Clinical trial NCT06167993: Complex Decongestive Physiotherapy Applied After Lymphovenous Anastomosis Surgery
Official title: Effect of Complex Decongestive Physiotherapy Applied After Lymphovenous Anastomosis Surgery on Extremity Volume, Quality of Life and Patient Satisfaction (Randomized Controlled Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphedema
Cancer
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tape Measure
timeFrame: 5 months
Secondary outcomes:
measure: Lymphedema Function, Disability and Health Questionnaire-Lower Extremity (LYMPH ICF-LL) Scale
timeFrame: 5 months
measure: Visual Analogue Scale (VAS)
timeFrame: 5 months
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Bilsev İnce
city: Konya
country: Turkey
facility: Hanife Dogan
Study officials:
References: