NCT01788826

Prophylactic Mesh to Reduce The Incidence of Ventral Hernia

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Henares University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-09-01
• Completion: 2013-09-01
• First posted: 2013-02-11
• Last updated: 2013-02-11

Locations

1 site across 1 country: Spain