Manual Lymphatic Drainage in Women Undergone to Thigh Lifting

Overview

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.

Full Title of Study: “Manual Lymphatic Drainage in Women Undergone to Thigh Lifting After Bariatric Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2012

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.

Interventions

  • Procedure: Thigh Surgery
    • Circumferential thigh surgery post bariatric surgery

Arms, Groups and Cohorts

  • Active Comparator: Control Group
    • This group will not be undergoing to manual lymphatic drainage
  • Active Comparator: Study Group
    • This group will be undergoing to manual lymphatic drainage

Clinical Trial Outcome Measures

Primary Measures

  • Preoperative measurement.
    • Time Frame: one day before surgery
    • 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 Measures

  • Thighs circumference measurement
    • Time Frame: 7th postoperative day
    • 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
    • Time Frame: 9th postoperative day
    • 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
    • Time Frame: 14th postoperative day
    • 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
    • Time Frame: 16th postoperative day
    • 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
    • Time Frame: 21th postoperative day
    • 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
    • Time Frame: 28th postoperative day
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 30 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Federal University of São Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lilia Cristina de Arruda, Principal Investigator – Federal University of São Paulo
  • Overall Official(s)
    • Lydia M Ferreira, MD, Study Chair, Federal University of Sao Paulo

References

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.

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.

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.

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.

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.

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