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The goal of this observational study or clinical trial is to know evaluate the effects of a modified Complete Decongestive Therapy protocol using the Godoy Method in the postoperative period following lipedema surgery.
The main question it aims to answer are:
Participants have been treated in the lasts years and authors recover information of the effects of the treatment.
Researchers will compare sub-groups of participants depending on the number of physical therapy sessions received
Background: Lipedema is an adipose tissue disorder in women, with an abnormal fat deposition in lower limbs and occasionally upper limbs. The patients present pain, bruising, heaviness, and mobility impairment. It affects them physically and psychologically. Purpose: This study aims to evaluate the effects of a modified CDT protocol using the Godoy Method in the postoperative period following lipedema surgery.
Outcomes: pain (VAS), edema resorption, complications, mobility and patient satisfaction.
A descriptive statistical analysis will be performed using means and standard deviation (quantitative outcomes) and percentages (dichotomous and categorical outcomes). An inferential analysis will be carried out using paired and unpaired T-tests as One-way and repeated measures ANOVA to search for differences between quantitative outcomes. Pearson chi-square will also be used to relate dichotomous and categorical variables in a transversal analysis. All missing values will be excluded from the analysis. In all cases, a P<0.05 value and a 95% confidence interval will be determined forstatistical significance. All statistical analysis will be performed using the Stata® version 14.2 package for MS Windows® version 10.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| modified CDT physical therapy protocol, based on Godoy's Method | A complete physical therapy assessment was done. All sociodemographic data were recruited as well as body mass index (BMI), the month of intervention, kind of surgery, extracted liters, psychological treatment, physical therapy sessions, pain, mobility, complications (seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema), compression, smoking, satisfaction with the treatment received. A modified CDT physical therapy protocol, based on Godoy's Method, was applied to all study participants. This protocol comprised of
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified CDT physical therapy protocol, based on Godoy's Method | Other | modified CDT physical therapy protocol |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain VAS scale | VAS | 2018-2022 |
| Measure | Description | Time Frame |
|---|---|---|
| edema resorption - volume | lower limb edema is measured | 2018-2022 |
| complications reported - binary outcome | seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema |
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Inclusion Criteria:
Exclusion Criteria:
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females from undergon a surgical proceeding for lipedema in two private hospitals in Madrid and were treated in a private physical therapy center. After surgery they were recommended to receive CDT by their surgeons. All participants received the same physical therapy treatment. The study was approved by the Clinical Research Committee of Hospital Universitario Principe de Asturias (CEIm 36/2023).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ester Cerezo Tellez | Alcalá de Henares | Madrid | 28823 | Spain |
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| ID | Term |
|---|---|
| D065134 | Lipedema |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002318 | Cardiovascular Diseases |
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| 2018-2022 |
| mobility - scale | 1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement | 2018-2022 |
| patient satisfaction | binary outcome | 2018-2022 |