Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection for Urogenital Cancer
NCT05266157 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-06-28
Summary
After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Lymphoedema is the result of a dysfunction in the lymphatic system and is characterized by excessive retention of lymphatic fluid in the interstitial compartment, adipose deposition and chronic tissue inflammation resulting in fibrosis. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function.
The added value of manual lymph drainage, applied in patients with mild (early) lower limb lymphoedema and in addition to skin care, exercises and a compression stocking, has never been investigated.
Therefore, the objective of this randomised controlled pilot trial is to investigate the feasibility of a trial about the added value of manual lymph drainage (to skin care, exercises and wearing compression stocking) in patients with mild (early) lower limb lymphoedema. In fact, the investigators want to determine the sample size for a trial investigating the effectiveness of MLD and want to investigate the feasibility of the study design.
Conditions
- Lower Limb Lymphedema
- Urogenital Cancer
Interventions
- OTHER
-
Manual lymph drainage
Manual lymph drainage
- OTHER
-
Usual care
skin care, exercise and compression stocking
Sponsors & Collaborators
-
Universitaire Ziekenhuizen KU Leuven
lead OTHER
Principal Investigators
-
Nele Devoogdt, Prof. Dr. · Universitaire Ziekenhuizen KU Leuven
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-21
- Primary Completion
- 2024-09-01
- Completion
- 2024-09-01
Countries
- Belgium
Study Locations
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