Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection
- Conditions
- Eventration
- Interventions
- Device: DynaMesh®-CICAT longitudinal measure 10x35 cm
- Registration Number
- NCT03520465
- Lead Sponsor
- Instituto de Investigacion Sanitaria La Fe
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 154
- Elective surgery for colorectal cancer.
- Surgery by middle laparotomy.
- Informed consent signed by the patient.
- Age > 18 years.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supraaponeurotic mesh DynaMesh®-CICAT longitudinal measure 10x35 cm Patients with laparotomy closure by conventional approach of aponeurosis (continuous suture with monofilament of slow absorption), and posterior placement of supraaponeurotic mesh of polyvinylidene fluoride (PVDF) medium / low density and wide pore. The mesh has a longitudinal measurement that exceeds about 3 cm the upper and lower ends of the wound and width should not be less than 10 cm, therefore the mesh selected is DynaMesh®-CICAT longitudinal measure 10x35 cm. The mesh is fixed to the aponeurosis with a crown of loose stitches and points to the midline. A prolene 2/0 non-reabsorbable monofilament suture of cylindrical needle is used. A 10 Fr suction drainage is placed in the supraaponeurotic plane, with an exit to the exterior beyond the edges of the prosthesis. Drainage will be preserved for a minimum of 48 hours after surgery, and will be withdrawn when a debit of less than 50 ml is presented in 24 h.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Hospital Universitario y Politécnico La Fe
🇪🇸Valencia, Spain