Trial record 8 of 9 for:
Open Studies | "Surgery, Plastic"
Manual Lymphatic Drainage in Women Undergone to Thigh Lifting (Thight_lift)
This study is currently recruiting participants.
Verified November 2011 by Federal University of São Paulo
Sponsor:
Federal University of São Paulo
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: November 10, 2011
Last verified: November 2011
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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 2012 |
| Primary Completion Date: | October 2011 (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:
|
|
Active Comparator: Study Group
This group will be undergoing to manual lymphatic drainage
|
Procedure: Thigh Surgery
Circumferential thigh surgery post bariatric surgery
Other Names:
|
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
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: | November 10, 2011 |
| 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 Obesity Lymphatic Diseases Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013