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

Not Applicable

• Conditions: Eventration

• 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.

Study Timeline

• Study Start: 2016-06-27
• Study First Submitted: 2018-04-27
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-09
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 154

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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