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

Not Applicable
Conditions
Seroma
Interventions
Procedure: Abdominoplasty without Scarpa´s Facia
Procedure: abdominoplasty with Scarpa's Fascia
Registration Number
NCT01942707
Lead Sponsor
Federal University of São Paulo
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
46
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Abdominoplasty without Scarpa´s FaciaAbdominoplasty without Scarpa´s FaciaAnchor-line abdominoplasty where the Scarpa's Fascia will be removed.
abdominoplasty with Scarpa's Fasciaabdominoplasty with Scarpa's FasciaAnchor-line abdominoplasty where the Scarpa's Fascia will be preserved.
Primary Outcome Measures
NameTimeMethod
Total Volume of Drainage in ml.number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days

We will measure the total volume of drainage, in ml, obtained by the drains in the abdominal region. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours. Total volume of drainage will be calculated as the sum of the volumes obtained daily.

Secondary Outcome Measures
NameTimeMethod
Number of Days Required for Drain Withdrawal.Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days

Number of days required for drain withdrawal. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours.

Volume of Seroma Assessed by Ultrasound of the Abdominal Wall.Done after 20 days of surgery

An ultrasound of the abdominal wall will be realized to check the volume of any residual seroma.

Trial Locations

Locations (1)

Federal University of São Paulo

🇧🇷

São Paulo, SP, Brazil

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