Terapia fisica nella chirurgia del lipedema
Intervento di terapia fisica nella fase postoperatoria immediata della chirurgia del lipedema
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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Madrid
-
Alcalá de Henares, Madrid, Spagna, 28823
- Ester Cerezo Tellez
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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).
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: ECOLOGIC_OR_COMMUNITY
- Prospettive temporali: RETROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain Visual Analogue Scale
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
edema resorption - volume
Lasso di tempo: 2018-2022
|
lower limb edema is measured |
2018-2022
|
|
complications reported - binary outcome
Lasso di tempo: 2018-2022
|
seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema |
2018-2022
|
|
mobility - scale
Lasso di tempo: 2018-2022
|
1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement |
2018-2022
|
|
patient satisfaction
Lasso di tempo: 2018-2022
|
binary outcome |
2018-2022
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- OE36/2023
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .