Comparing physiotherapy methods for lymphedema after surgery
Effect of Complex Decongestive Physiotherapy Applied After Lymphovenous Anastomosis Surgery on Extremity Volume, Quality of Life and Patient Satisfaction (Randomized Controlled Study)
This study is testing if a special type of physiotherapy helps people with lymphedema feel better after surgery compared to those who only get the therapy without surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Necmettin Erbakan University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Konya and 1 other locations) |
| Trial ID | NCT06167993 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Complex Decongestive Physiotherapy (CDP) in patients with lymphedema who have undergone lymphovenous anastomosis surgery compared to those who have not had surgery. A total of 26 volunteers will be randomly assigned to receive either CDP after surgery or CDP alone. The study will assess extremity volume, quality of life, and patient satisfaction through various measurements and questionnaires. The treatment will involve a comprehensive approach including manual lymph drainage, skin care, compression therapy, and therapeutic exercises over a 20-session period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with unilateral stage 2 or 3 lymphedema who have undergone lymphovenous anastomosis surgery at least one month prior.
Not a fit: Patients with bilateral lymphedema, systemic disease-related edema, or those who have had LVA surgery more than 1.5 months ago may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and quality of life for patients suffering from lymphedema.
How similar studies have performed: While the approach of using CDP is established, the specific comparison of post-surgery outcomes with and without CDP is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Konya and 1 other locations
- Bilsev İnce — Konya, Turkey (Recruiting)
- Hanife Dogan — Konya, Turkey (Recruiting)
Study contacts
- Study coordinator: Hanife Dogan, Assoc.Prof.
- Email: hanife_dogan@yahoo.com.tr
- Phone: +905075346142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.