Clinical trial NCT01788826: Prophylactic Mesh to Reduce The Incidence of Ventral Hernia
Official title: Randomized Clinical Trial to Evaluate the Use of a Prophylactic Polypropylene Mesh To Reduce the Incidence of Ventral Hernias in Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventral Hernia
Keywords: Ventral hernia
surgical meshes
polypropylenes
Lead sponsor: Henares University Hospital
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 112
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Compare the incidence of ventral hernia between the 2 groups
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of superficial surgical site infection
timeFrame: 30 days
measure: Incidence of deep surgical site infection
timeFrame: 30 days
measure: Seroma
timeFrame: 30 days
measure: Postoperative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Coslada
country: Spain
facility: Henares University Hospital
state: Madrid
Study officials:
affiliation: Henares University Hospital
name: Miguel Ángel García-Ureña, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.