Impact of Lymphoedema and Urinary Issues After Cancer Surgery
Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND): Prospective Observational Study
This study looks at how common swelling in the legs and urinary problems are after cancer surgery to see if certain tests can help catch these issues early and improve life for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Flanders) |
| Trial ID | NCT05300308 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the incidence and prognostic variables of lower limb lymphoedema and urinary complications such as nocturia and nocturnal polyuria in patients who have undergone pelvic lymph node dissection for urogenital cancers. It aims to identify the most sensitive clinical measurement methods for early detection of lymphoedema and to understand the relationship between cancer treatment and urinary issues. By collecting data on these conditions, the study seeks to improve patient care and quality of life post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with non-metastatic urogenital cancer who are scheduled for pelvic lymph node dissection.
Not a fit: Patients with evidence of metastatic disease or those with a history of pelvic lymph node dissection or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better detection and management of lymphoedema and urinary complications, ultimately improving the quality of life for patients after urogenital cancer treatment.
How similar studies have performed: While there is limited research on the incidence of lymphoedema after urogenital cancer treatment, this study aims to fill a gap in knowledge, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Leuven, Flanders
- University Hospitals Leuven, campus Gasthuisberg — Leuven, Flanders, Belgium (Recruiting)
Study contacts
- Principal investigator: Nele Devoogdt, Prof. Dr. — UZ Leuven
- Study coordinator: Nele Devoogdt, Prof. Dr.
- Email: nele.devoogdt@uzleuven.be
- Phone: +3216342515
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.