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Clinical Trials/NCT03520465
NCT03520465
Unknown
Not Applicable

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

Instituto de Investigacion Sanitaria La Fe1 site in 1 country154 target enrollmentJune 27, 2016
ConditionsEventration

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eventration
Sponsor
Instituto de Investigacion Sanitaria La Fe
Enrollment
154
Locations
1
Primary Endpoint
Eventration rate
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 27, 2016
End Date
June 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Instituto de Investigacion Sanitaria La Fe
Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Complications rate(1 year)
  • Short and long term derived costs(1 year)

Study Sites (1)

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