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

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.

Study Overview

• Status: Unknown
• Conditions: Eventration
• Intervention / Treatment: Device: DynaMesh®-CICAT longitudinal measure 10x35 cm

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 Type: Interventional
• Enrollment (Anticipated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Segura; Phone Number: 0034961246711; Email: investigacion_clinica@iislafe.es

Study Locations

• Spain
  • Valencia, Spain
    • Recruiting
    • Hospital Universitario y Politécnico La Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications rate	To compare the appearance of complications in the control group and in the experimental group.	1 year
Short and long term derived costs	To compare the costs derived from short and long-term mesh placement in both groups.	1 year

Collaborators and Investigators

• Sponsor: Instituto de Investigacion Sanitaria La Fe
• Investigators: Principal Investigator: Matteo Frasson, Instituto de Investigación Sanitaria La Fe

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 27, 2016
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: April 27, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (ACTUAL): May 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Infant, Newborn, Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Musculoskeletal Abnormalities; Hernia; Hernia, Ventral; Hernia, Umbilical; Gastroschisis
• Other Study ID Numbers: PEACE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO