Seroma
Conditions
Keywords
Abdominoplasty,Seroma,Bariatric surgery
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.
Interventions
PROCEDUREabdominoplasty with Scarpa's Fascia
During surgical detachment of the abdominal flap the Scarpa´s fascia is preserved.
PROCEDUREAbdominoplasty without Scarpa´s Facia
During surgical detachment of the abdominal flap the Scarpa´s fascia is removed.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
The patient will not know if the Scarpa´s fascia has been removed or preserved.
Eligibility
Sex/Gender
FEMALE
Age
24 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Participant flow
Recruitment details
The recruitment began in october 2014 until april 2015 at Hospital Santo Amaro (private hospital), in Guarujá city, Brazil.
Participants by arm
| Arm | Count |
|---|---|
| No Keeping Scarpa's Fascia Abdominoplasty in anchor-line without keeping Scarpa's Fascia.
Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups | 23 |
| Keeping Scarpa's Fascia Abdominoplasty in anchor-line keeping Scarpa's Fascia.
Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups | 23 |
| Total | 46 |
Baseline characteristics
| Characteristic | No Keeping Scarpa's Fascia | Keeping Scarpa's Fascia | Total |
|---|---|---|---|
| Age, Continuous | 37.086 years STANDARD_DEVIATION 8.06 | 38.1304 years STANDARD_DEVIATION 8.05 | 37.6087 years STANDARD_DEVIATION 8.074 |
| BMI | 26.4 Kg/m2 STANDARD_DEVIATION 3 | 28.2 Kg/m2 STANDARD_DEVIATION 1.9 | 27.3 Kg/m2 STANDARD_DEVIATION 2.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 23 Participants | 23 Participants | 46 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Brazil | 23 participants | 23 participants | 46 participants |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 46 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
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.
Time frame: number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Scarpa's Fascia | Total Volume of Drainage in ml. | 428.9 ml | Standard Deviation 222.6 |
| With Scarpa's Fascia | Total Volume of Drainage in ml. | 249.1 ml | Standard Deviation 98.2 |
p-value: 0.003Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Scarpa's Fascia | Number of Days Required for Drain Withdrawal. | 5.4 days | Standard Deviation 1.9 |
| With Scarpa's Fascia | Number of Days Required for Drain Withdrawal. | 4.2 days | Standard Deviation 1.2 |
p-value: 0.012t-test, 2 sided
Secondary
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.
Time frame: Done after 20 days of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Without Scarpa's Fascia | Volume of Seroma Assessed by Ultrasound of the Abdominal Wall. | 21.6 ml | Standard Deviation 40.7 |
| With Scarpa's Fascia | Volume of Seroma Assessed by Ultrasound of the Abdominal Wall. | 16.8 ml | Standard Deviation 25 |
p-value: 0.809Wilcoxon (Mann-Whitney)