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

NCT ID: NCT01942707

Last Updated: 2018-03-29

Study Results

Results available

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Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Seroma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
The patient will not know if the Scarpa´s fascia has been removed or preserved.

Study Groups

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Abdominoplasty without Scarpa´s Facia

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

Group Type ACTIVE_COMPARATOR

Abdominoplasty without Scarpa´s Facia

Intervention Type PROCEDURE

During surgical detachment of the abdominal flap the Scarpa´s fascia is removed.

abdominoplasty with Scarpa's Fascia

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

Group Type EXPERIMENTAL

abdominoplasty with Scarpa's Fascia

Intervention Type PROCEDURE

During surgical detachment of the abdominal flap the Scarpa´s fascia is preserved.

Interventions

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abdominoplasty with Scarpa's Fascia

During surgical detachment of the abdominal flap the Scarpa´s fascia is preserved.

Intervention Type PROCEDURE

Abdominoplasty without Scarpa´s Facia

During surgical detachment of the abdominal flap the Scarpa´s fascia is removed.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

24 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Heraldo Carlos Borges

M D - Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lydia M Ferreira, MD, Phd

Role: STUDY_CHAIR

Federal University of São Paulo

Juan C Montano-Pedroso, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

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Federal University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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INFORZATO55

Identifier Type: -

Identifier Source: org_study_id

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