Manual Lymphatic Drainage in Women Undergone to Thigh Lifting

NCT ID: NCT01470378

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-11-30

Brief Summary

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This study will investigate the subcutaneous tissue changes in the lymphedema found after thigh surgery, by circumferential measure of thr thighs and by magnetic resonance imaging verifying the effects of postoperative lymphatic drainage.

Detailed Description

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Patients will be invited to participate in the study, divided into two groups, and randomized to treatment by wwww.randomization.com, where 10 patients will participate in the study group(20 legs) and 10 control group patients(20 legs). Total of 40 legs. Then, the evaluation will be performed on preoperative time, consisting of physical examination and circumferential measures. Others measurements will be taken im postoperative time and confirmed by magnetic resonance.

Conditions

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Lymphedema Obesity

Keywords

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Lymphedema Magnetic Resonance Imaging Plastic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

This group will not be undergoing to manual lymphatic drainage

Group Type ACTIVE_COMPARATOR

Thigh Surgery

Intervention Type PROCEDURE

Circumferential thigh surgery post bariatric surgery

Study Group

This group will be undergoing to manual lymphatic drainage

Group Type ACTIVE_COMPARATOR

Thigh Surgery

Intervention Type PROCEDURE

Circumferential thigh surgery post bariatric surgery

Interventions

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Thigh Surgery

Circumferential thigh surgery post bariatric surgery

Intervention Type PROCEDURE

Other Intervention Names

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Thigh plastic surgery Postobesity surgery

Eligibility Criteria

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Inclusion Criteria

* Female patients
* Age between 30 and 60 years old
* Bariatric Surgery Capella Previous Type
* Stabilization of weight loss for 1 year or more
* Patients with a body mass index less than or equal to 30 kg/m2

Exclusion Criteria

* Pregnancy, childbirth or breastfeeding for less than 1 year
* Presence of uncontrolled systemic disease
* Other disease that require surgical interventions
* Lymphatic or venous pathologies in advance
* Patients over 110 kg
* Patients with a body mass index(BMI) greater than 30 kg/m2
* Patients who has undergone plastic surgery of the thighs
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Lilia Cristina de Arruda

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lydia M Ferreira, MD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Elvio B Garcia, MD

Role: primary

Lilia C Arruda, PhD

Role: backup

References

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Le Louarn C, Pascal JF. The concentric medial thigh lift. Aesthetic Plast Surg. 2004 Jan-Feb;28(1):20-3. doi: 10.1007/s00266-003-3095-x. Epub 2004 Mar 25.

Reference Type BACKGROUND
PMID: 15037958 (View on PubMed)

Nemerofsky RB, Oliak DA, Capella JF. Body lift: an account of 200 consecutive cases in the massive weight loss patient. Plast Reconstr Surg. 2006 Feb;117(2):414-30. doi: 10.1097/01.prs.0000197524.18233.bb.

Reference Type BACKGROUND
PMID: 16462321 (View on PubMed)

Pascal JF, Le Louarn C. Remodeling bodylift with high lateral tension. Aesthetic Plast Surg. 2002 May-Jun;26(3):223-30. doi: 10.1007/s00266-002-1478-z.

Reference Type BACKGROUND
PMID: 12140705 (View on PubMed)

Moreno CH, Neto HJ, Junior AH, Malheiros CA. Thighplasty after bariatric surgery: evaluation of lymphatic drainage in lower extremities. Obes Surg. 2008 Sep;18(9):1160-4. doi: 10.1007/s11695-007-9400-z. Epub 2008 Jun 11.

Reference Type BACKGROUND
PMID: 18546051 (View on PubMed)

Kolker AR, Xipoleas GD. The circumferential thigh lift and vertical extension circumferential thigh lift: maximizing aesthetics and safety in lower extremity contouring. Ann Plast Surg. 2011 May;66(5):452-6. doi: 10.1097/SAP.0b013e3182145682.

Reference Type BACKGROUND
PMID: 21451373 (View on PubMed)

Related Links

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http://www.obesity.org/

The Obesity Society is the leading scientific society dedicated to the study of obesity

http://www.obesity-online.com/

OBESITY - ONLINE is a multi-disciplinary forum for research and treatment of massive obesity, including plastics, psychiatry, endocrinology, nutrition, nursing, dietetics and allied health

Other Identifiers

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UNIFESP_LILIA

Identifier Type: -

Identifier Source: org_study_id