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

Primary Purpose

Seroma

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
abdominoplasty with Scarpa's Fascia
Abdominoplasty without Scarpa´s Facia
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seroma focused on measuring Abdominoplasty,Seroma,Bariatric surgery

Eligibility Criteria

24 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Abdominoplasty without Scarpa´s Facia

abdominoplasty with Scarpa's Fascia

Arm Description

Anchor-line abdominoplasty where the Scarpa's Fascia will be removed.

Anchor-line abdominoplasty where the Scarpa's Fascia will be preserved.

Outcomes

Primary Outcome Measures

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of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours.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

Secondary Outcome Measures

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of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours.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

Full Information

First Posted
September 11, 2013
Last Updated
March 1, 2018
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01942707
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma
Keywords
Abdominoplasty,Seroma,Bariatric surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The patient will not know if the Scarpa´s fascia has been removed or preserved.
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abdominoplasty without Scarpa´s Facia
Arm Type
Active Comparator
Arm Description
Anchor-line abdominoplasty where the Scarpa's Fascia will be removed.
Arm Title
abdominoplasty with Scarpa's Fascia
Arm Type
Experimental
Arm Description
Anchor-line abdominoplasty where the Scarpa's Fascia will be preserved.
Intervention Type
Procedure
Intervention Name(s)
abdominoplasty with Scarpa's Fascia
Intervention Description
During surgical detachment of the abdominal flap the Scarpa´s fascia is preserved.
Intervention Type
Procedure
Intervention Name(s)
Abdominoplasty without Scarpa´s Facia
Intervention Description
During surgical detachment of the abdominal flap the Scarpa´s fascia is removed.
Primary Outcome Measure Information:
Title
Total Volume of Drainage in ml.
Description
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
Secondary Outcome Measure Information:
Title
Number of Days Required for Drain Withdrawal.
Description
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
Title
Volume of Seroma Assessed by Ultrasound of the Abdominal Wall.
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia M Ferreira, MD, Phd
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Juan C Montano-Pedroso, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04024002
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
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Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery

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