Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: usual care.
- Who it may be relevant to
- Registry conditions: Urogenital Cancer, Lower Limb Lymphedema, Nocturia, Nocturnal Polyuria. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND): Prospective Observational Study
Overview
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).
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 lymphoedema or acquired lymphoedema. In 2018, 11 645 patients in Belgium were diagnosed with urogenital cancer cancer, including prostate and bladder cancer. A possible treatment consists of prostatectomy or cystectomy in combination with transperitoneal pelvic lymph node dissection. Patients who undergo treatment for cancer may develop lower limb lymphoedema or lymphoedema at midline. To the researchers knowledge, investigation of incidence of lower limb lymphoedema (LLL) is limited. Also, the prognostic variables for the development of LLL are unknown. Furthermore, no scientific evidence consists regarding which (combination of) clinical measurement methods are most sensitive to detect early LLL after transperitoneal pelvic lymph node dissection. Thresholds to identify subclinical lymphoedema in one or both legs are lacking. Besides lymphoedema in the lower limbs, treatment for cancer also often results in urinary problems. Especially urinary stress incontinence has been described in literature. However, in clinical practice, it is clear that prostatectomy is often associated with other urinary complications, as nocturia and nocturnal polyuria. To the researchers knowledge, there are no trials investigating the prognostic variables for the development of nocturia/ nocturnal polyuria after transperitoneal pelvic lymph node dissection for urogenital cancer.
Therefore, the researchers will execute a trial investigating the epidemiology (i. e incidence, prevalence and prognostic variables), detection methods and the feasibility of a trial about the early treatment of LLL after transperitoneal pelvic lymph node dissection for urogenital cancer. The epidemiology of LLL, nocturia and nocturnal polyuria will be investigated.
Participants: 150 patients undergoing a transperitoneal pelvic lymph node dissection for urogenital cancer will be included. These participants will be followed-up from baseline (pre-surgery) until 1 year post-surgery. All participants are evaluated at the University Hospitals Leuven, campus Gasthuisberg.
Procedure: The potential participant will be screened first to see if the patients meets the inclusion criteria. After signing the informed consent form, the participant will be followed in the prospective observational trial. The duration of the prospective observational trial is 2 years. Participants can be included until 1 year after the start of the trial.
Evaluation: There will be clinical evaluation of lymphoedema as well as treatment for lymphoedema. Participants in the prospective observational trial will be evaluated 4 times: baseline (pre-surgery), 6 weeks, 6 and 12 months post-surgery.
Treatment: All participants in the prospective observational trial receive standard of care. This consists out of information, skincare and exercises. The information about lymphoedema and its prevention is given by the physical therapist of the department of urology during the hospital stay. Skincare consists of daily moisturizer of legs and feet and prevention and care of wounds. The exercises are supervised by the home physical therapist. The frequency of the session at the physical therapist are gradually decreased.
Interventions
- Other usual care
The 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
Primary outcome measures
- 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 [Time frame: 6 weeks post-surgery]
- 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 [Time frame: 6 months post-surgery]
- 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 [Time frame: 12 months post-surgery]
- Prognostic value of 'baseline age' for the development of lower limb lymphoedema at 12 months post-surgery. [Time frame: 12 months post-surgery]
- Prognostic value of ' Baseline fat mass' for the development of lower limb lymphoedema at 12 months post-surgery. [Time frame: 12 months post-surgery]
- Prognostic value of ' Baseline physical activity level' for the development of lower limb lymphoedema at 12 months post-surgery. [Time frame: 12 months post-surgery]
- Prognostic value of ' Baseline educational level' for the development of lower limb lymphoedema at 12 months post-surgery. [Time frame: 12 months post-surgery]
- Prognostic value of ' baseline comorbidities' for the development of lower limb lymphoedema at 12 months post-surgery. [Time frame: 12 months post-surgery]
- Prognostic value of 'type of cancer' for the development of lower limb lymphoedema at 12 months post-surgery. [Time frame: 12 months post-surgery]
- Prognostic value of 'Tumor stage' for the development of lower limb lymphoedema at 12 months post-surgery. [Time frame: 12 months post-surgery]
Secondary outcome measures (12)
- Point prevalence rate of lower limb lymphoedema (i.e. number of patients with lower limb lymphoedema) [Time frame: up to 12 months post-surgery]
- Reliability of detection lower limb lymphoedema developing after the treatment of urogenital cancer [Time frame: 12 months post-surgery]
- Time efficiency of lymphoedema measurements [Time frame: 12 months post-surgery]
- Presence of limitations of lymphoedema measurements [Time frame: 12 months post-surgery]
- Validity of lymphoedema measurements [Time frame: 12 months post-surgery]
- diagnostic accuracy of the screening methods for lower limb lymphoedema [Time frame: 12 months post-surgery]
- Point prevalence rate of nocturia and nocturnal polyuria [Time frame: up to 12 months post-surgery]
- Prognostic value of 'baseline age' for the development of nocturia and nocturnal polyuria [Time frame: 12 months]
- Prognostic value of 'late-night fluid intake' for the development of nocturia and nocturnal polyuria [Time frame: 12 months]
- Prognostic value of 'late-night caffeine/alcohol use (3 hours before going to bed)' for the development of nocturia and nocturnal polyuria [Time frame: 12 months]
- Prognostic value of 'comorbidities' for the development of nocturia and nocturnal polyuria [Time frame: 12 months]
- Prognostic value of 'baseline fat mass' for the development of nocturia and nocturnal polyuria [Time frame: 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- University Hospitals Leuven, campus Gasthuisberg — Leuven
Identifiers
NCT: NCT05300308 · s66072