Blood and Lymph Conditions

All Conditions

Behaviors and Mental Disorders

Lymphedema

Lymphatic Diseases

Quality of Life

Participants will receive lymphedema education and educational brochures from the researcher on the 2nd day after gynecological cancer surgery.

Routine post-op discharge education is given to patients who undergo gynecological cancer surgery at the institution by nurses on the day of discharge.

On post-op day 2, patients will receive Symptom Management Model-Based Lower Extremity Lymphedema Training. Brochures will be introduced and delivered to the patient.

lymphedema education program

This study aims to examine the effect of lower extremity lymphedema prevention training based on the Symptom Management Model on women undergoing gynecological cancer surgery on lymphedema development, quality of life, and women's self-efficacy. The hypotheses of the study are:

H1a: The quality of life of women who underwent gynecological cancer surgery and received lower extremity lymphedema prevention training based on the Symptom Management Model is statistically significantly higher than the quality of life of women in the control group.

H1b: The self-efficacy levels of women who underwent gynecological cancer surgery and received lower extremity lymphedema prevention training based on the Symptom Management Model are statistically significantly higher than the self-efficacy levels of women in the control group.

H1c: The frequency of experiencing lower extremity lymphedema symptoms of women who underwent gynecological cancer surgery and received lower extremity lymphedema prevention training based on the Symptom Management Model is significantly lower than the frequency of experiencing lower extremity lymphedema symptoms of women in the control group.

Participants will be given training on lower extremity lymphedema. At the end of the study, researchers will evaluate the impact of the training on quality of life, self-efficacy, and lymphedema development.

The incidence of lower extremity lymphedema following gynecological cancer treatment varies depending on the type of gynecological cancer. The prevalence of lymphedema varies between 1-38% in endometrial cancers, 17-81% in cervical cancers, 6-75% in vulvar-vaginal cancers, and 5-21% in ovarian cancers. Studies have shown that the risk of developing lymphedema after gynecological cancer persists in the long term, although the majority of cases occur in the first year. The main factors that increase the risk of developing lower extremity lymphedema are stated as Body Mass Index (BMI), age, The International Federation of Gynecology and Obstetrics (FIGO) cancer stage, lymph node dissection and number of lymph nodes. Lower extremity lymphedema is characterized by symptoms such as unilateral or bilateral swelling, heaviness, pain, itching, numbness, skin changes, infection, etc. These symptoms can seriously affect the patient's quality of life by limiting their daily living activities. Therefore, there is a need for effective interventions to prevent and manage lower extremity lymphedema associated with cancer treatment to improve quality of life and well-being. The training is planned to be structured according to the Symptom Management Model. After gynecological cancer surgery, women's ability to self-diagnose the symptoms they experience related to lymphedema and their responses to these symptoms become part of the management process. In this regard, it is thought that nurse-led education programs positioned in a theoretical framework to prevent lower extremity lymphedema will enable patients to diagnose the early symptoms of lymphedema by improving their knowledge, quality of life, self-efficacy, and reduce the risk of lymphedema. It is anticipated that the model-based nurse-led education program to be developed in this study will be applicable in the clinic and the evidence obtained will guide future research. After obtaining institutional permission, data will be collected by the researcher through a face-to-face interview with women over the age of 18 who meet the inclusion criteria. During this visit, face-to-face information about the research will be given, written consent will be obtained, and data collection tools will be introduced and filled in. The risks of the participants will be determined with the lymphedema risk assessment questionnaire and stratified randomization will be provided accordingly. Research data will be collected with the Socio-demographic Information Form, the Information Form on Cancer Diagnosis, the Lymphedema Risk Assessment Questionnaire, the European Organization for Research and Treatment of Cancer Quality of Life Scale, the 6-Item Self-Efficacy Scale for Chronic Disease Management, Gynecological Cancer Lymphedema Questionnaire and Lower extremity circumference measurement. After data collection, the data will be transferred to the Statistical Package for the Social Sciences (SPSS) 26.0 software package for analysis. The data analysis will include percentages, mean values, standard deviations and chi-square test, independent sample t-test, repeated measures ANOVA test, and the corrected Bonferroni test for advanced analyses.

