Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Respiratory Aspiration

Lymphedema

Lymphatic Diseases

CDP program consisting of 4 parameters will be applied to this group. These parameters are MLD, Skin care, Multi-layer bandage application and decongestive exercises. In addition, the Placebo Facial Release technique will be performed by keeping the physiotherapist's hand in contact with the patient's abdominal region without applying any pressure and tension during the breathing exercises. Participants will be treated for a total of 3 weeks, 5 days a week. Each treatment session will last 45 minutes.

CDP program consisting of 4 parameters will be applied to this group. These parameters are MLD, Skin care, Multi-layer bandage application and decongestive exercises. In addition, Multidimensional Diaphragmatic Breathing Exercises and Facial Release technique will be applied. These two treatments consist of these sub-exercises. These; Mechanical nose opening techniques, Intermittent Sniffing exercise, Diaphragm Awareness and Exercise Short Protocol, Thorax mobilization exercises, Myofascial diaphragm release techniques, Myofascial release exercises and postures and, Pelvic floor myofascial release postures.

Participants will be treated for a total of 3 weeks, 5 days a week. Each treatment session will last 45 minutes.

Complete or complex decongestive physiotherapy (CDP) is a treatment for lymphedema, a condition in which excess fluid (lymph) collects in a part of the body. Damage to the lymph nodes or vessels, or a blockage leading to chronic swelling, usually causes lymphedema.

Complex Decongestive Physiotherapy

Diaphragmatic breathing is an exercising technique to help strengthen your diaphragm and fill your lungs with air more efficiently.

Multidimensional Diaphragmatic Breathing Exercises

Fascial release is a manual therapy method that is applied holistically to the muscles and surrounding fascia through mechanical stimulation. It is a comprehensive approach to the evaluation and treatment of the muscular and fascia system in the body.

Facial Release Technique

Ayça Evkaya Acar, MSc

Nilüfer Kablan, Asst. Prof.

The aim of this study is to determine the effect of multidimensional breathing exercises and fascial release techniques performed in addition to the conventional treatment program on the treatment of lymphatic fluid in women with lower extremity lymphedema due to gynecological cancer treatment, and the reflection of these practices on the functional level, sleep and quality of life.

Secondary lower extremity lymphedema is frequently encountered after gynecological (endometrial, cervical, ovarian, vulvar/vaginal) cancer treatments. Lymphedema is a non-curative disease that is characterized by fluid and protein accumulation in the subcutaneous space. In the later stages, secondary skin changes and ulcers accompany, but it can cause complications such as fatigue, decrease in physical activity level, sleep and sexual dysfunction, and decrease in quality of life. Depending on the damaged area of the lymphatic system, it is exposed unilaterally or bilaterally, and in some cases, it also covers the lower body quarter and genital area. Chemotherapy and radiotherapy applications are a factor in its emergence. However, it has been reported that the main cause of lymphedema associated with gynecological cancer is the intervention in abdominal lymph nodes (para-aortic/-caval/external iliac/obturator/internal iliac/common iliac/presacral) and inguinal lymph nodes, especially pelvic. Studies have shown that lymph node interventions disrupt lymphatic flow and the risk of lymphedema exposure increases in direct proportion to the number of lymph nodes removed.

The superficial lymphatic drainage of the lower extremity occurs through lymphatic collectors, mainly to the inguinal and to a lesser extent, to the popliteal region lymph nodes. Lymph fluid passing through the deep lymphatic system from these regions, follows the pelvic lymph nodes, lumbar lymph nodes, lumbar trunks, cisterna chyli, and ductus thoracicus, respectively, and discharges into the venous system from the left venous aspect. Because of its passage through the abdominal and thoracic cavities, lower extremity lymphatic drainage is affected by thoracolumbal diaphragmatic motility. It has been reported that diaphragmatic movement creates positive pressure in the abdominal region during inspiration, providing the filling of lymph collectors/nodules (also venous system) in this region. On the other hand, negative pressure in the thoracic region during expiration results in a vacuum effect that accelerates the flow in the lend nodule and collectors towards the venous angle in both the thoracic and abdominal regions. The fact that approximately 60% of the lymph nodes in the body are below the diaphragm and the presence of a unique lymphatic drainage area on the peritoneal surface of the diaphragm shows how high the contribution of diaphragmatic movement to lymphatic drainage is.

Effectively fulfilling the function of the diaphragm (respiratory and veno-lymphatic drainage); It has been reported that it depends on the position and range of motion of the diaphragm. The position of the diaphragm is defined by the Zone of Apposition (ZOA) (the distance between the insertion of the diaphragm and its apex).

