Abdominoplasty and incisional hernia repair

• Register: ISRCTN
• Last refreshed on: 1 March 2022
• Main ID: ISRCTN14892408
• Date of registration: 09/02/2015
• Prospective Registration: No
• Primary sponsor: University of Medicine
• Public title: Abdominoplasty and incisional hernia repair
• Scientific title: Effect of abdominoplasty and incisional hernia repair on morbidity: a randomised controlled trial
• Date of first enrolment: 01/01/2012
• Target sample size: 40
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN14892408
• Study type: Interventional
• Study design: Single-centre randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Spain

Contacts

• Name: Alfredo Moreno-Egea

Key inclusion & exclusion criteria

Inclusion criteria:
1. Ventral hernia
2. Obesity
3. Age 40–85 years
4. American Society of Anesthesiologists Physical Status classification controlled

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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Abdominoplasty with concurrent hernia repair
Digestive System
Hernia

Intervention(s)

1. Hernia repair
2. Abdominoplasty and hernia repair

Primary Outcome(s)

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(s)

General complications (pulmonary embolism, pneumonia or sepsis); these will be assessed at 1 month, 3 months, 6 months, 12 months and 24 months.

Secondary ID(s)

N/A

Source(s) of Monetary Support

University of Medicine (Spain)

Ethics review

Status:
Approval date:
Contact:

Ethics Committee of the University Morales Meseguer Hospital (Spain), 12/01/2012

Results

• Results available: Yes
• Date Completed: 31/12/2014