Condition category
Digestive System
Date applied
28/01/2015
Date assigned
09/02/2015
Last edited
09/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

www.universidaddemurcia.es

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

Publication citations

Additional files

Editorial Notes