Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI

Incisional Hernia Clinical Trial

— VISIBLE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03105895
• Other study ID #: HH 02
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 4, 2017
• Last updated: April 8, 2017
• Start date: September 2016
• Est. completion date: September 2020

Study information

• Verified date: April 2017
• Source: Henares University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: September 2020
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Procedure:
• Mesh group
An onlay PDVF mesh will be placed as abdominal wall reinforcement

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Henares University Hospital	CARDIOLINK

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional Hernia	Development of an incisional hernia diagnosed clinically or radiologically	24 months
Secondary	Surgical site infection	Wound infection according to CDC guidelines	30 days
Secondary	Surgical site seroma	Seroma ocurrence in the wound	30 days
Secondary	Surgical site hematoma	Hematoma occurrence in the wound	30 days
Secondary	Mesh exposition	Mesh that can be seen during postoperative recovery without skin covarage	30 days
Secondary	Evisceration	Postoperative wound dehiscence	30 days
Secondary	Systemic complications	Any systemic complication occurred in the postoperative period	30 days
Secondary	Chronic mesh infection	Mesh chronically infected that need removal to solve	up to 2 years postoperative
Secondary	Abdominal wall pain	VAS score in the follow-up	Up to 2 years
Secondary	Length of mesh at MRI 6 weeks	Length of the mesh calculated at the MRI planned at 6 weeks	6 weeks
Secondary	Width of mesh at MRI 6 weeks	Width of the mesh calculated at the MRI planned at 6 weeks	6 weeks
Secondary	Length of mesh at MRI 1 year	Length of the mesh calculated at the MRI planned at 1 year	1 year
Secondary	Width of mesh at MRI 1 year	Width of the mesh calculated at the MRI planned at 1 year	1 year