Abdominoplasty and incisional hernia repair
| ISRCTN | ISRCTN14892408 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14892408 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/01/2015
- Registration date
- 09/02/2015
- Last edited
- 18/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Abdominoplasty (surgical removal of excess fat or skin) is one of the most popular cosmetic surgeries performed by surgeons throughout the world. The continuing advances in this area can help improve outcomes. The combination of abdominoplasty and hernia repair is expected to further improve outcomes, but may have a negative impact on outcomes. The aim in this study is to find out whether abdominoplasty at the time of hernia repair modifies the incidence of complications and recurrence.
Who can participate?
Women who are overweight and have hernia
What does the study involve?
Participants will be randomly allocated to hernia repair alone or abdominoplasty and hernia repair.
What are the possible benefits and risks of participating?
The possible benefits are less infection, better healing and improved patient satisfaction. A possible risk is a negative effect on the outcome measures.
Where is the study run from?
Morales Meseguer University Hospital (Spain)
When is the study starting and how long is it expected to run for?
From January 2012 to December 2014
Who is funding the study?
University of Medicine (Spain)
Who is the main contact?
Professor Alfredo Moreno-Egea
moreno-egea@ono.com
Contact information
Scientific
Primo de Rivera 7
5ºD
Murcia
30008
Spain
 ORCID ID |
0000-0002-5473-7062 |
|---|---|
| Phone | +34 639662113 |
| moreno-egea@ono.com |
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| 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 the contact details below to request a patient information sheet. |
| Scientific title | Effect of abdominoplasty and incisional hernia repair on morbidity: a randomised controlled trial |
| Study acronym | AP-IHR |
| Study objectives | Does the combination of abdominoplasty and hernia repair modify morbidity? |
| Ethics approval(s) | Ethics Committee of the University Morales Meseguer Hospital (Spain), 12/01/2012 |
| Health condition(s) or problem(s) studied | Abdominoplasty with concurrent hernia repair |
| Intervention | 1. Hernia repair 2. Abdominoplasty and hernia repair |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Surgical-site infection 2. Wound disruption 3. Seroma 4. Haematoma 5. Time of surgery 6. Hospital stay These outcomes will be assessed at 1 month, 3 months, 6 months, 12 months and 24 months. |
| Secondary outcome measures | General complications (pulmonary embolism, pneumonia or sepsis); these will be assessed at 1 month, 3 months, 6 months, 12 months and 24 months. |
| Overall study start date | 01/01/2012 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Hernia repair (n=20) and abdominoplasty and hernia repair (n=20) |
| Key inclusion criteria | 1. Ventral hernia 2. Obesity 3. Age 40–85 years 4. American Society of Anesthesiologists Physical Status classification controlled |
| Key exclusion criteria | 1. Age < 40 years 2. Strangulated hernia 3. Malignant diseases 4. Mental illness 5. Circumstances that might compromise the patient’s cooperation 6. Refusal to give informed consent |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 30/12/2014 |
Locations
Countries of recruitment
- Spain
Study participating centre
30008
Spain
Sponsor information
Hospital/treatment centre
5 Avda Teniente Flomesta
Murcia
30003
Spain
| Phone | +34 868 88 3000 |
|---|---|
| moreno-egea@ono.com | |
| Website | www.universidaddemurcia.es |
"ROR" |
https://ror.org/03p3aeb86 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/06/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | June 2015 |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 28/04/2016 | 18/02/2022 | Yes | No |
Editorial Notes
18/02/2022: Publication reference added.
