Primary Mesh Closure of Abdominal Midline Wounds (PRIMA)

• ClinicalTrials.gov Identifier: NCT00761475
• Recruitment Status: Completed
• First Posted: September 29, 2008
• Last Update Posted: October 28, 2016
• Sponsor: Erasmus Medical Center
• Collaborators: Baxter Healthcare Corporation; Aesculap AG
• Information provided by (Responsible Party): Hasan Eker, Erasmus Medical Center

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	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: February 2009
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: April 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

Outcome Measures

Primary Outcome Measures :

1. incisional hernia occurence [ Time Frame: 2 years ]

Secondary Outcome Measures :

1. complications [ Time Frame: 1 month ]
2. post-operative pain [ Time Frame: 1 month ]
3. quality of life [ Time Frame: 2 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Austria

Wilhelminenspital

Vienna, Austria

Germany

Berlin-Charite Universitatsklinikum

Berlin, Germany

Hamburg-Eppefdorf Universitatsklinikum

Hamburg, Germany

Heidelberg University Medical Center

Heidelberg, Germany

Munchen University Medical Center

Munchen, Germany

Netherlands

Erasmus Medical Center

Rotterdam, Zuid-Holland, Netherlands, 3015 CE

IJsselland Ziekenhuis

Capelle a/d IJssel, Netherlands

Scheper Ziekenhuis

Emmen, Netherlands

Maasstad Ziekenhuis

Rotterdam, Netherlands

Sint Franciscus Gasthuis

Rotterdam, Netherlands

Maxima Medisch Centrum

Veldhoven, Netherlands

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum in: Lancet. 2017 Aug 5;390(10094):554.

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.

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.

• Responsible Party: Hasan Eker, Prof. Dr. J.F. Lange, Erasmus Medical Center
• ClinicalTrials.gov Identifier: NCT00761475
• Other Study ID Numbers: PRIMA TRIAL
• First Posted: September 29, 2008
• Last Update Posted: October 28, 2016
• Last Verified: October 2016

Keywords provided by Hasan Eker, Erasmus Medical Center:

incisional hernia

Additional relevant MeSH terms:

Hernia; Incisional Hernia; Pathological Conditions, Anatomical; Postoperative Complications; Pathologic Processes