Complex Decongestive Physiotherapy Applied After Lymphovenous Anastomosis Surgery

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167993
• Other study ID #: hdogan
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2024
• Source: Necmettin Erbakan University
• Contact: Hanife Dogan, Assoc.Prof.
• Phone: +905075346142
• Email: hanife_dogan[@]yahoo.com.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: June 15, 2024
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Lymphedema

Intervention

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

Locations

Country	Name	City	State
Turkey	Bilsev Ince	Konya
Turkey	Hanife Dogan	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tape Measure	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.	5 months
Secondary	Lymphedema Function, Disability and Health Questionnaire-Lower Extremity (LYMPH ICF-LL) Scale	Evaluates patients' quality of life related to lymphedema.	5 months
Secondary	Visual Analogue Scale (VAS)	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".	5 months