Plain English Summary
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
Effect of abdominoplasty and incisional hernia repair on morbidity: a randomised controlled trial
Does the combination of abdominoplasty and hernia repair modify morbidity?
Ethics Committee of the University Morales Meseguer Hospital (Spain), 12/01/2012
Single-centre randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Abdominoplasty with concurrent hernia repair
1. Hernia repair
2. Abdominoplasty and hernia repair
Primary outcome measure
1. Surgical-site infection
2. Wound disruption
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 trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Ventral hernia
3. Age 40–85 years
4. American Society of Anesthesiologists Physical Status classification controlled
Target number of participants
Hernia repair (n=20) and abdominoplasty and hernia repair (n=20)
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Morales Meseguer University Hospital
University of Medicine (Spain)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)