Feasibility and Effectiveness of Lymphedema Education Program After Gynecological Cancer Surgery

Development and Evaluation of the Effectiveness of Lower Extremity Lymphedema Education Program After Gynecological Cancer Surgery

The scale questions are answered with a "yes" or "no". GCLQ contains 20 questions that evaluate the presence of symptoms over the past four weeks, scored as 0. If a patient scores 20 points on GCLQ, it indicates the presence of all symptoms, while a score of 0 indicates the absence of all symptoms.

Circumference measurements will be taken in the supine position, moving from the medial malleolus to the inguinal region at 5 cm intervals for both lower extremities. The difference between both extremities will be recorded in cm. A difference of 2 cm between sides measured from at least 6 points is considered significant.

The answers are rated from "not at all" (1 point) to "a lot" (4 points). The last two questions (29th and 30th) are related to the general quality of life and ask the patient to evaluate their health and quality of life in the last week on a scale of 1 to 7 (1 being "very bad" and 7 being "very good"). High scores from these questions indicate high quality of life, while low scores indicate low quality of life.; very bad, 7 points; very good).

The scale consists of six items, with the first four measuring behavioral attitude and the last two measuring psychological attitude. Each item is rated on a 10-point scale ranging from "not at all confident" to "completely confident." To obtain the score, the average of all six items is calculated, with higher scores indicating greater self-efficacy.

Koç University

Neoplasms

Skin and Connective Tissue Diseases

Skin Neoplasms

Patients with any type of skin melanoma (at the level of the lower limb), urogenital or gynaecological cancer scheduled for lymph node dissection

screening of patients at risk for developing unilateral or bilateral lower limb lymphedema

clinical assessment

Tessa De Vrieze, Dr.

Lymphedema is a chronic, debilitating disorder characterized by abnormal tissue swelling, adipose deposition and tissue fibrosis, resulting from disruption, blockage, or genetic abnormalities of the lymphatic system. Secondary lymphedema is an acquired lymphedema due to trauma, surgery, radiotherapy or infection among others resulting in a decreased transport capacity of the lymphatic system. This can be combined with an additional load on the lymphatic system due to obesity, venous hypertension or a wound, among others. Advances in oncologic treatment have led to an ever-increasing number of cancer survivors over time. As a result, morbidities related to this treatment (such as secondary lymphedema) are likely to increase too.

Risk factors for the development of LLL after treatment for (gynaecological) cancer are: pelvic and para-aortic lymphadenectomy, the number of pelvic lymph nodes removed, adjuvant radiotherapy, adjuvant chemotherapy, increasing BMI/ BMI ≥25 kg/m², lymphocyst formation, increasing age, increasing time since surgery and insufficient physical activity level.

To the investigators knowledge, no evidence exists regarding which (combination of) measuring methods are most sensitive to detect early lymphedema at the lower limbs after the treatment of cancer. Thresholds for identifying subclinical edema on one or both lower limbs are lacking.

Therefore the investigators want to develop a screening set for patients at risk for developing LLL. Which measurement method (and which criterion) shows the best diagnostic accuracy in screening patients at risk for LLL after cancer treatment? And: What is the added value of combining different measurement methods in terms of diagnostic accuracy?

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 2

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Development of a Screening Set for Patients at Risk for Developing LLL

Sensitivity of reliable and clinical feasible measurement methods (resulted from aim 1: NCT05269264) regarding the screening of patients at risk for developing unilateral or bilateral LLL at 6 weeks, 6, and 12 months post-surgery

Specificity of reliable and clinical feasible measurement methods (resulted from aim 1: NCT05269264) regarding the screening of patients at risk for developing unilateral or bilateral LLL at 6 weeks, 6, and 12 months post-surgery

Diagnostic accuracy of reliable and clinical feasible measurement methods (resulted from aim 1: NCT05269264) regarding the screening of patients at risk for developing unilateral or bilateral LLL at 6 weeks, 6, and 12 months post-surgery

Dependent variable = presence of lower limb lymphoedema Independent variable= Age (years) will be self-reported through interview.

Dependent variable = presence of lower limb lymphoedema Independent variable= 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.

Dependent variable = presence of lower limb lymphoedema Independent variable= Educational level: will be self-reported through interview.

