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
moreno-egea@ono.com
Trial website
Contact information
Type
Scientific
Primary contact
Professor Alfredo Moreno-Egea
ORCID ID
http://orcid.org/0000-0002-5473-7062
Contact details
Primo de Rivera 7
5ºD
Murcia
30008
Spain
+34 639662113
moreno-egea@ono.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of abdominoplasty and incisional hernia repair on morbidity: a randomised controlled trial
Acronym
AP-IHR
Study hypothesis
Does the combination of abdominoplasty and hernia repair modify morbidity?
Ethics approval
Ethics Committee of the University Morales Meseguer Hospital (Spain), 12/01/2012
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Abdominoplasty with concurrent hernia repair
Intervention
1. Hernia repair
2. Abdominoplasty and hernia repair
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
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 trial start date
01/01/2012
Overall trial end date
31/12/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Ventral hernia
2. Obesity
3. Age 40–85 years
4. American Society of Anesthesiologists Physical Status classification controlled
Participant type
Patient
Age group
Adult
Gender
Female
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
01/01/2012
Recruitment end date
30/12/2014
Locations
Countries of recruitment
Spain
Trial participating centre
Morales Meseguer University Hospital
Murcia
30008
Spain
Sponsor information
Organisation
University of Medicine
Sponsor details
5 Avda Teniente Flomesta
Murcia
30003
Spain
+34 868 88 3000
moreno-egea@ono.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
University of Medicine (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
June 2015
Intention to publish date
30/06/2015
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary