Prophylactic Mesh to Reduce The Incidence of Ventral Hernia

NCT01788826 | Unknown DMC

• 1 other identifier: HH01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventral Hernia

Keywords

Ventral hernia; surgical meshes; polypropylenes

Outcome Measures

Primary Outcomes (1)

• Compare the incidence of ventral hernia between the 2 groups

  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

  24 months

Secondary Outcomes (4)

• Incidence of superficial surgical site infection

  30 days

• Incidence of deep surgical site infection

  30 days

• Seroma

  30 days

• Postoperative complications

  30 days

Study Arms (2)

Prophylactic Mesh

EXPERIMENTAL

Use of a prefascial polypropylene mesh when closing midline laparotomy

Procedure: Prophylactic mesh

No prophylactic mesh closure

EXPERIMENTAL

In this arm the laparotomy of the patients are closed with a running absorbable suture without a mesh

Procedure: No prophylactic mesh closure

Interventions

Prophylactic mesh PROCEDURE

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.

Prophylactic Mesh

No prophylactic mesh closure PROCEDURE

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.

No prophylactic mesh closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henares University Hospital: lead

Study Sites (1)

Henares University Hospital

Coslada, Madrid, 28522, Spain

Location

Related Publications (7)

• 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.

  PMID: 17006977 BACKGROUND

• 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.

  PMID: 15365881 BACKGROUND

• 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.

  PMID: 12687426 BACKGROUND

• 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.

  PMID: 17164090 BACKGROUND

• 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.

  PMID: 17000392 BACKGROUND

• 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.

  PMID: 23143146 BACKGROUND

• 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.

  PMID: 21152940 BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Miguel Ángel García-Ureña, Professor

  Henares University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 11, 2013
• Study Start: June 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2013
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

ES (1)