Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND): Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Prognostic value of 'type of cancer' for the development of lower limb lymphoedema at 12 months post-surgery.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Prognostic value of 'type of cancer' for the development of lower limb lymphoedema at 12 months post-surgery.
时间窗: 12 months post-surgery
Information regarding the type of urogenital cancer (prostate versus bladder) and the stage of the urogenital cancer is collected (i.e. histological subtype, PSA (if PCa), pTN stage, ISUP grade group (if PA); by exploring the patient's medical file.
Prognostic value of 'Adjuvant Radiotherapy' for the development of lower limb lymphoedema at 12 months post-surgery.
时间窗: 12 months post-surgery
Cancer treatment characteristics , including adjuvant radiotherapy are collected; by exploring the patient's medical file.
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
时间窗: 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)
Prognostic value of 'Tumor stage' for the development of lower limb lymphoedema at 12 months post-surgery.
时间窗: 12 months post-surgery
Information regarding the type of urogenital cancer (prostate versus bladder) and the stage of the urogenital cancer is collected (i.e. histological subtype, PSA (if PCa), pTN stage, ISUP grade group (if PA); by exploring the patient's medical file.
Prognostic value of 'number of positive lymph nodes' for the development of lower limb lymphoedema at 12 months post-surgery.
时间窗: 12 months post-surgery
Number of positive lymph nodes is collected through the patient's medical file.
Prognostic value of 'type of lymph node dissection' for the development of lower limb lymphoedema at 12 months post-surgery.
时间窗: 12 months post-surgery
Cancer treatment characteristics are collected (i.e. type of surgery, type of lymph node dissection, number of lymph nodes removed, presence of postoperative drain, number of positive lymph nodes, adjuvant therapies; by exploring the patient's medical file. Type of lymph node dissection: Limited- Standard- Extended- Super extended
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
时间窗: 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)
Prognostic value of ' Baseline fat mass' for the development of lower limb lymphoedema at 12 months post-surgery.
时间窗: 12 months post-surgery
Baseline fat mass will be measured using Bio-impedance Spectroscopy
Prognostic value of ' baseline comorbidities' for the development of lower limb lymphoedema at 12 months post-surgery.
时间窗: 12 months post-surgery
Comorbidities will be reported through a self-developed co-morbidity questionnaire, based on IDEWE questionnaire.
Prognostic value of 'number of lymph nodes removed' for the development of lower limb lymphoedema at 12 months post-surgery.
时间窗: 12 months post-surgery
Cancer treatment characteristics are collected (i.e. type of surgery, type of lymph node dissection, number of lymph nodes removed, presence of postoperative drain, number of positive lymph nodes, adjuvant therapies; by exploring the patient's medical file.
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
时间窗: 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)
Prognostic value of 'baseline age' for the development of lower limb lymphoedema at 12 months post-surgery.
时间窗: 12 months post-surgery
Dependent variable = presence of leg lymphoedema/ presence of midline lymphoedema Independent variable= Age (years) will be self-reported through interview.
Prognostic value of ' Baseline physical activity level' for the development of lower limb lymphoedema at 12 months post-surgery.
时间窗: 12 months post-surgery
Baseline physical activity level will be assessed with the International Physical Activity Questionnaire (IPAQ). The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.
Prognostic value of ' Baseline educational level' for the development of lower limb lymphoedema at 12 months post-surgery.
时间窗: 12 months post-surgery
Educational level will be self-reported through interview.
Prognostic value of 'Lymph node stage' for the development of lower limb lymphoedema at 12 months post-surgery.
时间窗: 12 months post-surgery
Information regarding the type of urogenital cancer (prostate versus bladder) and the stage of the urogenital cancer is collected (i.e. histological subtype, PSA (if PCa), pTN stage, ISUP grade group (if PA); by exploring the patient's medical file.
Prognostic value of 'postoperative complications' for the development of lower limb lymphoedema at 12 months post-surgery.
时间窗: 12 months post-surgery
Information regarding the complications related to the surgery as well as adjuvant therapies is collected. Surgical complications will be assessed according to the Clavien-Dindo Classification of Surgical Complications.
次要结局
- Reliability of detection lower limb lymphoedema developing after the treatment of urogenital cancer(12 months post-surgery)
- Point prevalence rate of lower limb lymphoedema (i.e. number of patients with lower limb lymphoedema)(up to 12 months post-surgery)
- Time efficiency of lymphoedema measurements(12 months post-surgery)
- Prognostic value of 'baseline age' for the development of nocturia and nocturnal polyuria(12 months)
- Validity of lymphoedema measurements(12 months post-surgery)
- Prognostic value of 'late-night caffeine/alcohol use (3 hours before going to bed)' for the development of nocturia and nocturnal polyuria(12 months)
- Prognostic value of 'tumor stage' for the development of nocturia and nocturnal polyuria(12 months)
- Prognostic value of 'number of positive lymph nodes' for the development of nocturia and nocturnal polyuria(12 months)
- Prognostic value of 'postoperative complications' for the development of nocturia and nocturnal polyuria(12 months)
- Prognostic value of 'type of lymph node dissection' for the development of nocturia and nocturnal polyuria(12 months)
- Prognostic value of 'late-night fluid intake' for the development of nocturia and nocturnal polyuria(12 months)
- Prognostic value of 'baseline physical activity' for the development of nocturia and nocturnal polyuria(12 months)
- Prognostic value of 'presence of postoperative drain' for the development of nocturia and nocturnal polyuria(12 months)
- Presence of limitations of lymphoedema measurements(12 months post-surgery)
- diagnostic accuracy of the screening methods for lower limb lymphoedema(12 months post-surgery)
- Prognostic value of 'baseline fat mass' for the development of nocturia and nocturnal polyuria(12 months)
- Point prevalence rate of nocturia and nocturnal polyuria(up to 12 months post-surgery)
- Prognostic value of 'baseline educational level' for the development of nocturia and nocturnal polyuria(12 months)
- Prognostic value of 'lymph node stage' for the development of nocturia and nocturnal polyuria(12 months)
- Prognostic value of 'number of lymph nodes removed' for the development of nocturia and nocturnal polyuria(12 months)
- Prognostic value of 'comorbidities' for the development of nocturia and nocturnal polyuria(12 months)
- Prognostic value of 'type of cancer' for the development of nocturia and nocturnal polyuria(12 months)
- Prognostic value of 'radiotherapy' for the development of nocturia and nocturnal polyuria(12 months)
- Prognostic value of 'presence of lymphoedema' for the development of nocturia and nocturnal polyuria(12 months)