Condition category
Digestive System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

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

Contact information



Primary contact

Mr Mikael Lindmark


Contact details

University Hospital of Umeå (Norrlands Universitetssjukhus)
901 85

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Prospective RandOmised Study of Endoscopic fascia Closure and long term Outcome



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Please use contact details to request a participant information sheet


Ventral hernia


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


Participant exclusion criteria

1. Recurrence after previous hernia surgery
2. Laparoscopy not feasible

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Skellefteå Hospital (Skellefteå lasarett)
931 41 Skellefteå

Trial participating centre

Mora hospital (Mora lasarett)
792 51 Mora

Trial participating centre

Ersta hospital
116 28

Trial participating centre

Enköping hospital
745 38

Sponsor information


Västerbotten County Council

Sponsor details

Köksvägen 11
901 85

Sponsor type




Funder type


Funder name

Visare Norr (cooperation northern counties)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Västerbotten Läns Landsting

Alternative name(s)

Västerbotten County Council

Funding Body Type

government organisation

Funding Body Subtype

Local government



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


Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/08/2020: The recruitment end date has been changed from 01/05/2020 to 15/10/2020. 24/08/2020: Recruitment for this study is no longer paused. 28/05/2020: Due to current public health guidance, recruitment for this study has been paused. 20/01/2020: IPD sharing statement added. 17/01/2020: The following changes were made to the trial record: 1. The recruitment end date was changed from 20/12/2019 to 01/05/2020. 2. The overall trial end date was changed from 20/12/2020 to 01/05/2021. 3. The intention to publish date was changed from 31/01/2021 to 31/01/2022. 18/10/2019: The intention to publish date has been changed from 08/04/2019 to 31/01/2021. 03/10/2019: The following changes were made to the trial record: 1. The overall end date was changed from 08/04/2018 to 20/12/2020. 2. The recruitment end date was changed from 08/04/2017 to 20/12/2019. 3. The trial participating centre "Sunderby hospital" was removed, "Ersta hospital" and "Enköping Hospital" were added.