Manual Lymphatic Drainage in Women Undergone to Thigh Lifting

Study Overview
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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.

Official Title
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Manual Lymphatic Drainage in Women Undergone to Thigh Lifting After Bariatric Surgery

Conditions
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Lymphedema, Obesity

Intervention / Treatment
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* Procedure: Thigh Surgery


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>This group will not be undergoing to manual lymphatic drainage | Procedure: Thigh Surgery<br>* Circumferential thigh surgery post bariatric surgery<br>* Other names: Postobesity surgery;|
| Active Comparator: Study Group<br>This group will be undergoing to manual lymphatic drainage | Procedure: Thigh Surgery<br>* Circumferential thigh surgery post bariatric surgery<br>* Other names: Postobesity surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one day before surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7th postoperative day | 
| 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 | 9th postoperative day | 
| 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. | 14th postoperative day | 
| 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. | 16th postoperative day | 
| 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. | 21th postoperative day | 
| 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. | 28th postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphedema, Magnetic Resonance Imaging, Plastic Surgery