LymphedemaNCT06167993
Complex Decongestive Physiotherapy Applied After Lymphovenous Anastomosis Surgery
A study testing Complex Decongestive Physiotherapy in people with Lymphedema and Cancer, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lymphedema, Cancer
- What is being tested?
- Complex Decongestive Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 21 Aug 2023to 4 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effect of Complex Decongestive Physiotherapy Applied After Lymphovenous Anastomosis Surgery on Extremity Volume, Quality of Life and Patient Satisfaction (Randomized Controlled Study)
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?
Read the 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.
- Conditions
- Lymphedema, Cancer
- Being tested
- Complex Decongestive Physiotherapy
- Medical subject headings
- Lymphedema, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex Decongestive PhysiotherapyBehavioural
Complex Decongestive Physiotherapy; It consists of manual therapy, skin care, compression therapy and therapeutic exercise.
| Study group | Role | What they receive |
|---|---|---|
| Group receiving CDP in patients who underwent LVA | Experimental | LVA: Group that underwent lymphovenous anastomosis surgery and CDP applied groups CDP:Complex Decongestive Physiotherapy Receives: Behavioral: Complex Decongestive Physiotherapy |
| Group receiving CDP after lymphedema | Active comparator | Only CDP applied groups Receives: Behavioral: Complex Decongestive Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (2)
Lymphedema Function, Disability and Health Questionnaire-Lower Extremity (LYMPH ICF-LL) Scale
Evaluates patients' quality of life related to lymphedema.
Measured: 5 months
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".
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start21 Aug 2023
- Primary completion21 Aug 2023
- Study completion4 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanife dogan, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167993
- Sponsor's protocol ID
- hdogan
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Complex Decongestive Physiotherapy Applied After Lymphovenous Anastomosis Surgery on Extremity Volume, Quality of Life and Patient Satisfaction (Randomized Controlled Study)
- ClinicalTrials.gov ID
- NCT06167993
- Acronym / sponsor ID
- hdogan
- Conditions
- Lymphedema, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 4 Apr 2026 (actual)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group receiving CDP in patients who underwent LVA | Experimental | Behavioral: Complex Decongestive PhysiotherapyLVA: Group that underwent lymphovenous anastomosis surgery and CDP applied groups CDP:Complex Decongestive Physiotherapy |
| Group receiving CDP after lymphedema | Active comparator | Behavioral: Complex Decongestive PhysiotherapyOnly CDP applied groups |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex Decongestive PhysiotherapyComplex Decongestive Physiotherapy; It consists of manual therapy, skin care, compression therapy and therapeutic exercise. | Behavioural | Group receiving CDP after lymphedema, Group receiving CDP in patients who underwent LVA |
Primary outcome
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.
2 secondary outcomes
Lymphedema Function, Disability and Health Questionnaire-Lower Extremity (LYMPH ICF-LL) Scale
Time frame: 5 months
Visual Analogue Scale (VAS)
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex Decongestive Physiotherapy in people with Lymphedema and Cancer, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tape Measure (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.