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Manual Lymphatic Drainage in Women Undergone to Thigh Lifting (Thight_lift)

Primary Purpose

Lymphedema, Obesity

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Thigh Surgery
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring Lymphedema, Magnetic Resonance Imaging, Plastic Surgery

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Federal University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control Group

Study Group

Arm Description

This group will not be undergoing to manual lymphatic drainage

This group will be undergoing to manual lymphatic drainage

Outcomes

Primary Outcome Measures

Preoperative measurement.
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first measurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them. After the measurement, a Magnetic Resonance of the thighs is made.

Secondary Outcome Measures

Thighs circumference measurement
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them
Thighs circumference measurement
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them
Thighs circumference measurement
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them. After the measurement, a Magnetic Resonance of the thighs is made.
Thighs circumference measurement
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them.
Thighs circumference measurement
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them.
Thighs circumference measurement
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them. After the measurement, a Magnetic Resonance of the thighs is made.

Full Information

First Posted
November 2, 2011
Last Updated
August 7, 2013
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01470378
Brief Title
Manual Lymphatic Drainage in Women Undergone to Thigh Lifting
Acronym
Thight_lift
Official Title
Manual Lymphatic Drainage in Women Undergone to Thigh Lifting After Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2013 (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
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Obesity
Keywords
Lymphedema, Magnetic Resonance Imaging, Plastic Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
This group will not be undergoing to manual lymphatic drainage
Arm Title
Study Group
Arm Type
Active Comparator
Arm Description
This group will be undergoing to manual lymphatic drainage
Intervention Type
Procedure
Intervention Name(s)
Thigh Surgery
Other Intervention Name(s)
Thigh plastic surgery, Postobesity surgery
Intervention Description
Circumferential thigh surgery post bariatric surgery
Primary Outcome Measure Information:
Title
Preoperative measurement.
Description
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first measurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them. After the measurement, a Magnetic Resonance of the thighs is made.
Time Frame
one day before surgery
Secondary Outcome Measure Information:
Title
Thighs circumference measurement
Description
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them
Time Frame
7th postoperative day
Title
Thighs circumference measurement
Description
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them
Time Frame
9th postoperative day
Title
Thighs circumference measurement
Description
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them. After the measurement, a Magnetic Resonance of the thighs is made.
Time Frame
14th postoperative day
Title
Thighs circumference measurement
Description
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them.
Time Frame
16th postoperative day
Title
Thighs circumference measurement
Description
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them.
Time Frame
21th postoperative day
Title
Thighs circumference measurement
Description
Thigh circumference measurements made with anthropometric metal tape and a Permanent Marker, based in bone parameters in supine position. Using as reference the bony protuberance of the trochanter, the first mesurement will be taken 5 (five) cm below this point and 5 (five) cm above the patella, and betwin this two points will be made one mark at the midpoint between them. After the measurement, a Magnetic Resonance of the thighs is made.
Time Frame
28th postoperative day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia M Ferreira, MD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04023-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elvio B Garcia, MD
Phone
551155739525
Email
elvio@uol.com.br
First Name & Middle Initial & Last Name & Degree
Lilia C Arruda, PhD
Phone
551150965996
First Name & Middle Initial & Last Name & Degree
Lilia C Arruda, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15037958
Citation
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.
Results Reference
background
PubMed Identifier
16462321
Citation
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.
Results Reference
background
PubMed Identifier
12140705
Citation
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.
Results Reference
background
PubMed Identifier
18546051
Citation
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.
Results Reference
background
PubMed Identifier
21451373
Citation
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.
Results Reference
background
Links:
URL
http://www.obesity.org/
Description
The Obesity Society is the leading scientific society dedicated to the study of obesity
URL
http://www.obesity-online.com/
Description
OBESITY - ONLINE is a multi-disciplinary forum for research and treatment of massive obesity, including plastics, psychiatry, endocrinology, nutrition, nursing, dietetics and allied health

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Manual Lymphatic Drainage in Women Undergone to Thigh Lifting

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