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 : August 13, 2019
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|