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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Federal University of São Paulo
Sponsor:
Information provided by (Responsible Party):
Lilia Cristina de Arruda, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01470378
First received: November 2, 2011
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Lymphedema
Obesity
Procedure: Thigh Surgery
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Manual Lymphatic Drainage in Women Undergone to Thigh Lifting After Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Preoperative measurement. [ Time Frame: one day before surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 7th postoperative day ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: November 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group
This group will not be undergoing to manual lymphatic drainage
Procedure: Thigh Surgery
Circumferential thigh surgery post bariatric surgery
Other Names:
  • Thigh plastic surgery
  • Postobesity surgery
Active Comparator: Study Group
This group will be undergoing to manual lymphatic drainage
Procedure: Thigh Surgery
Circumferential thigh surgery post bariatric surgery
Other Names:
  • Thigh plastic surgery
  • Postobesity surgery

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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470378

Locations
Brazil
Federal University of Sao Paulo Recruiting
Sao Paulo, Brazil, 04023-900
Contact: Elvio B Garcia, MD    551155739525    elvio@uol.com.br   
Contact: Lilia C Arruda, PhD    551150965996      
Principal Investigator: Lilia C Arruda, PhD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Lydia M Ferreira, MD Federal University of Sao Paulo
  More Information

Additional Information:
Publications:
Responsible Party: Lilia Cristina de Arruda, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01470378     History of Changes
Other Study ID Numbers: UNIFESP_LILIA
Study First Received: November 2, 2011
Last Updated: August 7, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
Lymphedema
Magnetic Resonance Imaging
Plastic Surgery

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014