Complex Decongestive Physiotherapy Applied After Lymphovenous Anastomosis Surgery

NCT ID: NCT06167993

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2024-06-15

Brief Summary

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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

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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.

Conditions

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Lymphedema Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Group receiving CDP in patients who underwent LVA

LVA: Group that underwent lymphovenous anastomosis surgery and CDP applied groups CDP:Complex Decongestive Physiotherapy

Group Type EXPERIMENTAL

Complex Decongestive Physiotherapy

Intervention Type BEHAVIORAL

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

Group receiving CDP after lymphedema

Only CDP applied groups

Group Type ACTIVE_COMPARATOR

Complex Decongestive Physiotherapy

Intervention Type BEHAVIORAL

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

Interventions

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Complex Decongestive Physiotherapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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hanife dogan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bilsev İnce

Konya, , Turkey (Türkiye)

Site Status RECRUITING

Hanife Dogan

Konya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hanife Dogan, Assoc.Prof.

Role: CONTACT

+905075346142

Bilsev İnce, Prof.

Role: CONTACT

+905552776488

Facility Contacts

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Bilsev İnce

Role: primary

+905552776488

Hanife Dogan

Role: primary

+905075346142

Other Identifiers

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hdogan

Identifier Type: -

Identifier Source: org_study_id

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