The shorter/longer than normal length of this area, which normally represents 30% of the total costal surface, is defined as the "suboptimal position". Suboptimal position indicates that the movement of the diaphragm is not optimal. Among the factors that cause suboptimal position of ZOA, somatic disorders and impaired posture are shown in the first place. In addition, it has been reported that the diaphragm is associated with many structures in the abdominal region via the fascia, and the fascial mobility of the abdominal region affects the position and movement of the diaphragm. In addition, it has been reported that the pelvic floor (pelvic diaphragm) opens in parallel with the movement of the thoracolumbal diaphragm, playing a role in controlling the intra-abdominal pressure during inspiration and contributing to the expansion of the limits of the mobility of the diaphragm. All these factors suggest that they may be associated with normalizing the mobility of the abdominal fascia and pelvic diaphragm in order to optimize the position and mobility of the diaphragm, thereby maximizing its function.

Lymphedema treatment is generally performed with Complex Decongestive Physiotherapy (CDP), which is offered as the most valid method by the International Society of Lymphology (ISL) and consists of manual lymph drainage (MLD), skin care, multi-layer bandage application and exercise. In manual lymph drainage, the fluid in the lymphedema area is sent to the nearest healthy absorption areas by using anastomosis routes. Although breathing exercises are performed in the exercise section of the CDP, multidimensional breathing exercises and fascia release applications to optimize the movement of the diaphragm (increasing the movement of the diaphragm, abdominal fascia and pelvic diaphragm) are not used. Investigators think that increasing the working performance of healthy collectors and nodules with applications that optimize the position and mobility of the diaphragm (which may be impaired due to surgical interventions and/or radiotherapy applications) will support impaired thoraco-abdominal lymphatic flow due to interventions for gynecological cancer (radiotherapy and lymph node dissection). The aim of this study is to investigate the effect of multidimensional diaphragmatic breathing exercises and abdominal fascial release techniques on the treatment of lower extremity lymphedema.

There will be two groups in this study. Each group will consist of 15 women aged 25-65 years with Lower Extremity Lymphedema Caused by Gynecological Cancer Treatment. A total of 30 participants will take part in the study. CDP program and placebo fascial release techniques will be applied to the participants in Group 1 and, in addition to the CDP program, the participants in Group 2 will be given multidimensional diaphragmatic breathing exercises and fascial release techniques will be applied.

Participants will be divided into two groups using the block randomization method. Participants will be randomly distributed into 2 blocks of 15 participants. Each group using random number generation technique by computer. All evaluations will be made by the researcher who did not participate in the study.

Diaphragmatic Exercises and Fascial Release Techniques on the Treatment of Lower Extremity Lymphedema

The Effect of Multidimensional Diaphragmatic Breathing Exercises and Fascial Release Techniques on the Treatment of Lower Extremity Lymphedema Caused by Gynecological Cancer Treatment

Demographic, clinical and lymphedema-related data will be recorded with face-to-face interviews.

Both leg circumference measurements will be taken at 4 cm intervals from the medial malleolus. These values will then be converted to volumetric measurement using the ACOLS Limb Volume Calculation program.

The Lower Extremity Functional Scale will be used to determine the functional levels of individuals. The lower extremity functional scale consists of 20 items. Each item is scored between 0-4 and evaluated in 5 options. These options are: extreme difficulty/inability to perform the activity, quite difficult, moderate difficulty, a little difficulty and no difficulty. The total score ranges from 0-80, with higher scores representing better functional level. Individuals will be asked to mark the difficulties they have experienced or will experience in activities related to the cause of lymphedema, and the total score will be calculated.

It will be assessed by the Pittsburgh Sleep Quality Index, which evaluates the sleep quality of the individual for the last month, includes a total of 24 questions. 19 of these are self-report questions and are answered by the patient himself. Five questions are answered by the patient's spouse or roommate and are used for clinical information only and are not included in the scoring. Each question is evaluated with a number from 0 to 3. The sum of the scores of the seven components gives the total score. Sleep quality of those with a total score of 5 or less was "good"; Those with a score above 5 are considered to have "poor" sleep quality.

The disease-specific quality of life of individuals will be evaluated using the Lymphedema Quality of Life Questionnaire. It is designed as two separate forms as lower extremity and upper extremity. A leg questionnaire will be applied to individuals. The questionnaire has 4 sub-dimensions: symptoms, body image, appearance, function, and mode. It contains 26 items in total. Individuals will be asked to tick the box that best describes how they feel about each of the questions, and the total score will be calculated.

Passive Tone will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

Stiffness will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

Decrement will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

Creep will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

Relaxation time will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

Istanbul Medeniyet University

Lecturer

Behaviors and Mental Disorders

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

Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings.

Aescuven Forte oral tablet 150mg (2 capsules/time, 2 times daily) and gradient compression stockings.

150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings.

Daphnetin

150mg (2 capsules/time, 2 times daily) and gradient compression stockings.

