Plain English Summary
Background and study aims
A ventral hernia is a bulge of tissues through an opening (or defect) within the abdominal wall muscles. They can sometimes cause symptoms such as pain in the abdomen, outward bulging of skin or tissues, nausea and vomiting. This study is comparing two different ways of performing laparoscopic (keyhole) ventral hernia repair. The aim is to test the effect of closing the defect with a suture (stitches) before reinforcement using a mesh.
Who can participate?
Adults (over 18) with a ventral hernia which has not previously been repaired with a mesh.
What does the study involve?
Participants are randomly assigned to one of two groups. Group 1 has a laparoscopic ventral hernia repair with the defect sutured before using the mesh. Participants in group 2 have their mesh applied without closing of the defect with a suture. All participants are then assessed at 3 months and then again at 12 months for complications. They also have a CT scan at 12 months. Tissue samples (biopsies) are also taken from the skin, muscle Biopsy from skin, muscle and fascia (connective tissue) are taken and analysed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Skellefteå hospital
Mora hospital
Ersta hospital
Enköping hospital (Sweden)
When is the study starting and how long is it expected to run for?
April 2015 to May 2021
Who is funding the study?
1. Västerbotten County Council
2. Visare Norr (cooperation northern counties)
Who is the main contact?
Mr Mikael Lindmark
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ML2
Study information
Scientific title
Prospective RandOmised Study of Endoscopic fascia Closure and long term Outcome
Acronym
PROSECO
Study hypothesis
Suture of hernia defect before application of mesh prothesis for laparoscopic ventral hernia repair improves the surgical outcome measured as "hernia site complications" (see primary outcome measures below).
Ethics approval
Regional ethics board Umeå (SE), 18/06/2015, ref: 2015-215-32M
Study design
Double blinded randomised controlled multicenter trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Please use contact details to request a participant information sheet
Condition
Ventral hernia
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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.
Secondary outcome measures
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
Overall trial start date
08/04/2015
Overall trial end date
01/05/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
180
Participant exclusion criteria
1. Recurrence after previous hernia surgery
2. Laparoscopy not feasible
Recruitment start date
18/11/2015
Recruitment end date
15/10/2020
Locations
Countries of recruitment
Sweden
Trial participating centre
Skellefteå Hospital (Skellefteå lasarett)
931 41 Skellefteå
Sweden
Trial participating centre
Mora hospital (Mora lasarett)
792 51 Mora
Sweden
Trial participating centre
Ersta hospital
Stockholm
116 28
Sweden
Trial participating centre
Enköping hospital
Enköping
745 38
Sweden
Funders
Funder type
Government
Funder name
Visare Norr (cooperation northern counties)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Västerbotten Läns Landsting
Alternative name(s)
Västerbotten County Council
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Sweden
Results and Publications
Publication and dissemination plan
IPD sharing statement
The dataset includes information making it possible to identify unique individuals, therefore in relation to their ethical statement and Swedish law the researchers have to handle it confidentially.
Intention to publish date
31/01/2022
Participant level data
Not expected to be available
Basic results (scientific)
Publication list