Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery

Federal University of São Paulo

Status: Unknown

Conditions: Seroma

Treatments: Procedure: Abdominoplasty without Scarpa´s Facia; Procedure: abdominoplasty with Scarpa's Fascia

Study type: Interventional

Funder types: Other

Identifiers

NCT01942707

INFORZATO55

Details and patient eligibility

About

46 female postbariatric patients will be submitted to anchor-line abdominoplasty with drains insertion. Patients will be randomized to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.

Full description

Morbid obesity has been increasing in Brazil and the world and bariatric surgery is the most effective and long-lasting treatment. This leads to large weight losses leading to large body deformities due to excess skin and subcutaneous tissue. The most common post-bariatric plastic surgery is post-bariatric abdominoplasty which main complication is seroma. PURPOSE: To evaluate the effect of Scarpa fascia preservation in seroma reduction. METHODS: A total of 46 patients were randomly assigned to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.

Enrollment: 46 patients

Sex: Female

Ages: 24 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI between 22 and 30 Kg/m2
• Female post-bariatric patient

Exclusion criteria

• neoplasms
• Diabetes
• lymphatic system diseases
• abdominal scars except C section and bariatric surgery scars
• mental disorders

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Abdominoplasty without Scarpa´s Facia

Active Comparator group

Description:

Anchor-line abdominoplasty where the Scarpa's Fascia will be removed.

Treatment:

Procedure: Abdominoplasty without Scarpa´s Facia

abdominoplasty with Scarpa's Fascia

Experimental group

Description:

Anchor-line abdominoplasty where the Scarpa's Fascia will be preserved.

Treatment:

Procedure: abdominoplasty with Scarpa's Fascia