Status:
RECRUITING
Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Urogenital Cancer
Lower Limb Lymphedema
Eligibility:
All Genders
18+ years
Brief Summary
After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythe...
Detailed Description
Lymphoedema is caused by malfunction of the lymphatic system whether or not in combination with extra load on this system. Some patients develop lymphoedema after treatment for cancer: secondary lymph...
Eligibility Criteria
Inclusion
- Non-metastatic urogenital cancer (i.e. prostate cancer or bladder cancer)
- Planned transperitoneal pelvic lymph node dissection or salvage lymph node dissection
- Salvage lymph node dissection
- Before inclusion, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion
- Radiological evidence of metastatic disease based on pelvic CT/MRI and bone scan
- Clinical signs of chronic venous insufficiency (CEAP C3-C6)
- History of lymph node dissection/ radiotherapy at the level of the pelvis or groin
Key Trial Info
Start Date :
January 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05300308
Start Date
January 21 2022
End Date
November 1 2026
Last Update
July 11 2025
Active Locations (1)
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1
University Hospitals Leuven, campus Gasthuisberg
Leuven, Flanders, Belgium, 3000