Dependent variable = presence of lower limb lymphoedema Independent variable= baseline Body Mass Index

Dependent variable = presence of lower limb lymphoedema Independent variable= baseline comorbidities

Comorbidities will be reported through a self-developed co-morbidity questionnaire, based on IDEWE questionnaire.

Dependent variable = presence of lower limb lymphoedema Independent variable= Type of cancer Information regarding the type of cancer is collected by exploring the patient's medical file.

Dependent variable = presence of lower limb lymphoedema Independent variable= Tumor stage

Information regarding the tumor stage of is collected by exploring the patient's medical file.

Dependent variable = presence of lower limb lymphoedema Independent variable= Lymph node stage

Information regarding the lymph node stage of is collected by exploring the patient's medical file.

Dependent variable = presence of lower limb lymphoedema Independent variable=Number of positive lymph nodes: is collected through the patient's medical file.

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.

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

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.

Cancer treatment characteristics , including adjuvant radiotherapy are collected; by exploring the patient's medical file.

Calculation of the proportion of patients with leg (or foot) lymphedema, defined as 5.0% or more increase of the leg (or foot) volume in each leg (or foot), at a certain time point, compared to the volumes at baseline; OR patients with a score of at least 5 out of 52 on the detect-OL questionnaire in case it is clearly indicated whether symptoms are present in one or both legs (in order to be able to categorize patients to the "unilateral LLL" or "bilateral LLL" group).

Additionally, the proportion of presence of LLL in patients having received a lymph node dissection due to gynaecological cancer vs. due to urogenital cancer vs. due to skin melanoma will be compared. The distribution of LLL (unilateral vs. bilateral, regions of the lower limb) will be encountered and compared.

Universitaire Ziekenhuizen KU Leuven

KU Leuven

Post-doctoral research fellow and physiotherapist, PhD in Biomedical Sciences (Catholic University of Leuven) and Medical Sciences (University of Antwerp)

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nocturia

Polyuria

Urogenital Neoplasms

Lower Urinary Tract Symptoms

Urological Manifestations

Urination Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

patients planned for transperitoneal pelvic lymph node dissection for treatment of urogenital cancer (including prostate or bladder cancer)

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 patient develops lymphoedema, he/she receives compression stockings.

usual care

Nele Devoogdt, Prof. Dr.

Charlotte Van Calster, MSc.

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).

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.

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

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

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)

Dependent variable = presence of leg lymphoedema/ presence of midline lymphoedema Independent variable= Age (years) will be self-reported through interview.

Baseline fat mass will be measured using Bio-impedance Spectroscopy

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.

Educational level will be self-reported through interview.

Comorbidities will be reported through a self-developed co-morbidity questionnaire, based on IDEWE questionnaire.

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.

Number of positive lymph nodes is collected through the patient's medical file.

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

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

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)

limitations regarding clinical feasibility will be listed and scored (yes/no) for each method.

As "gold standard" to compare the different measurement methods with, every patient will be evaluated individually once by the project's international expert panel, during a monthly (virtual) meeting (2 up to 3h). They will decide whether patients should be labelled as showing 'presence of early signs of lower limb lymphoedema (1)' or 'no signs (0)'. Decision making will occur with an initial assessment of the experts, i.e. in advance of the monthly meeting. Then the project manager will lead the meeting on the basis of the assessments and subsequently conduct a new 'vote'. In case \>2/3 of the experts (= clear majority) decides a patient should receive a diagnosis of lymphoedema, then this patient receives the diagnosis.

outcomes resulting from the measurement method will be compared against the yes/no score regarding clinical presence of LLL from our international expert group

Calculation of the proportion of patients with nocturia/ nocturnal polyuria at a certain time point: baseline, at 6 weeks, 6 and 12 months post-surgery

Age (years) will be self-reported through interview

late-night fluid intake will be assessed through the micturition chart that (during 24 hours, in the week prior to the assessment visit) has to be filled in by the patient before surgery and at 6 weeks, 6 months and 12 months after surgery. The patient has to write down the time, frequency and quantity of urinating during the day and night. The time of drinking a consumption, the amount of a consumption and which consumption also has to be recorded.

late-night caffeine/alcohol use (3 hours before going to bed) will be assessed through the micturition chart that (during 24 hours, in the week prior to the assessment visit) has to be filled in by the patient before surgery and at 6 weeks, 6 months and 12 months after surgery. The patient has to write down the time, frequency and quantity of urinating during the day and night. The time of drinking a consumption, the amount of a consumption and which consumption also has to be recorded.

