Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • usual care

Treatment groups

150 Participants
are divided into 1 treatment group