Clinical Trial: Prophylactic Mesh to Reduce The Incidence of Ventral Hernia

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Henares University Hospital

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Henares University Hospital

Dates:
Date Received: February 7, 2013
Date Started: June 2009
Date Completion: September 2013
Last Updated: February 8, 2013
Last Verified: February 2013