## Protocol Section
### Identification Module
**NCT ID:** NCT05966779

**Brief Title:** Physical Therapy in Lipedema Surgery

**Official Title:** Physical Therapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery

#### Organization Study ID Info
**ID:** OE36/2023
#### Organization
**Class:** OTHER
**Full Name:** University of Alcala
### Status Module
#### Completion Date
**Date:** 2023-07-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-01

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-07-12

**Type:** ACTUAL

#### Start Date
**Date:** 2023-07-01

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2023-08-01
**Type:** ACTUAL
**Study First Submit Date:** 2023-07-20
**Study First Submit QC Date:** 2023-07-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Alcala

#### Responsible Party

**Investigator Affiliation:** University of Alcala

**Investigator Full Name:** Ester Cerezo-Téllez

**Investigator Title:** PhD., Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Assessment

- Lipedema

- Vascular Diseases

- Dermatologic Complication

**Keywords:**

- Lipedema, physical therapy,liposuction,complications,treatment,assessment

### Design Module

#### Design Info

**Observational Model:** ECOLOGIC_OR_COMMUNITY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 293

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

1. Cervical Stimuli 15min
2. MLD based on Godoy
3. Mechanical lymphatic drainage with RA Godoy® device
4. Compression therapy with multilayer and multicomponent bandages during the mechanical lymphatic drainage.
5. Skin care - before and after the bandages- and therapeutic education.
6. Put on compression garments
7. Active movement if possible.

**Intervention Names:**

- Other: modified CDT physical therapy protocol, based on Godoy's Method

**Label:** modified CDT physical therapy protocol, based on Godoy's Method

### Interventions

#### Intervention 1

**Arm Group Labels:**

- modified CDT physical therapy protocol, based on Godoy's Method

**Description:** modified CDT physical therapy protocol

**Name:** modified CDT physical therapy protocol, based on Godoy's Method

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** VAS

**Measure:** Pain VAS scale

**Time Frame:** 2018-2022

#### Secondary Outcomes

**Description:** lower limb edema is measured

**Measure:** edema resorption - volume

**Time Frame:** 2018-2022

**Description:** seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema

**Measure:** complications reported - binary outcome

**Time Frame:** 2018-2022

**Description:** 1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement

**Measure:** mobility - scale

**Time Frame:** 2018-2022

**Description:** binary outcome

**Measure:** patient satisfaction

**Time Frame:** 2018-2022

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** 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).

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Alcalá de Henares

**Country:** Spain

**Facility:** Ester Cerezo Tellez

**State:** Madrid

**Zip:** 28823

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M17400

- Name: Vascular Diseases

- Relevance: HIGH

- As Found: Vascular Disease

- ID: M30472

- Name: Lipedema

- Relevance: HIGH

- As Found: Lipedema

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014652

- Term: Vascular Diseases

- ID: D000065134

- Term: Lipedema

### Misc Info Module

- Version Holder: 2024-05-24
