Prophylactic Mesh to Reduce The Incidence of Ventral Hernia

Ventral Hernia Clinical Trial

Official title:

Randomized Clinical Trial to Evaluate the Use of a Prophylactic Polypropylene Mesh To Reduce the Incidence of Ventral Hernias in Colorectal Surgery

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01788826
• Other study ID #: HH01
• Status: Unknown status
• Phase: N/A
• First received: February 7, 2013
• Last updated: February 8, 2013
• Start date: June 2009
• Est. completion date: September 2013

Study information

• Verified date: February 2013
• Source: Henares University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 112
• Est. completion date: September 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Henares University Hospital	Coslada	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Henares University Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Bellón JM, López-Hervás P, Rodríguez M, García-Honduvilla N, Pascual G, Buján J. Midline abdominal wall closure: a new prophylactic mesh concept. J Am Coll Surg. 2006 Oct;203(4):490-7. Epub 2006 Aug 23. — View Citation

Díaz-Godoy A, García-Ureña MA, López-Monclús J, Vega Ruíz 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. — View Citation

Gutiérrez de la Peña C, Medina Achirica C, Domínguez-Adame E, Medina Díez J. Primary closure of laparotomies with high risk of incisional hernia using prosthetic material: analysis of usefulness. Hernia. 2003 Sep;7(3):134-6. Epub 2003 Apr 3. — View 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. Review. — View 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. Epub 2006 Dec 11. — View Citation

Stringer RA, Salameh JR. Mesh herniorrhaphy during elective colorectal surgery. Hernia. 2005 Mar;9(1):26-8. Epub 2004 Sep 10. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of superficial surgical site infection	Compare the incidence of superficial surgical site infection between the 2 groups	30 days
Secondary	Incidence of deep surgical site infection	Compare the incidence of deep surgical site infection between the 2 groups	30 days
Secondary	Seroma	Incidence of postoperative seroma	30 days
Secondary	Postoperative complications	Register of postoperative complications, including pulmonary, fistula and postoperative ileum	30 days