Understanding belly button hernia repair: long-term results and possible complications
| ISRCTN | ISRCTN28583690 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28583690 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Lithuanian hernia society |
| Funder | Lietuvos Sveikatos Mokslų Universitetas |
- Submission date
- 28/12/2023
- Registration date
- 24/01/2024
- Last edited
- 17/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Diastasis recti (separation of the muscles along the midline of the abdomen) is a very common condition that can occur in female and male patients, causing functional and appearance-related issues. It happens in 30-70% of people and is sometimes linked with belly button hernias. Lately, doctors have been using a less invasive method involving a mesh repair technique combined with fixing the muscle separation, and it's becoming quite common.
Who can participate?
Patients aged 18 - 70 years, who underwent elective surgery for small and medium size primary umbilical hernia with diastasis recti.
What does the study involve?
We conducted a careful study on people who chose to have surgery for small (< 2 cm) and medium-sized (2-4 cm) umbilical hernias along with muscle separation. We followed them closely for 12 months after the surgery. To check if the hernia came back or if there were fluid collections afterward, we used physical exams and ultrasound. We also measured how much pain they felt using a scale called Visual Analogue Scale (VAS) and looked at their overall comfort and well-being using a questionnaire called Carolinas Comfort Scale (CCS). Additionally, we investigated factors that might independently increase the risk of fluid collections.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Lithuanian hernia society (Lithuania)
When is the study starting and how long is it expected to run for?
September 2020 to December 2022
Who is funding the study?
Lietuvos Sveikatos Mokslų Universitetas (Lithuania)
Who is the main contact?
Linas Venclauskas, linasvenclauskasg@yahoo.com
Matas Pazusis, ppazusis@gmail.com
Contact information
Public, Scientific, Principal investigator
Eivenių g. 2
Kaunas
50161
Lithuania
| Phone | +370 69881208 |
|---|---|
| linasvenclauskasg@yahoo.com |
Principal investigator
Eivenių g. 2
Kaunas
50161
Lithuania
 ORCID ID |
0000-0003-1324-594X |
|---|---|
| Phone | +370 61821111 |
| ppazusis@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Obserevational prospective cohort |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | The risk factors of seromas and long-term results after umbilical hernia with diastasis recti repair using endoscopic subcutaneous approach (SCOLA) |
| Study objectives | SCOLA procedure is a safe and effective technique for the patients with umbilical hernia and diastasis recti, which gives an acceptable cosmetic results and good quality of life. |
| Ethics approval(s) |
Approved 15/09/2020, The Bioethics Centre of the Lithuanian University of Health Sciences (LSMU) (A. Mickeviciaus g. 9, LT-44307 Kaunas, Kaunas, 44307, Lithuania; + 370 37 327 201; bec@lsmu.lt), ref: BEC-MF-04 |
| Health condition(s) or problem(s) studied | Diastasis recti, umbilical hernia |
| Intervention | A prospective cohort study of patients who underwent elective surgery for small and medium size primary umbilical hernia with diastasis recti was performed. The institutional review board’s permission no. BEC-MF-04 was obtained prior to this study. All the patients were examined in the outpatient department 1, 3, 6 and 12 months after surgery. Patient records were used to gather data. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
All the patients were examined in the outpatient department 1, 3, 6 and 12 months after surgery: |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Patients who underwent elective surgery for small and medium size primary umbilical hernia with diastasis recti was performed. 2. Age 18-70 years old. 3. With no other diseases. |
| Key exclusion criteria | Patiens who had cardiovascular, pulmonary, oncological diseases. |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- Lithuania
Study participating centre
Kaunas
50161
Lithuania
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 31/07/2024 | 17/12/2024 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/12/2024: Publication reference added.
08/01/2024: Trial's existence confirmed by The Bioethics Centre of the Lithuanian University of Health Sciences (LSMU).
