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
This trial does not accept healthy volunteersQualifiers
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 population
patients planned for transperitoneal pelvic lymph node dissection for treatment of urogenital cancer (including prostate or bladder cancer)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
usual care
Other interventionThe information about lymphoedema and its prevention is given during the hospital stay by the physical therapist of the department of urology. Skincare consists of daily skin moisturizer of feet and legs and prevention and care of wounds. Active exercises are performed to gain endurance and muscle strength after surgery and to stimulate the blood and lymph circulation. The exercises are supervised by the home physical therapist. Frequency of the supervised exercises is gradually decreased. If a patient develops lymphoedema, he/she receives compression stockings.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: transperitoneal pelvic lymph node dissection for treatment of urogenital cancer1 intervention
Trial outcomes
Primary outcomes
1
Cumulative incidence rate of lower limb lymphoedema after urogenital cancer (i.e. number of patients with newly diagnosed lower limb lymphoedema) 6 weeks post-surgery
Calculation of the proportion of patients who developed leg lymphoedema during a certain time interval (defined as 5.0% or more increase of the leg volume) and calculation of the proportion of patients who developed midline lymphoedema during a certain time interval (defined as 20% or more increase of the baseline water content at the prepubic region)
Time frame
6 weeks post-surgery2
Cumulative incidence rate of lower limb lymphoedema after urogenital cancer (i.e. number of patients with newly diagnosed lower limb lymphoedema) 6 months post-surgery
Calculation of the proportion of patients who developed leg lymphoedema during a certain time interval (defined as 5.0% or more increase of the leg volume) and calculation of the proportion of patients who developed midline lymphoedema during a certain time interval (defined as 20% or more increase of the baseline water content at the prepubic region)
Time frame
6 months post-surgery3
Cumulative incidence rate of lower limb lymphoedema after urogenital cancer (i.e. number of patients with newly diagnosed lower limb lymphoedema) 12 months post-surgery
Calculation of the proportion of patients who developed leg lymphoedema during a certain time interval (defined as 5.0% or more increase of the leg volume) and calculation of the proportion of patients who developed midline lymphoedema during a certain time interval (defined as 20% or more increase of the baseline water content at the prepubic region)
Time frame
12 months post-surgery4
Prognostic value of 'baseline age' for the development of lower limb lymphoedema at 12 months post-surgery.
Dependent variable = presence of leg lymphoedema/ presence of midline lymphoedema Independent variable= Age (years) will be self-reported through interview.
Time frame
12 months post-surgerySecondary outcomes
1
Point prevalence rate of lower limb lymphoedema (i.e. number of patients with lower limb lymphoedema)
Calculation of the proportion of patients with leg lymphoedema at a certain time point (defined as 5.0% or more increase of the leg volume) and calculation of the proportion of patients with midline lymphoedema at a certain time point (defined as 20% or more increase of the baseline water content at the prepubic region): 6 weeks, 6 and 12 months post-surgery
Time frame
up to 12 months post-surgery2
Reliability of detection lower limb lymphoedema developing after the treatment of urogenital cancer
To investigate reliability, all participants with lower limb lymphoedema at 12 months post-surgery will be evaluated three times with each evaluation method: intra and interrater reliability will be determined
Time frame
12 months post-surgery3
Time efficiency of lymphoedema measurements
To determine feasibility of each method, time efficiency will be examined for each method: setup time (time needed to prepare the measurement), execution time ( time needed for a bilaterally execution of the measurement) and total time (required for the setup and the execution of the measurement) (min, sec)
Time frame
12 months post-surgery4
Presence of limitations of lymphoedema measurements
limitations regarding clinical feasibility will be listed and scored (yes/no) for each method.
Time frame
12 months post-surgerySponsors and contacts
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Source ClinicalTrials.gov