NCT01470378

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

November 2, 2011

Last Update Submit

August 7, 2013

Conditions

LymphedemaObesity

Keywords

LymphedemaMagnetic Resonance ImagingPlastic Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Thighs circumference measurement

    7th postoperative day

  • Thighs circumference measurement

    9th postoperative day

  • Thighs circumference measurement

    14th postoperative day

  • Thighs circumference measurement

    16th postoperative day

  • Thighs circumference measurement

    21th postoperative day

  • +1 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

This group will not be undergoing to manual lymphatic drainage

Procedure: Thigh Surgery

Study Group

ACTIVE COMPARATOR

This group will be undergoing to manual lymphatic drainage

Procedure: Thigh Surgery

Interventions

Thigh SurgeryPROCEDURE

Circumferential thigh surgery post bariatric surgery

Also known as: Thigh plastic surgery, Postobesity surgery
Control GroupStudy Group

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023-900, Brazil

RECRUITING

Related Publications (5)

  • 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.

    PMID: 15037958BACKGROUND

  • 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.

    PMID: 16462321BACKGROUND

  • 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.

    PMID: 12140705BACKGROUND

  • 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.

    PMID: 18546051BACKGROUND

  • 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.

    PMID: 21451373BACKGROUND

Related Links

MeSH Terms

Conditions

LymphedemaObesity

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lydia M Ferreira, MD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 2, 2011

First Posted

November 11, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2013

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations

BR(1)