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

• Sponsor: Henares University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03105895
• Collaborator: CARDIOLINK (Other)
• Enrollment: 200
• Locations: 6
• Anticipated Duration (Months): 48
• Patients Per Site: 33.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Incisional Hernia	Procedure: Mesh group

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multicenter Study on Prevention of Incisional Hernia After Laparotomy With an Onlay Mesh Visible on MRI
• Actual Study Start Date: Sep 1, 2016
• Anticipated Primary Completion Date: Sep 1, 2018
• Anticipated Study Completion Date: Sep 1, 2020

Outcome Measures

Primary Outcome Measures

1. Incisional Hernia [24 months]

   Development of an incisional hernia diagnosed clinically or radiologically

Secondary Outcome Measures

1. Surgical site infection [30 days]

   Wound infection according to CDC guidelines

2. Surgical site seroma [30 days]

   Seroma ocurrence in the wound

3. Surgical site hematoma [30 days]

   Hematoma occurrence in the wound

4. Mesh exposition [30 days]

   Mesh that can be seen during postoperative recovery without skin covarage

5. Evisceration [30 days]

   Postoperative wound dehiscence

6. Systemic complications [30 days]

   Any systemic complication occurred in the postoperative period

7. Chronic mesh infection [up to 2 years postoperative]

   Mesh chronically infected that need removal to solve

8. Abdominal wall pain [Up to 2 years]

   VAS score in the follow-up

9. Length of mesh at MRI 6 weeks [6 weeks]

   Length of the mesh calculated at the MRI planned at 6 weeks

10. Width of mesh at MRI 6 weeks [6 weeks]

    Width of the mesh calculated at the MRI planned at 6 weeks

11. Length of mesh at MRI 1 year [1 year]

    Length of the mesh calculated at the MRI planned at 1 year

12. Width of mesh at MRI 1 year [1 year]

    Width of the mesh calculated at the MRI planned at 1 year

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Agustín University Hospital	Aviles	Asturias	Spain
2	University Central Hospital of Asturias	Oviedo	Asturias	Spain
3	Puerto Real University Hospital	Puerto Real	Cádiz	Spain
4	Sureste Hospital	Arganda	Madrid	Spain
5	Nuestra Señora del Prado University Hospital	Talavera de la Reina	Toledo	Spain
6	Puerta de Hierro University Hospital	Madrid		Spain

Sponsors and Collaborators

• Henares University Hospital
• CARDIOLINK

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Miguel A ngel Garci-a Urena, Professor of Surgery, Henares University Hospital
• ClinicalTrials.gov Identifier: NCT03105895
• Other Study ID Numbers: HH 02
• First Posted: Apr 10, 2017
• Last Update Posted: Apr 11, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Miguel A ngel Garci-a Urena, Professor of Surgery, Henares University Hospital: Incisional hernia; Mesh prevention; Mesh augmentation
• Additional relevant MeSH terms: Hernia; Incisional Hernia

Study Results

No Results Posted as of Apr 11, 2017