Clinical trial NCT03105895: Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI
Official title: Multicenter Study on Prevention of Incisional Hernia After Laparotomy With an Onlay Mesh Visible on MRI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Incisional Hernia
Keywords: Incisional hernia
Mesh prevention
Mesh augmentation
Lead sponsor: Henares University Hospital
Sponsor class: OTHER
Collaborators: name: CARDIOLINK
First posted: 2017-04-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing midline laparotomy

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incisional Hernia
timeFrame: 24 months
Secondary outcomes:
measure: Surgical site infection
timeFrame: 30 days
measure: Surgical site seroma
timeFrame: 30 days
measure: Surgical site hematoma
timeFrame: 30 days
measure: Mesh exposition
timeFrame: 30 days
measure: Evisceration
timeFrame: 30 days
measure: Systemic complications
timeFrame: 30 days
measure: Chronic mesh infection
timeFrame: up to 2 years postoperative
measure: Abdominal wall pain
timeFrame: Up to 2 years
measure: Length of mesh at MRI 6 weeks
timeFrame: 6 weeks
measure: Width of mesh at MRI 6 weeks
timeFrame: 6 weeks
measure: Length of mesh at MRI 1 year
timeFrame: 1 year
measure: Width of mesh at MRI 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Aviles
country: Spain
facility: San Agustín University Hospital
state: Asturias
city: Oviedo
country: Spain
facility: University Central Hospital of Asturias
state: Asturias
city: Puerto Real
country: Spain
facility: Puerto Real University Hospital
state: Cádiz
city: Arganda
country: Spain
facility: Sureste Hospital
state: Madrid
city: Talavera de la Reina
country: Spain
facility: Nuestra Señora del Prado University Hospital
state: Toledo
city: Madrid
country: Spain
facility: Puerta de Hierro University Hospital
Study officials:
References: