Prophylactic Mesh to Reduce The Incidence of Ventral Hernia
- Conditions
- Ventral Hernia
- Interventions
- Procedure: Prophylactic meshProcedure: No prophylactic mesh closure
- Registration Number
- NCT01788826
- Lead Sponsor
- Henares University Hospital
- 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 Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 112
- 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
- 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- Withdrawn or missing written consent.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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prophylactic Mesh Prophylactic mesh Use of a prefascial polypropylene mesh when closing midline laparotomy No prophylactic mesh closure No prophylactic mesh closure In this arm the laparotomy of the patients are closed with a running absorbable suture without a mesh
- Primary Outcome Measures
Name Time Method Compare the incidence of ventral hernia between the 2 groups 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
- Secondary Outcome Measures
Name Time Method Incidence of superficial surgical site infection 30 days Compare the incidence of superficial surgical site infection between the 2 groups
Incidence of deep surgical site infection 30 days Compare the incidence of deep surgical site infection between the 2 groups
Seroma 30 days Incidence of postoperative seroma
Postoperative complications 30 days Register of postoperative complications, including pulmonary, fistula and postoperative ileum
Trial Locations
- Locations (1)
Henares University Hospital
🇪🇸Coslada, Madrid, Spain