An interventional study of abdominoplasty with Scarpa's Fascia and Abdominoplasty without Scarpa´s Facia in Seroma, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to female participants aged 24 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Prevention
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.
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.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's enrollment of 46 is below the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →Federal University of São Paulo is the lead sponsor of 439 studies on the registry; 23 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anchor-line abdominoplasty where the Scarpa's Fascia will be removed.
Procedure: Abdominoplasty without Scarpa´s Facia
Anchor-line abdominoplasty where the Scarpa's Fascia will be preserved.
Procedure: abdominoplasty with Scarpa's Fascia
During surgical detachment of the abdominal flap the Scarpa´s fascia is preserved.
During surgical detachment of the abdominal flap the Scarpa´s fascia is removed.
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
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
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
The recruitment began in october 2014 until april 2015 at Hospital Santo Amaro (private hospital), in Guarujá city, Brazil.
| Milestone | Anchor-line Abdominoplasty Without Scarpa's Fascia | Anchor-line Abdominoplasty With Scarpa's Fascia |
|---|---|---|
| Started | 23 | 23 |
| Completed | 23 | 23 |
| Not completed | 0 | 0 |
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.
| ml | Without Scarpa's Fascia | With Scarpa's Fascia |
|---|---|---|
| Total Volume of Drainage in ml. | 428.9 ± 222.6 | 249.1 ± 98.2 |
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.
| days | Without Scarpa's Fascia | With Scarpa's Fascia |
|---|---|---|
| Number of Days Required for Drain Withdrawal. | 5.4 ± 1.9 | 4.2 ± 1.2 |
An ultrasound of the abdominal wall will be realized to check the volume of any residual seroma.
| ml | Without Scarpa's Fascia | With Scarpa's Fascia |
|---|---|---|
| Volume of Seroma Assessed by Ultrasound of the Abdominal Wall. | 21.6 ± 40.7 | 16.8 ± 25 |
Collected over 60 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anchor-line Abdominoplasty Without Scarpa's Fascia | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Anchor-line Abdominoplasty With Scarpa's Fascia | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Age, Continuous(years) | No Keeping Scarpa's Fascia | Keeping Scarpa's Fascia | Total |
|---|---|---|---|
| Mean | 37.086 ± 8.06 | 38.1304 ± 8.05 | 37.6087 ± 8.074 |
| Sex: Female, Male(Participants) | No Keeping Scarpa's Fascia | Keeping Scarpa's Fascia | Total |
|---|---|---|---|
| Female | 23 | 23 | 46 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | No Keeping Scarpa's Fascia | Keeping Scarpa's Fascia | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 23 | 23 | 46 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | No Keeping Scarpa's Fascia | Keeping Scarpa's Fascia | Total |
|---|---|---|---|
| Brazil | 23 | 23 | 46 |
| BMI(Kg/m2) | No Keeping Scarpa's Fascia | Keeping Scarpa's Fascia | Total |
|---|---|---|---|
| Mean | 26.4 ± 3 | 28.2 ± 1.9 | 27.3 ± 2.6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Mar 2013, a primary completion of Apr 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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