Prophylactic Mesh to Reduce The Incidence of Ventral Hernia

Overview

The incidence of ventral hernias has remained inappropriately high. Any innovation in order to reduce this incidence would be simply cost-effective. Although there is still some concern about the use of mesh in clean-contaminated or contaminated surgery, based in our experimental studies, we plan to use a mesh in the primary closure of abdominal incision to prevent incisional hernias. The investigators propose a clinical trial to assess a model to prevent the incisional hernia after laparotomy to treat colorectal carcinoma is scheduled. A simple randomization is scheduled: in the intervention group a prefascial large-pore low-weight 5 cm wide polypropylene mesh is fixed covering the midline closure; in the control group a conventional closure with a running suture of long-term absorbable material with a suture/wound length ratio 4:1. The sample size was calculated with an estimated incidence of ventral hernia of 25% in the control group and 10% in the intervention group, 0,05 alfa and a 0,15 beta error. The main goal is the appearance of a ventral hernia after 24 months of follow-up. Other outcomes are wound complications and morbidity. Exclusion criteria are adult patients with a previous ventral hernia, estimated survival of less than 6 months or hemodynamic instability during surgery. The diagnosis of ventral hernia will be assessed by clinical exploration on 3,6,12,18 and 24 months and abdominal CT controls at 6,12, and 24 months. The study will be statistically evaluated with SPSS 18.0.

Full Title of Study: “Randomized Clinical Trial to Evaluate the Use of a Prophylactic Polypropylene Mesh To Reduce the Incidence of Ventral Hernias in Colorectal Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2011

Interventions

  • Procedure: Prophylactic mesh
    • Closure of midline laparotomy using a prophylactic mesh. The midline is closed with a running absorbable monofilament suture with a suture/wound length ratio 4:1. The material is a monofilament uncoated suture made of poly-4hiydroxybutirate (Monomax, B.Braun) USP 1. Then, a prefascial large-pore low-weight 5 cm wide polypropylene mesh (Optilene Mesh Elastic, B.Braun) is fixed covering the midline closure. The mesh is fixed in the prefascial plane with absorbable monofilament interrupted sutures, USP 2/0.
  • Procedure: No prophylactic mesh closure
    • Closure of midline laparotomy without mesh. The laparotomy is closed with a running absorbable monofilament suture with a suture/wound length ratio 4:1. The material is a monofilament uncoated suture made of poly-4hiydroxybutirate (Monomax, B.Braun) USP 1.

Arms, Groups and Cohorts

  • Experimental: Prophylactic Mesh
    • Use of a prefascial polypropylene mesh when closing midline laparotomy
  • Experimental: No prophylactic mesh closure
    • In this arm the laparotomy of the patients are closed with a running absorbable suture without a mesh

Clinical Trial Outcome Measures

Primary Measures

  • Compare the incidence of ventral hernia between the 2 groups
    • Time Frame: 24 months
    • Compare the incidence of ventral hernias at the end of the second year follow-up in patients operated for laparotomy using two different methods of abdominal wall closure: one with mesh reinforcement and another one with no mesh reinforcement

Secondary Measures

  • Incidence of superficial surgical site infection
    • Time Frame: 30 days
    • Compare the incidence of superficial surgical site infection between the 2 groups
  • Incidence of deep surgical site infection
    • Time Frame: 30 days
    • Compare the incidence of deep surgical site infection between the 2 groups
  • Seroma
    • Time Frame: 30 days
    • Incidence of postoperative seroma
  • Postoperative complications
    • Time Frame: 30 days
    • Register of postoperative complications, including pulmonary, fistula and postoperative ileum

Participating in This Clinical Trial

Inclusion Criteria

  • More than 18 years old. – Patients operated with elective or emergency midline laparotomy with the diagnosis of colorectal cancer. – Written informed consent or oral consent with the present of two witnesses who do not participate as investigators in the trial Exclusion Criteria:

  • Dissemination of oncologic disease: all stage IV tumors with estimated survival less than 3 months. – Simultaneous participation in another trial with interference of intervention and outcome. – Withdrawn or missing written consent. – Mental condition rendering the subject incapable of understanding the nature, scope and consequences of the trial. – Previous ventral hernia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Henares University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Miguel A ngel Garci-a Urena, Professor – Henares University Hospital
  • Overall Official(s)
    • Miguel Ángel García-Ureña, Professor, Principal Investigator, Henares University Hospital

References

Strzelczyk JM, Szymanski D, Nowicki ME, Wilczynski W, Gaszynski T, Czupryniak L. Randomized clinical trial of postoperative hernia prophylaxis in open bariatric surgery. Br J Surg. 2006 Nov;93(11):1347-50. doi: 10.1002/bjs.5512.

Stringer RA, Salameh JR. Mesh herniorrhaphy during elective colorectal surgery. Hernia. 2005 Mar;9(1):26-8. doi: 10.1007/s10029-004-0274-x. Epub 2004 Sep 10.

Gutierrez de la Pena C, Medina Achirica C, Dominguez-Adame E, Medina Diez J. Primary closure of laparotomies with high risk of incisional hernia using prosthetic material: analysis of usefulness. Hernia. 2003 Sep;7(3):134-6. doi: 10.1007/s10029-003-0124-2. Epub 2003 Apr 3.

O'Hare JL, Ward J, Earnshaw JJ. Late results of mesh wound closure after elective open aortic aneurysm repair. Eur J Vasc Endovasc Surg. 2007 Apr;33(4):412-3. doi: 10.1016/j.ejvs.2006.11.015. Epub 2006 Dec 11.

Bellon JM, Lopez-Hervas P, Rodriguez M, Garcia-Honduvilla N, Pascual G, Bujan J. Midline abdominal wall closure: a new prophylactic mesh concept. J Am Coll Surg. 2006 Oct;203(4):490-7. doi: 10.1016/j.jamcollsurg.2006.06.023. Epub 2006 Aug 23.

Israelsson LA, Millbourn D. Closing midline abdominal incisions. Langenbecks Arch Surg. 2012 Dec;397(8):1201-7. doi: 10.1007/s00423-012-1019-4. Epub 2012 Nov 11.

Diaz-Godoy A, Garcia-Urena MA, Lopez-Monclus J, Vega Ruiz V, Melero Montes D, Erquinigo Agurto N. Searching for the best polypropylene mesh to be used in bowel contamination. Hernia. 2011 Apr;15(2):173-9. doi: 10.1007/s10029-010-0762-0. Epub 2010 Dec 9.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.