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.

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.

information regarding the lymph node stage is collected by exploring the patient's medical file.

Surgical complications will be assessed according to the Clavien-Dindo Classification of Surgical Complications. Complications will be determined as 30-day, 90-day or late (\>90 days) complications.

Information about the type of lymph node dissection is collected by exploring the patient's medical file.

Type of lymph node dissection: Limited- Standard- Extended- Super extended

number of lymph nodes removed: by exploring the patient's medical file.

Cancer treatment characteristics , including radiotherapy are collected; by exploring the patient's medical file.

Cancer treatment characteristics are collected, including the presence of postoperative drain, are collected by exploring the patient's medical file.

The presence of leg lymphoedema (defined as 5.0% or more increase of the leg volume) and midline lymphoedema (defined as 20% or more increase of the baseline water content at the prepubic region)

It is a 12-week, middle-level, home-based, anti-resistance exercise. Exercise was recommended 1-2 times per day for 15-20 mins per session.

home-based anti-resistance exercise

The leaflet of the lymphedema self-care, including skin care and manual lymphatic drainage

usually care

Yu-Yun Hsu

Background:

The incidence of lower limb lymphedema (LLL) after gynecological cancer surgery with lymphadenectomy is about 10-46%. Lower limb lymphedema results in limited physical mobility and reduced patients' quality of life. A hospital -based complete decongestive therapy has been recommended to patients with LLL, including exercise, manual lymphatic drainage, compression therapy, and skin care. However, the inconvenience of the hospital-based rehabilitation program limit the availability for those patients LLL. Home-based exercise program may be feasible instead of the hospital-based program. Few studies have evaluated the effectiveness of the home-based lower extremity exercise on reliving LLL and improving quality of life in patients with LLL.

Research Purposes:

The main purpose of the study is to evaluate the effectiveness of a home-based exercise program for relieving lower extremity lymphedema, including circumference measurement, bioimpedance spectroscopy (BIS), lower limb muscle strength, quality of life related to cancer \& LLL, and fatigue.

Methods:

This study is a two- year project with a single-blind randomized clinical trial. The participants are women with gynecological cancer surgery, aged of 20-75 years and currently have lower extremity lymphedema. A sample of 76 participants will be stratified randomly assigned to an experimental group or a control group. The experimental group is to carry out a home-based anti-resistance exercise with elastic band other than a routine care of complex decongestive physiotherapy; while the control group is to carry out a routine care of complex decongestive physiotherapy. The home-based program is a 12-week exercise program. Data collections will be conducted before exercise (Baseline), during exercise (second months), and exercise program after completion. Measures includes (1) Physical examination: limb leg circumference measurement, bioimpedance spectroscopy (BIS), lower limb muscle strength, (2) Questionnaires: Functional status of lymphatic edema of LLL, fatigue, and EORTC-QLQ-C30.

Anticipated Outcomes:

Findings from this study could provide a reference of home-based exercise guideline and be integrated into the care of activities for women following gynecological surgery with LLL.

The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema Among Gynecological Cancer

Measuring by Bioelectrical Impedance Spectroscopy (BIS)- InBody S10

Measuring by Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL). It is a 28-item, 0(no problem) to 10(very severe) questionnaire.

Measuring by Chinese Lee Fatigue Scale Short Form (C-LESSF). It is a 7-item, from 0(no fatigue) to 10(very fatigue) questionnaire.

Measuring by EORTC QLQ C30. It is a 30-item, from 0(no problem) to 10(very severe) questionnaire.

National Cheng Kung University

Professor

Skin care, exercise and compression stocking:

The patient has to wear custom-made compression thigh stocking(s) in case of unilateral/ bilateral swelling of the leg and has to wear a bermuda in case of swelling of the midline region. The patient continues the skin care and continues/ restarts exercise therapy with the home physical therapist 2 times a week. Frequency of exercises is gradually decreased: M1-3 2x/w, M4-6 1x/w, M7-9 1x/M; M10-12 only self-exercises.