Aescuven

Xiaosen Li Li

This clinical trial is designed to learn more about treating patients with lower limb lymphoedema following gynaecological surgery. The main question to be answered is To evaluate the efficacy of Daphnetin capsule in the treatment of patients with lower limb lymphedema following gynaecological malignancy surgery. Participants will take Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) orally at the same time as gradient compression stocking treatment. Researchers will compare 150mg Forte tablets (2 capsules/time, 2 times daily) and gradient compression stockings to see if Daphnetin capsule can be used to treat patients with lower extremity lymphedema following gynaecological malignancy surgery.

This study was a randomised, controlled, open-label, single-centre clinical trial. The objective of this study was to determine the efficacy and safety of Daphnetic capsules compared to Aesculete tablets in the treatment of patients with lower extremity lymphedema following gynaecological cancer surgery. A total of 100 patients with postoperative lower extremity lymphedema (stage I-II) following gynaecological cancer surgery were enrolled in this randomised controlled trial. Patients were randomised 1:1 to the experimental or control group.

Subjects who met the inclusion and exclusion criteria were randomly allocated to the Daphnetin group (study group) or the Aesculeum aesculeum group (control group) in a 1:1 ratio after signing the informed consent form. Both groups were treated for 21 days as a cycle, and efficacy and safety indices were evaluated after the first course of treatment.

Group A: Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings.

Group B: Aescuven Forte oral tablet 150mg (2 capsules/time, 2 times daily) and gradient compression stockings.

female after gynaecological malignancy surgery

Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery

Clinical Trial of Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery

The patient was in the supine position with both lower limbs relaxed. The clinician measured the limb circumference at the dorsum of the foot, the lateral malleolus, the upper edge of the patella and 10 cm above and below with a tape measure and calculated the difference in limb circumference between the two lower limbs.

The GCLQ has good reliability and validity and is easy to administer. It is widely used in the diagnosis and assessment of lower extremity lymphoedema. The questionnaire consisted of 20 questions scored on 7 dimensions: heaviness, oedema (global), swelling (local), numbness, infection, pain and limb function. The answer 'yes' to each question was worth 1 point and the answer 'no' was worth 0 point. A total score of ≥4 points was considered to be lower limb lymphedema (see Appendix II).

2ml of peripheral venous blood was collected from patients and stored in EDTA anticoagulant test tubes. FIB was detected by automatic haemagglutination analyser (STAGO MAXR) in the laboratory department of our hospital.

The First Hospital of Jilin University

vice president

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Laura Havrilesky, MD

Objectives: (1) To determine the incidence of lower-extremity lymphedema after staging surgery for endometrial cancer; (2) to describe lymphedema-related morbidity after staging surgery for endometrial cancer and (3) to evaluate pre- and post-operative quality of life in women with endometrial cancer who undergo staging surgery.

Data analysis and risk/safety issues: The proposed study will consist of a convenience sample of women who undergo minimally invasive surgery for endometrial cancer over a 1 year period. The investigators anticipate enrollment of 75 to 100 women. Frequency tables and difference with its 95% exact confidence intervals between pre-and post-operative lower extremity lymphedema measurements and quality of life questionnaires will be estimated.

Lymphedema in Endometrial Cancer

A Pilot Study of Postoperative Lower-extremity Lymphedema and Quality of Life Among Women Undergoing Endometrial Cancer Staging Surgery

The study team plans to measure QoL via 2 questionnaires, specifically the EQ-5D and FACT-G. FACT-G and EQ-5D-derived utility scores will be calculated and summarized pre- and post-operatively for all patients using descriptive statistics (means, medians, ranges). The difference with 95% exact confidence intervals between pre- and post-operative FACT-G scores and EQ-5D utility scores obtained at each post-operative visit (t1, t2, \& t3) will be estimated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Diaphragmatic Exercises and Fascial Release Techniques on the Treatment of Lower Extremity Lymphedema	NCT05483569	Lower Extremity...	Complex Deconge... Multidimensiona... Facial Release ...	25 Years - 65 Years	Istanbul Medeniyet University
Feasibility and Effectiveness of Lymphedema Education Program After Gynecological Cancer Surgery	NCT06251856	Lower Extremity...	lymphedema educ...	18 Years -	Koç University
Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery	NCT06329167	Lower Extremity...	Daphnetin Aescuven	18 Years - 75 Years	The First Hospital of Jilin University
Lymphedema in Endometrial Cancer	NCT01914276	Lower Extremity... Endometrial Can...		18 Years -	Duke University
Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery	NCT06329167	Lower Extremity...	Daphnetin Aescuven	18 Years - 75 Years	The First Hospital of Jilin University

Spots Global Cancer Trial Database for lower extremity lymphedema