Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND): Prospective Observational Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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, erythema, pain, and impaired limb function. Lymphoedema can have a negative impact on quality of life (QoL) and the impact of lymphoedema on the cancer treatment decision making process is underestimated. A limited number of studies have evaluated the incidence rate of midline and leg lymphoedema after surgery for urogenital cancers and have investigated the prognostic variables. In addition, to the researchers knowledge, no evidence exists regarding which (combination of) clinical measuring methods are most sensitive to detect early lymphoedema at the lower limbs after the treatment of urogenital cancer. Therefore, in this prospective observational study, the epidemiology (i.e. incidence/ prevalence rate and prognostic variables) and the detection methods of lower limb lymphoedema after pelvic lymph node dissection for urogenital cancer will be investigated. Additionally, the epidemiology of nocturia and nocturnal polyuria will be studied (since this information is also missing in literature).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
University Hospitals Leuven, campus Gasthuisberg
RECRUITING
Leuven
Contact Information
Primary
Nele Devoogdt, Prof. Dr.
nele.devoogdt@uzleuven.be
+3216342515
Backup
Charlotte Van Calster, MSc.
charlotte.vancalster@kuleuven.be
Time Frame
Start Date: 2022-01-21
Estimated Completion Date: 2026-11
Participants
Target number of participants: 150
Treatments
transperitoneal pelvic lymph node dissection for treatment of urogenital cancer
patients planned for transperitoneal pelvic lymph node dissection for treatment of urogenital cancer (including prostate or bladder cancer)
Related Therapeutic Areas
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov