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Complex Decongestive Physiotherapy Applied After Lymphovenous Anastomosis Surgery

Effect of Complex Decongestive Physiotherapy Applied After Lymphovenous Anastomosis Surgery on Extremity Volume, Quality of Life and Patient Satisfaction (Randomized Controlled Study)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06167993
Enrollment
26
Registered
2023-12-13
Start date
2023-08-21
Completion date
2024-06-15
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema, Cancer

Brief summary

Type of this study: Prospective randomized controlled study. The aim of our study is to compare patients with lymphedema who have undergone lymphovenous anastomosis surgery receiving Complex Decongestive Physiotherapy (CDP), patients with lymphedema who have not undergone surgery who receive Complex Decongestive Physiotherapy, in terms of Extremity Volume, Quality of Life and Patient Satisfaction. 26 volunteers will be included in the study as patients with lymphedema who have undergone lymphovenous anastomosis surgery and KBF (n=13), only KBF (n=13), application groups. How effective is lymphovenous anastomosis surgery and KBF or only CDP acutely in the treatment of lymhedema?

Detailed description

Lymphedema (LE) is a chronic and progressive condition that occurs as a result of abnormal accumulation of protein-rich fluid in the interstitial space due to inadequate lymphatic drainage. The gold standard treatment program among physiotherapy applications is the Complex Decongestive Physiotherapy application. It consists of four basic components; Manual Lymph Drainage, Skin Care, Compression Therapy, Therapeutic Exercise. All patients will receive the treatment phase of KBF for 20 sessions, 5 days a week: Treatment; The 45-minute MLD consists of skin care, compression therapy with a short-draft bandage that they will then use for 23 hours a day, decongestive exercises and suggestions to facilitate venous and lymphatic flow. The effect of CDP will be compared in patients who have had lymphovenous anastomosis surgery and those who have not. Quality of life of patients related to lymphedema; Lymphedema Function, Disability and Health Questionnaire-Lower Extremity (LYMPH ICF-LL), satisfaction levels will be evaluated with the Visual analog scale, and the amount of edema will be evaluated with circumference measurement.

Interventions

Complex Decongestive Physiotherapy; It consists of manual therapy, skin care, compression therapy and therapeutic exercise.

Sponsors

Necmettin Erbakan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Between the ages of 18-65, * Having unilateral lower extremity or upper extremity lymphedema, * Being diagnosed with Stage 2 and 3 lymphedema, * Receiving lymphedema therapy for the first time, * Adjuvant chemotherapy for gynecological cancer, * Having completed radiation and surgical treatment at least 3 months and at most 5 years ago, * Patients with lymph vessels seen on lymphangiography, * Patients who have undergone LVA surgery and 1 month has passed since the surgery date * No evidence of disease recurrence at last follow-up visit and * Individuals willing to participate in the study

Exclusion criteria

* Those who do not volunteer to participate in the study, * Those with bilateral lower extremity lymphedema, * Having upper or lower extremity edema due to systemic disease, * Those with active infection, * Patients more than 1.5 months after LVA surgery * Known to have mental and cognitive disorders * Those who were unable to communicate and cooperate were not included.

Design outcomes

Primary

MeasureTime frameDescription
Tape Measure5 monthsExtremity Volume; In calculating the circumference measurements of the lower and upper extremities, the circumference of the healthy and diseased extremities is measured at 4 cm intervals with the help of a tape measure. These circumference measurements (thickest and thinnest circumference measurement values) are then converted to volumetric measurements using the Frustum Formula.

Secondary

MeasureTime frameDescription
Lymphedema Function, Disability and Health Questionnaire-Lower Extremity (LYMPH ICF-LL) Scale5 monthsEvaluates patients' quality of life related to lymphedema.
Visual Analogue Scale (VAS)5 monthsVAS: A 10 cm visual analogue scale was used to evaluate the patients' satisfaction levels with the physiotherapy they received. The same evaluation was repeated before and after treatment. The patient will be asked to mark a field between the highest value of satisfaction level, 10, and the lowest value, 0.

Countries

Turkey (Türkiye)

Contacts

Primary ContactHanife Dogan, Assoc.Prof.
hanife_dogan@yahoo.com.tr+905075346142
Backup ContactBilsev İnce, Prof.
bilsevince@yahoo.com+905552776488

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026