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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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15 January 2024 |
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Main ID: |
ISRCTN51495042 |
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Date of registration:
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22/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Closing of the hernia defect during laparoscopic ventral hernia repair
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Scientific title:
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Prospective RandOmised Study of Endoscopic fascia Closure and long term Outcome |
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Date of first enrolment:
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18/11/2015 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN51495042 |
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Study type:
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Interventional |
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Study design:
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Double-blinded randomized controlled multicenter trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Mikael
Lindmark |
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Address:
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University Hospital of Umeå (Norrlands Universitetssjukhus)
901 85
Umeå
Sweden |
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Telephone:
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Email:
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Age >18 years
2. Understand written information in Swedish
3. Primary or incisional hernia of the midline between 2 and 8 cm
Exclusion criteria:
1. Recurrence after previous hernia surgery
2. Laparoscopy not feasible
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ventral hernia
Digestive System
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Intervention(s)
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The classic approach in laparoscopic ventral hernia repair is to bridge the hernia defect by reinforcement material. In open techniques, a long- established principle is to, when possible, recreate the anatomy during surgery by suturing of the defect. There is an emerging interest in closing the defect in laparoscopic surgery for ventral hernias before the prosthetic material is applied.
Participants are randomly assigned to one of two groups. They all have a laparoscopic ventral hernia repair, but with the following differences:
Group 1: Undergo suture of hernia defect before application of mesh
Group 2. Mesh is applied without closing of the defect
All participants are then assessed for hernia site complications that occur within 12 months including seroma, hematoma, bulging, mesh migration and infection.
All participants are then assessed for hernia site complications at clinical control after 3 and 12 months. All participants undergo CT scan at 12 months. Hernia site complications include seroma, hematoma, bulging, mesh migration and infection. Biopsy from skin, muscle and fascia are taken and collagen structure will analysed.
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Primary Outcome(s)
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Hernia site complications within twelve months. This includes recurrence of the hernia, sustained clinically significant seroma, and clinically significant and symptomatic pseudo hernia with sliding of the reinforcing material into the aneurysm sac after twelve months.
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Secondary Outcome(s)
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1. Abdominal wall pain, assessed using the Ventral Hernia Pain Questionnaire, before surgery, 3 months after surgery and after 12 months
2. Surgical complications within three months of such as infection, and fistula
3. Operating time
4. Abdominal function measured by Biodex after 12 months
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Source(s) of Monetary Support
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Visare Norr (cooperation northern counties), Västerbotten Läns Landsting
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; Regional ethics board Umeå (SE), 18/06/2015, ref: 2015-215-32M
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/11/2021 |
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URL:
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