Closing of the hernia defect during laparoscopic ventral hernia repair
| ISRCTN | ISRCTN51495042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51495042 |
| Secondary identifying numbers | ML2 |
- Submission date
- 15/02/2016
- Registration date
- 22/04/2016
- Last edited
- 03/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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 November 2021
Who is funding the study?
1. Västerbotten County Council
2. Visare Norr (cooperation northern counties)
Who is the main contact?
Mr Mikael Lindmark
Contact information
Scientific
University Hospital of Umeå (Norrlands Universitetssjukhus)
Umeå
901 85
Sweden
Study information
| Study design | Double-blinded randomized controlled multicenter trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Please use contact details to request a participant information sheet |
| Scientific title | Prospective RandOmised Study of Endoscopic fascia Closure and long term Outcome |
| Study acronym | PROSECO |
| Study objectives | 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(s) | Regional ethics board Umeå (SE), 18/06/2015, ref: 2015-215-32M |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 08/04/2015 |
| Completion date | 01/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 180 |
| Total final enrolment | 192 |
| Key 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 |
| Key exclusion criteria | 1. Recurrence after previous hernia surgery 2. Laparoscopy not feasible |
| Date of first enrolment | 18/11/2015 |
| Date of final enrolment | 16/09/2020 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Sweden
Sweden
116 28
Sweden
745 38
Sweden
Sponsor information
University/education
Landstingshuset
Köksvägen 11
Umeå
901 85
Sweden
"ROR" |
https://ror.org/04xvhsp09 |
|---|
Funders
Funder type
Government
No information available
Government organisation / Local government
- Alternative name(s)
- Västerbotten County Council
- Location
- Sweden
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/12/2023 | 03/01/2024 | Yes | No |
Editorial Notes
03/01/2024: Publication reference added.
13/12/2022: The intention to publish date was changed from 01/04/2023 to 30/06/2023.
15/11/2022: The intention to publish date has been changed from 30/11/2022 to 01/04/2023.
21/04/2022: The intention to publish date has been changed from 30/04/2022 to 30/11/2022.
18/05/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/05/2021 to 01/11/2021.
2. The intention to publish date was changed from 31/01/2022 to 30/04/2022.
16/10/2020: The following changes have been made:
1. The recruitment end date has been changed from 15/10/2020 to 16/09/2020.
2. The total final enrolment number has been added.
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.
