Clinical trial NCT00761475: Primary Mesh Closure of Abdominal Midline Wounds
Official title: Primary Mesh Closure of Abdominal Midline Wounds; a Prospective Randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Incisional Hernia Occurence
Keywords: incisional hernia
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
name: Aesculap AG
First posted: 2008-09-29
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: incisional hernia occurence
timeFrame: 2 years
Secondary outcomes:
measure: complications
timeFrame: 1 month
measure: post-operative pain
timeFrame: 1 month
measure: quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Wilhelminenspital
city: Berlin
country: Germany
facility: Berlin-Charite Universitatsklinikum
city: Hamburg
country: Germany
facility: Hamburg-Eppefdorf Universitatsklinikum
city: Heidelberg
country: Germany
facility: Heidelberg University Medical Center
city: Munchen
country: Germany
facility: Munchen University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
city: Capelle a/d IJssel
country: Netherlands
facility: IJsselland Ziekenhuis
city: Emmen
country: Netherlands
facility: Scheper Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Gasthuis
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Zwolle
country: Netherlands
facility: Isala klinieken
Study officials:
affiliation: Erasmus Medical Center
name: J.F. Lange, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jairam AP, Timmermans L, Eker HH, Pierik REGJM, van Klaveren D, Steyerberg EW, Timman R, van der Ham AC, Dawson I, Charbon JA, Schuhmacher C, Mihaljevic A, Izbicki JR, Fikatas P, Knebel P, Fortelny RH, Kleinrensink GJ, Lange JF, Jeekel HJ; PRIMA Trialist Group. Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind, randomised controlled trial. Lancet. 2017 Aug 5;390(10094):567-576. doi: 10.1016/S0140-6736(17)31332-6. Epub 2017 Jun 20.
citation: Timmermans L, Eker HH, Steyerberg EW, Jairam A, de Jong D, Pierik EG, Lases SS, van der Ham AC, Dawson I, Charbon J, Schuhmacher C, Izbicki JR, Neuhaus P, Knebel P, Fortelny R, Kleinrensink GJ, Jeekel J, Lange JF. Short-term results of a randomized controlled trial comparing primary suture with primary glued mesh augmentation to prevent incisional hernia. Ann Surg. 2015 Feb;261(2):276-81. doi: 10.1097/SLA.0000000000000798.
citation: Nieuwenhuizen J, Eker HH, Timmermans L, Hop WC, Kleinrensink GJ, Jeekel J, Lange JF; PRIMA Trialist Group. A double blind randomized controlled trial comparing primary suture closure with mesh augmented closure to reduce incisional hernia incidence. BMC Surg. 2013 Oct 28;13:48. doi: 10.1186/1471-2482-13-48.