Primary Mesh Closure of Abdominal Midline Wounds (PRIMA)

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

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.

Study Overview

• Status: Completed
• Conditions: Incisional Hernia Occurence
• Intervention / Treatment: Procedure: primary closure; Procedure: mesh supported closure; Procedure: mesh supported closure

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Wilhelminenspital
• Germany
  • Berlin, Germany
    • Berlin-Charite Universitatsklinikum
  • Hamburg, Germany
    • Hamburg-Eppefdorf Universitatsklinikum
  • Heidelberg, Germany
    • Heidelberg University Medical Center
  • Munchen, Germany
    • Munchen University Medical Center
• Netherlands
  • Capelle a/d IJssel, Netherlands
    • IJsselland ziekenhuis
  • Emmen, Netherlands
    • Scheper Ziekenhuis
  • Rotterdam, Netherlands
    • Maasstad Ziekenhuis
  • Rotterdam, Netherlands
    • Sint Franciscus Gasthuis
  • Veldhoven, Netherlands
    • Maxima Medisch Centrum
  • Zwolle, Netherlands
    • Isala Klinieken
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 CE
      • Erasmus Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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; Procedure: mesh supported closure; sublay mesh supported closure midline laparotomy
Active Comparator: 3; sublay mesh supported closure	Procedure: mesh supported closure; onlay mesh supported closure midline laparotomy; Procedure: mesh supported closure; sublay mesh supported closure midline laparotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incisional hernia occurence	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
quality of life	2 years
complications	1 month
post-operative pain	1 month

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Baxter Healthcare Corporation; Aesculap AG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 26, 2008
• First Posted (Estimate): September 29, 2008

Study Record Updates

• Last Update Posted (Estimate): October 28, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: incisional hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: PRIMA TRIAL