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

March 1, 2018 updated by: Heraldo Carlos Borges, Federal University of São Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04024002
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Abdominoplasty without Scarpa´s Facia
Anchor-line abdominoplasty where the Scarpa's Fascia will be removed.
Procedure: Abdominoplasty without Scarpa´s Facia
During surgical detachment of the abdominal flap the Scarpa´s fascia is removed.
Experimental: abdominoplasty with Scarpa's Fascia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Volume of Drainage in ml.
Time Frame: 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.
number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Days Required for Drain Withdrawal.
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. 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.
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.
Time Frame: Done after 20 days of surgery
An ultrasound of the abdominal wall will be realized to check the volume of any residual seroma.
Done after 20 days of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Chair: Lydia M Ferreira, MD, PhD, Federal University of São Paulo
  • Study Chair: Juan C Montano-Pedroso, PhD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

September 11, 2013

First Posted (Estimate)

September 16, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INFORZATO55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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