Comparison of mesh fixation techniques in open ventral hernia repair
| ISRCTN | ISRCTN95370808 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95370808 |
| Secondary identifying numbers | 36/24-7-20 |
- Submission date
- 08/10/2021
- Registration date
- 09/10/2021
- Last edited
- 23/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Hernia repair is one of the most common surgeries. The use of mesh in hernia repairs is the method of choice in all postoperative hernias and in primary hernias with a gap larger than 2 cm as it significantly lowers the recurrence rates. The mesh can be placed in various positions in the abdominal wall. In this study the goal is to assess the best fixation method for the mesh: sutures or glue. Τhe fixation method may affect pain and quality of life after surgery, as when glue is used theoretically it does not entrap nerves or puncture vessels that could cause hematoma. The aim of this study is to find whether there is a difference between fixation with sutures or with glue in hernia repair.
Who can participate?
Patients with a ventral hernia are eligible to participate as long as it is safe to undergo surgery according to their health problems.
What does the study involve?
Participants are randomly allocated to undergo hernia repair using sutures or glue. Questionnaires are completed before the surgery and 1, 3, 6 and 12 months after to see if there is a difference concerning pain, quality of life and other parameters.
What are the possible benefits and risks of participating?
The two fixation methods are already used and are considered safe by the surgical community. All the data will be collected according to laws and regulations and the identity of the patient will be concealed.
Where is the study run from?
Aristotle University of Thessaloniki
When is the study starting and how long is it expected to run for?
July 2020 to July 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Grigoris Chatzimavroudis
gchatzim@auth.gr
Contact information
Scientific
2nd Surgical Clinic
Aristotle University of Thessaloniki
G. Gennimatas General Hospital
Ethnikis Aminis 41
Thessaloniki
54635
Greece
| Phone | +30 (0)2310434680 |
|---|---|
| gchatzim@auth.gr |
Study information
| Study design | Randomized prospective single-blinded clinical single-center study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomized clinical trial comparing two different mesh fixation techniques in open retromuscular ventral hernia repair |
| Study objectives | There is a difference between mesh fixation in open retromuscular ventral hernia repair using sutures or glue in terms of early or chronic postoperative pain, quality of life, hernia recurrence or other complications, the duration of the surgical procedure and the length of the hospital stay. |
| Ethics approval(s) | 1. Approved 22/12/2020, The Bioethics Committee of the Aristotle University of Thessaloniki (new building of the medical school, 54124, Thessaloniki, Greece; +30 (0)2310999338; bioethics@med.auth.gr), ref: 3328 2. Approved 06/05/2021, the scientific board of the G. Gennimatas General Hospital of Thessaloniki and the 3rd Health District (Ethnikis Aminis 41, 54635, Thessaloniki, Greece and Aristotelous 16, 54623, Thessaloniki, Greece; +30 (0)2313305233; education@3ype.gr), ref: Δ3β/19289 |
| Health condition(s) or problem(s) studied | Retromuscular ventral hernia repair |
| Intervention | Adults with ventral hernias will be included in this study and they will undergo open ventral hernia repair with retromuscular placement of the mesh. The two techniques that will be applied will be either Rives-Stoppa (for gaps with a transverse diameter of up to 5-6 cm), or posterior separation of the abdominal wall elements with the transversus abdominis release technique (TAR) (for gaps with transverse diameter >5-6 cm). In the field of inguinal hernias, studies have shown that the fixation method may have a difference concerning the postoperative pain and quality of life, when glue is used because theoretically it does not entrap nerves, or punctures vessels that could lead to hematoma. The aim of this study is to expand this observation to the retromuscular ventral hernia repair and find out if this difference applies in this case too. The patients will be randomized with a random number table into two groups based on the fixation method of the mesh (group A: suture, group B: glue). The type of sutures that will be used will be PDS and the glue will be cyanoacrylic, which is a biosynthetic material that is not as studied as the fibrin glue for this procedure. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Postoperative pain measured using the visual analogue scale of pain 0-10 at 3 and 6 months |
| Secondary outcome measures | 1. Postoperative pain measured using the visual analogue scale of pain 0-10 at 7, 14, 30 days and 12 months 2. Hernia recurrence measured by clinical examination, CT scan if necessary at 7, 14, 30 days and 12 months 3. Other complications measured by clinical examination, laboratory and radiological tests if necessary at 7, 14, 30 days and 12 months 4. Duration of surgery in minutes, measured after the end of the operation 5. Length of hospital stay in days, measured after the patient’s discharge 6. The amount and the type of analgesic drugs needed at 7, 14, 30 days and 3, 6 and 12 months 7. Quality of life measured using HerQLes and EuraHS QOL preoperatively and at 3, 6 and 12 months. These questionnaires assess the impact of abdominal hernia and surgery on rehabilitation, mental health, daily activities, work, exercise, pain, aesthetic outcome, and sex life. |
| Overall study start date | 24/07/2020 |
| Completion date | 24/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 42 |
| Total final enrolment | 48 |
| Key inclusion criteria | 1. Adults 2. Ventral hernia 3. Eligible for hernia repair |
| Key exclusion criteria | Serious health problems that prevent a safe surgical intervention, for example serious heart or kidney failure |
| Date of first enrolment | 06/05/2021 |
| Date of final enrolment | 24/07/2022 |
Locations
Countries of recruitment
- Greece
Study participating centre
G. Gennimatas General Hospital
Ethnikis Aminis 41
Thessaloniki
54635
Greece
Sponsor information
University/education
Aristotle University of Thessaloniki Campus
Thessaloniki
54124
Greece
| Phone | +30 (0)2310 996000 |
|---|---|
| grammedphd@auth.gr | |
| Website | https://www.auth.gr/ |
"ROR" |
https://ror.org/02j61yw88 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 24/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
23/08/2024: The intention to publish date was changed from 24/07/2024 to 24/11/2024.
27/02/2024: The intention to publish date was changed from 24/02/2024 to 24/07/2024.
11/10/2023: The intention to publish date was changed from 24/10/2023 to 24/02/2024.
14/07/2023: The scientific contact confirmed the overall study end date and the intention to publish date.
25/11/2022: The total final enrollment number was added.
08/10/2021: Trial's existence confirmed by the scientific board of G. Gennimatas General Hospital of Thessaloniki.
