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Trial Outcomes & Findings for Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery (NCT NCT01942707)

NCT ID: NCT01942707

Last Updated: 2018-03-29

Results Overview

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of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours.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

Recruitment status

UNKNOWN

Study phase

NA

Target enrollment

46 participants

Primary outcome timeframe

number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days

Results posted on

2018-03-29

Participant Flow

The recruitment began in october 2014 until april 2015 at Hospital Santo Amaro (private hospital), in Guarujá city, Brazil.

Participant milestones

Participant milestones
Measure
Anchor-line Abdominoplasty Without Scarpa's Fascia
Anchor-line abdominoplasty. The Scarpa's Fascia will be removed in this group.
Anchor-line Abdominoplasty With Scarpa's Fascia
Anchor-line abdominoplasty. In this group the Scarpa's Fascia will be preserved.
Overall Study
STARTED
23
23
Overall Study
COMPLETED
23
23
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
No Keeping Scarpa's Fascia
n=23 Participants
Abdominoplasty in anchor-line without keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups
Keeping Scarpa's Fascia
n=23 Participants
Abdominoplasty in anchor-line keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups
Total
n=46 Participants
Total of all reporting groups
Age, Continuous
37.086 years
STANDARD_DEVIATION 8.06 • n=5 Participants
38.1304 years
STANDARD_DEVIATION 8.05 • n=7 Participants
37.6087 years
STANDARD_DEVIATION 8.074 • n=5 Participants
Sex: Female, Male
Female
23 Participants
n=5 Participants
23 Participants
n=7 Participants
46 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
23 Participants
n=5 Participants
23 Participants
n=7 Participants
46 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
Brazil
23 participants
n=5 Participants
23 participants
n=7 Participants
46 participants
n=5 Participants
BMI
26.4 Kg/m2
STANDARD_DEVIATION 3 • n=5 Participants
28.2 Kg/m2
STANDARD_DEVIATION 1.9 • n=7 Participants
27.3 Kg/m2
STANDARD_DEVIATION 2.6 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Without Scarpa's Fascia
n=23 Participants
Abdominoplasty in anchor-line without keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups
With Scarpa's Fascia
n=23 Participants
Abdominoplasty in anchor-line keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups
Total Volume of Drainage in ml.
428.9 ml
Standard Deviation 222.6
249.1 ml
Standard Deviation 98.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Without Scarpa's Fascia
n=23 Participants
Abdominoplasty in anchor-line without keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups
With Scarpa's Fascia
n=23 Participants
Abdominoplasty in anchor-line keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups
Number of Days Required for Drain Withdrawal.
5.4 days
Standard Deviation 1.9
4.2 days
Standard Deviation 1.2

SECONDARY outcome

Timeframe: Done after 20 days of surgery

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

Outcome measures

Outcome measures
Measure
Without Scarpa's Fascia
n=23 Participants
Abdominoplasty in anchor-line without keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups
With Scarpa's Fascia
n=23 Participants
Abdominoplasty in anchor-line keeping Scarpa's Fascia. Abdominoplasty in anchor-line: Abdominoplasty in anchor-line was performed in both groups
Volume of Seroma Assessed by Ultrasound of the Abdominal Wall.
21.6 ml
Standard Deviation 40.7
16.8 ml
Standard Deviation 25

Adverse Events

Anchor-line Abdominoplasty Without Scarpa's Fascia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Anchor-line Abdominoplasty With Scarpa's Fascia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heraldo Carlos Borges Inforzato

Universidade Federal de São Paulo

Phone: 55-13-997112644

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place