Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection
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|ClinicalTrials.gov Identifier: NCT03520465|
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Eventration||Device: DynaMesh®-CICAT longitudinal measure 10x35 cm||Not Applicable|
Randomized prospective experimental study, in which we evaluate patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy in order to:
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Double blind, for the patient and the radiologist who analyses the results of the imaging tests.|
|Official Title:||Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection|
|Actual Study Start Date :||June 27, 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Supraaponeurotic mesh
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.
Device: DynaMesh®-CICAT longitudinal measure 10x35 cm
No Intervention: Monofilament
Patients with conventional closure of the middle laparotomy with approach of aponeurosis in a plane by continuous suture with monofilament of slow absorption. In this study, the suture used in all patients will be poly-4-hydroxybutyrate or Mono-max loop®.
- Eventration rate [ Time Frame: 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.
- Complications rate [ Time Frame: 1 year ]To compare the appearance of complications in the control group and in the experimental group.
- Short and long term derived costs [ Time Frame: 1 year ]To compare the costs derived from short and long-term mesh placement in both groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520465
|Contact: Laura Seguraemail@example.com|
|Hospital Universitario y Politécnico La Fe||Recruiting|
|Contact: Laura Segura|
|Principal Investigator:||Matteo Frasson||Instituto de Investigación Sanitaria La Fe|