Clinical trial NCT01942707: Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery
Official title: Study of Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Seroma
Keywords: Abdominoplasty,Seroma,Bariatric surgery
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 46
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Volume of Drainage in ml.
timeFrame: number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days
Secondary outcomes:
measure: Number of Days Required for Drain Withdrawal.
timeFrame: Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days
measure: Volume of Seroma Assessed by Ultrasound of the Abdominal Wall.
timeFrame: Done after 20 days of surgery
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Lydia M Ferreira, MD, Phd
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Juan C Montano-Pedroso, PhD
role: STUDY_CHAIR
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