lange, MD, Professor | |
| Sub-Investigator: L. Timmermans, MD | |
| IJsselland Ziekenhuis | Recruiting |
| Capelle a/d IJssel, Netherlands | |
| Contact: I Dawson, MD, PhD | |
| Principal Investigator: I Dawson, MD, PhD | |
| Scheper Ziekenhuis | Recruiting |
| Emmen, Netherlands | |
| Contact: M. van der Berg, MD, PhD m.vanderberg@sze.nl | |
| Principal Investigator: M. van der Berg, MD, PhD | |
| Maasstad Ziekenhuis | Recruiting |
| Rotterdam, Netherlands | |
| Contact: P. Timmers, MD, PhD TimmersP@maasstadziekenhuis.nl | |
| Principal Investigator: P. Timmers, MD, PhD | |
| Sint Franciscus Gasthuis | Recruiting |
| Rotterdam, Netherlands | |
| Contact: A vd Ham, MD, PhD | |
| Principal Investigator: A vd Ham, MD, PhD | |
| Maxima Medisch Centrum | Recruiting |
| Veldhoven, Netherlands | |
| Contact: J Charbon, MD, PhD | |
| Principal Investigator: J Charbon, MD, PhD | |
| Isala klinieken | Recruiting |
| Zwolle, Netherlands | |
| Contact: E.G.J.M. Pierik, MD,PhD e.g.j.m.pierik@isala.nl | |
| Contact: S.S. Lases, MD s.s.lases@isala.nl | |
| Principal Investigator: E.G.J.M. Pierik, MD,PhD | |
| Principal Investigator: | J.F. Lange, Professor | Erasmus Medical Center, Rotterdam |
More Information
No publications provided
| Responsible Party: | hasan eker, Prof. Dr. J.F. Lange, Erasmus Medical Center |
| ClinicalTrials.gov Identifier: | NCT00761475 History of Changes |
| Other Study ID Numbers: | PRIMA TRIAL |
| Study First Received: | September 26, 2008 |
| Last Updated: | November 11, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Erasmus Medical Center:
|
incisional hernia |
Additional relevant MeSH terms:
|
Hernia Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013