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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Seroma

Intervention / Treatment
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* Procedure: abdominoplasty with Scarpa's Fascia
* Procedure: Abdominoplasty without Scarpa´s Facia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Abdominoplasty without Scarpa´s Facia<br>Anchor-line abdominoplasty where the Scarpa's Fascia will be removed. | Procedure: Abdominoplasty without Scarpa´s Facia<br>* During surgical detachment of the abdominal flap the Scarpa´s fascia is removed.<br>|
| Experimental: abdominoplasty with Scarpa's Fascia<br>Anchor-line abdominoplasty where the Scarpa's Fascia will be preserved. | Procedure: abdominoplasty with Scarpa's Fascia<br>* During surgical detachment of the abdominal flap the Scarpa´s fascia is preserved.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Volume of Drainage in ml. | 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. | number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days Required for Drain Withdrawal. | 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. | Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days | 
| Volume of Seroma Assessed by Ultrasound of the Abdominal Wall. | An ultrasound of the abdominal wall will be realized to check the volume of any residual seroma. | Done after 20 days of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominoplasty,Seroma,Bariatric surgery