NCT03520465

Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Instituto de Investigacion Sanitaria La Fe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eventration

Interventions

Type	Name	Description
DEVICE	DynaMesh®-CICAT longitudinal measure 10x35 cm

Timeline

• Start date: 2016-06-27
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2018-05-09
• Last updated: 2019-08-13

Locations

1 site across 1 country: Spain