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

Eventration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03520465
• Other study ID #: PEACE
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2016
• Est. completion date: June 2020

Study information

• Verified date: August 2019
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: Laura Segura
• Phone: 0034961246711
• Email: investigacion_clinica[@]iislafe.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Eventration
• Gastroschisis
• Hernia, Umbilical

Intervention

Device:
• DynaMesh®-CICAT longitudinal measure 10x35 cm

Locations

Country	Name	City	State
Spain	Hospital Universitario y Politécnico La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eventration rate	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.	1 year
Secondary	Complications rate	To compare the appearance of complications in the control group and in the experimental group.	1 year
Secondary	Short and long term derived costs	To compare the costs derived from short and long-term mesh placement in both groups.	1 year