Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI (VISIBLE)

Multicenter Study on Prevention of Incisional Hernia After Laparotomy With an Onlay Mesh Visible on MRI

It has been demonstrated that incisional hernia incidence after laparotomy can be safely reduced with the addition of a mesh to the conventional closure of the abdominal wall. There still some debate about which is the best position to place this mesh: onlay or sublay. In Europe we have now meshes with CEE approval to be used as reinforcement of abdominal wall closure. The investigators have planned to include 200 patients in a multi center study using an onlay PDVF mesh that can be tracked by magnetic resonance. The patients included will be patients with risk factors for the development of an incisional hernia. The incidence of incisional hernia will be assessed clinically and radiologically after 1 and 2 years follow-up. The incidence of surgical sites occurrences and pain will be also assessed.

Study Overview

• Status: Unknown
• Conditions: Incisional Hernia
• Intervention / Treatment: Procedure: Mesh group

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Puerta de Hierro University Hospital
  • Asturias
    • Aviles, Asturias, Spain
      • San Agustín University Hospital
    • Oviedo, Asturias, Spain
      • University Central Hospital of Asturias
  • Cádiz
    • Puerto Real, Cádiz, Spain
      • Puerto Real University Hospital
  • Madrid
    • Arganda, Madrid, Spain
      • Sureste Hospital
  • Toledo
    • Talavera de la Reina, Toledo, Spain
      • Nuestra Señora del Prado University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing midline laparotomy

Description

Inclusion Criteria: Any known risk factor for development of incisional hernia

• > 60 years
• BMI > 30
• DM
• Chronic bronquitis
• Smoking
• Neoplasia
• Renal failure
• Liver failure
• Immnusupression
• Urgent operation

Exclusion Criteria:

• Previous supraumbilical midline laparotomy
• Previous incisional hernia
• Emergency surgery
• Life expectancy of less than 12 months
• Patient´s rejection to participate
• Unable to understand and participate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incisional Hernia	Development of an incisional hernia diagnosed clinically or radiologically	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection	Wound infection according to CDC guidelines	30 days
Surgical site seroma	Seroma ocurrence in the wound	30 days
Surgical site hematoma	Hematoma occurrence in the wound	30 days
Mesh exposition	Mesh that can be seen during postoperative recovery without skin covarage	30 days
Evisceration	Postoperative wound dehiscence	30 days
Systemic complications	Any systemic complication occurred in the postoperative period	30 days
Chronic mesh infection	Mesh chronically infected that need removal to solve	up to 2 years postoperative
Abdominal wall pain	VAS score in the follow-up	Up to 2 years
Length of mesh at MRI 6 weeks	Length of the mesh calculated at the MRI planned at 6 weeks	6 weeks
Width of mesh at MRI 6 weeks	Width of the mesh calculated at the MRI planned at 6 weeks	6 weeks
Length of mesh at MRI 1 year	Length of the mesh calculated at the MRI planned at 1 year	1 year
Width of mesh at MRI 1 year	Width of the mesh calculated at the MRI planned at 1 year	1 year

Collaborators and Investigators

• Sponsor: Henares University Hospital
• Collaborators: CARDIOLINK

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 8, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Incisional hernia; Mesh prevention; Mesh augmentation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: HH 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This is study to watch the behavior of an onlay mesh for incisional hernia prevention after laparotomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No