Usual care + manual lymph drainage. Manual lymph drainage is performed by the home physical therapist. Every session lasts for 30 minutes.

Frequency of manual lymph drainage is gradually decreased: M1-3 2x/w, M4-6 1x/w, M7-9 1x/M; M10-12 only self-MLD.

Manual lymph drainage

skin care, exercise and compression stocking

Usual care

After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Lymphoedema is the result of a dysfunction in the lymphatic system and is characterized by excessive retention of lymphatic fluid in the interstitial compartment, adipose deposition and chronic tissue inflammation resulting in fibrosis. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function.

The added value of manual lymph drainage, applied in patients with mild (early) lower limb lymphoedema and in addition to skin care, exercises and a compression stocking, has never been investigated.

Therefore, the objective of this randomised controlled pilot trial is to investigate the feasibility of a trial about the added value of manual lymph drainage (to skin care, exercises and wearing compression stocking) in patients with mild (early) lower limb lymphoedema. In fact, the investigators want to determine the sample size for a trial investigating the effectiveness of MLD and want to investigate the feasibility of the study design.

Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection for Urogenital Cancer

Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND) for Urogenital Cancer: Randomised Controlled Trial (Pilot)

Lymphoedema-specific quality of life will be evaluated using the Lymph-ICL-LL questionnaire: The Lymph-ICF-LL is a descriptive, evaluative tool containing 28 questions about impairments in function, activity limitations, and participation restrictions in patients with lower limb lymphoedema. The questionnaire has 5 domains: physical function, mental function, general tasks/household activities, mobility activities, and life domains/social life.

Volume measurements will be done at midline, leg and foot. Volume midline: circumference at the level of the hip and distance navel - pubic bone, with tapeline.

Volume leg: circumference measurements in sitting position, with knee extension, foot supported by chair; reference point is the upper border of the patella and every 4cm up to the groin and to the ankle, with perimeter Volume foot: figure of 8 method: in sitting position, with knee extension, foot supported by chair and relaxed; with tapeline; make the figure 8 between the distal part of medial and lateral malleolus and the proximal border of metatarsal I and V

Health-related quality of life will be assessed with the EuroQol EQ-5D-5L (questionnaire).

The EQ-5D, developed by the EuroQol Group, is a generic HRQoL instrument commonly used for indirect utility measurement. It is a descriptive system for health states, encompassing 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), combined with a visual analogue scale ranging from "worst imaginable health state" to "best imaginable health state". Each health dimension has 5 levels of severity (EQ-5D-5L;5L: no problems, slight problems, moderate problems, severe problems,extreme problems /unable to).

Each EQ-5D health state is labelled by a code, e.g. 21531, where each digit represents the severity level of a dimension. By convention, the order of dimensions is mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Physical activity 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.

Water content in the leg and midline region will be measured using the MoistureMeterD Compact.

Extracellular fluid in the lower limb will be measured with bio-impedance spectroscopy.

Body weight will be measured with an electronic balance

Number of infection episodes during the previous 6 months is questioned

Number of patients accepting to participate in the randomized controlled pilot trial

If the participant is randomised to the intervention group with manual lymph drainage, information is collected regarding the type of lymph drainage, the number of sessions and the duration of one session.

Difficulties concerning the intervention will be registered

The number of drop-outs in both the experimental as the control group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility and Effectiveness of Lymphedema Education Program After Gynecological Cancer Surgery	NCT06251856	Lower Extremity...	lymphedema educ...	18 Years -	Koç University
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 2	NCT05421377	Lower Limb Lymp...	clinical assess...	18 Years -	KU Leuven
Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer	NCT05300308	Urogenital Canc... Lower Limb Lymp... Nocturia Nocturnal Polyu...	usual care	18 Years -	Universitaire Ziekenhuizen KU Leuven
The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema Among Gynecological Cancer	NCT05003973	Gynecological C... Lower Limb Lymp...	home-based anti... usually care	20 Years - 75 Years	National Cheng Kung University
Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection for Urogenital Cancer	NCT05266157	Lower Limb Lymp... Urogenital Canc...	Manual lymph dr... Usual care	18 Years -	Universitaire Ziekenhuizen KU Leuven

Spots Global Cancer Trial Database for lower limb lymphedema