Eventration
Conditions
Brief summary
Randomized prospective experimental study, in which the effect of a prophylactic mesh is assessed in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy, considering as treatment the supra-aponeurotic mesh positioning (experimental group), and comparing it to the standard closing with a continuous suture using slow absorption monofilament.
Detailed description
Randomized prospective experimental study, in which we evaluate patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy in order to: Main objective: \- To assess the effect of the prophylactic mesh in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy. Secondary objectives: * To compare the appearance of complications in the control group and in the experimental group. * Compare costs derived from short and long-term mesh placement in both groups. We consider as treatment the supra-aponeurotic mesh positioning (experimental group), and compare it to the standard closing with slow absorption monofilament.
Interventions
DEVICEDynaMesh®-CICAT longitudinal measure 10x35 cm
Sponsors
Instituto de Investigacion Sanitaria La Fe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double blind, for the patient and the radiologist who analyses the results of the imaging tests.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective surgery for colorectal cancer. * Surgery by middle laparotomy. * Informed consent signed by the patient. * Age \> 18 years.
Exclusion criteria
* Midline hernia or eventration. * Presence of mesh in the abdominal wall because of a previous surgery. * Palliative surgery. * Synchronous metastases (Stage IV cancer according to TNM).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eventration rate | 1 year | To assess the effect of the prophylactic mesh in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications rate | 1 year | To compare the appearance of complications in the control group and in the experimental group. |
| Short and long term derived costs | 1 year | To compare the costs derived from short and long-term mesh placement in both groups. |
Countries
Spain
Contacts
Primary ContactLaura Segura
Outcome results
None listed