Prophylactic Mesh to Reduce The Incidence of Ventral Hernia

Study Overview
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Brief Summary
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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.

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

Conditions
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Ventral Hernia

Intervention / Treatment
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* Procedure: Prophylactic mesh
* Procedure: No prophylactic mesh closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic Mesh<br>Use of a prefascial polypropylene mesh when closing midline laparotomy | Procedure: Prophylactic mesh<br>* 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.<br>|
| Experimental: No prophylactic mesh closure<br>In this arm the laparotomy of the patients are closed with a running absorbable suture without a mesh | Procedure: No prophylactic mesh closure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of superficial surgical site infection | Compare the incidence of superficial surgical site infection between the 2 groups | 30 days | 
| Incidence of deep surgical site infection | Compare the incidence of deep surgical site infection between the 2 groups | 30 days | 
| Seroma | Incidence of postoperative seroma | 30 days | 
| Postoperative complications | Register of postoperative complications, including pulmonary, fistula and postoperative ileum | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventral hernia, surgical meshes, polypropylenes