Fysioterapi ved lipødemkirurgi
Fysioterapiintervention i den umiddelbare postoperative fase af lipødemkirurgi
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:
- if the treatment is effective on pain reduction, edema resorption, mobility improvement in short term and follow-up at 90 days
- if the treatment is effective on preventing complications of these participants after surgery
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Madrid
-
Alcalá de Henares, Madrid, Spanien, 28823
- Ester Cerezo Tellez
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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).
Beskrivelse
Inclusion Criteria:
- female subject who underwent a lipedema surgery
- recommendation of the surgeon to receive physical therapy
Exclusion Criteria:
- unilateral surgery
- lack of data in the clinical history
- only 1-2 physical therapy sessions
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: ECOLOGIC_OR_COMMUNITY
- Tidsperspektiver: RETROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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
|
modified CDT physical therapy protocol |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Visual Analogue Scale
Tidsramme: Baseline, short-term (post-treatment), and 90 days follow-up
|
Pain assessed using the Visual Analogue Scale (VAS). Scores range from 0 mm (no pain) to 100 mm (worst imaginable pain), where higher scores indicate worse pain. |
Baseline, short-term (post-treatment), and 90 days follow-up
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
edema resorption - volume
Tidsramme: 2018-2022
|
lower limb edema is measured |
2018-2022
|
|
complications reported - binary outcome
Tidsramme: 2018-2022
|
seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema |
2018-2022
|
|
mobility - scale
Tidsramme: 2018-2022
|
1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement |
2018-2022
|
|
patient satisfaction
Tidsramme: 2018-2022
|
binary outcome |
2018-2022
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OE36/2023
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