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NCT Number: NCT06167993

Complex Decongestive Physiotherapy Applied After Lymphovenous Anastomosis Surgery

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?

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Key information

Conditions

Lymphedema Cancer Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hanife Dogan, Konya, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Complex Decongestive Physiotherapy

Behavioral

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

Primary outcomes

  1. Tape Measure

    Time frame: 5 months

    Extremity 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 outcomes

  1. Lymphedema Function, Disability and Health Questionnaire-Lower Extremity (LYMPH ICF-LL) Scale

    Time frame: 5 months

    Evaluates patients' quality of life related to lymphedema.

  2. Visual Analogue Scale (VAS)

    Time frame: 5 months

    VAS: 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".

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2026
First posted
Dec 13, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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