Condition category
Digestive System
Date applied
15/02/2016
Date assigned
22/04/2016
Last edited
25/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.norrlandskirurgi.se/Randomisera/

Contact information

Type

Scientific

Primary contact

Mr Mikael Lindmark

ORCID ID

Contact details

University Hospital of Umeå (Norrlands Universitetssjukhus)
Umeå
901 85
Sweden

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

Sponsor information

Organisation

Västerbotten County Council

Sponsor details

Landstingshuset
Köksvägen 11
Umeå
901 85
Sweden

Sponsor type

University/education

Website

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

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.