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Produced by the Obesity Related Lymphoedema Forum Treatment Pathway for Lymphoedema Patients with a Body Mass Index (BMI) equal or greater than 40 kg/m² Author: Jane Rankin - This pathway is based upon the initial bariatric pathway created by the Lymphoedema Network Northern Ireland (2011) www.lnni.org Purpose: To ensure effective and efficient management of bariatric patients (>/= BMI 40) and health and safety of patients, carers and staff Review Date: October 2018 Related Information: NICE: Obesity prevention - Clinical guideline (CG43) Link: https://www.nice.org.uk/guidance/cg43?unlid=981725192201612111115

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Page 1: Treatment Pathway for Lymphoedema Patients with a Body ... · 1.0 Rationale for the development of an alternative treatment pathway 1.1 The United Kingdom ranks fifth among thirty-one

Produced by the Obesity Related Lymphoedema Forum

Treatment Pathway for Lymphoedema Patients with a Body Mass Index (BMI)

equal or greater than 40 kg/m²

Author: Jane Rankin - This pathway is based upon the initial bariatric pathway created by the Lymphoedema Network Northern Ireland (2011) www.lnni.org Purpose: To ensure effective and efficient management of bariatric patients (>/= BMI 40) and health and safety of patients, carers and staff Review Date: October 2018

Related Information: NICE: Obesity prevention - Clinical guideline (CG43)

Link: https://www.nice.org.uk/guidance/cg43?unlid=981725192201612111115

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1.0 Rationale for the development of an alternative treatment pathway 1.1 The United Kingdom ranks fifth among thirty-one developed nations for rates of obesity. In the past ten years the share of the population measured as obese has increased by a quarter in men and one fifth in women, despite the launch of the national Institute for Health and Clinical Excellence (NICE) Obesity Guidelines published in 2006 (Office of Health Economics (OHE) 2010) (appendix 1). 1.2 There has been a significant increase in lymphoedema referrals for patients with a high BMI. These patients have been receiving complex decongestive therapy as recommended by the National Institute for Health and Technology (NICE) Improving Outcome Guidelines for early and advanced Breast Cancer (2009), the International Lymphoedema Framework (ILF) Best Practice for the management of Lymphoedema (2006) and the Clinical Resource Efficiency Support Team (CREST) Guidelines for diagnosis, assessment and management of lymphoedema (2008). However results obtained have been very limited in relation to the intervention time, highlighting the need to re-address the management pathway to increase the efficiency and effectiveness of the service. 1.3 Lymphoedema is a chronic incurable condition and it is vital that treatment is planned as per the long term conditions (LTC) model (Appendix 2: summary of LTC model requirement: Long Term Conditions Alliance Northern Ireland (LTCANI), 2008); the therapist must support the patient to engage in a programme of self management. Timely and effective intervention is required alongside information and support in managing the conditions on an ongoing and daily basis. 1.4 This was the catalyst for the British Lymphology Society (BLS) to review the possible causes of swelling and the evidence base relating to the management of swelling in the obese patient. From these findings alternative lymphoedema treatment pathways have been proposed in order to provide the most effective treatment, within resources, for those patients with a BMI of 40 and above. 1.5 The 2006 NICE obesity recommendations state: Bariatric surgery is recommended as a treatment option for adults with obesity if all of the following criteria are fulfilled:

they have a BMI of 40 kg/m2 or more, or between 35 kg/m2 and 40 kg/m2 and other significant disease (for example, type 2 diabetes or high blood pressure) that could be improved if they lost weight

all appropriate non-surgical measures have been tried but have failed to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months

the person has been receiving or will receive intensive management in a specialist obesity service

the person is generally fit for anaesthesia and surgery

the person commits to the need for long-term follow-up.

Bariatric surgery is also recommended as a first-line option (instead of lifestyle interventions or drug treatment) for adults with a BMI of more than 50 kg/m2 in whom surgical intervention is considered appropriate.

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1.6 This service is not readily available across the United Kingdom however other regional lymphoedema services have initiated a formal protocol for the super-obese (commonly BMI >60) lymphoedema patients. St Georges NHS Trust (London) run a ten day (in-patient) programme with cardiac, respiratory, metabolic/endocrine, infection, genetics and bariatric assessment completed prior to the commencement of an agreed patient centred programme of care for the lymphoedema management. Other trusts are creating weight management and activity schemes alongside GP referrals to external clubs.

2.0 Classification of overweight or obesity 2.1 The degree of overweight or obesity in adults is defined as follows:

Classification BMI (kg/m2)

Healthy weight 18.5–24.9

Overweight 25–29.9

Obesity I 30–34.9

Obesity II 35–39.9

Obesity III 40 or more

(NICE 2006) 2.2 Assessment of the health risks associated with overweight and obesity in adults should be based on BMI and waist circumference as follows:

BMI classification Waist circumference

Low High Very high

Overweight No increased risk

Increased risk

High risk

Obesity I Increased risk High risk Very high risk

For men, waist circumference of less than 94 cm is low, 94–102 cm is high and more than102 cm is very high.

For women, waist circumference of less than 80 cm is low, 80–88 cm is high and more than 88 cm is very high.

(NICE 2006)

2.3 There may be a cultural variance in the risks associated with BMI. The World Health Organisation (WHO 2004) reviewed scientific evidence that suggests that Asian populations have different associations between BMI, percentage of body fat, and health risks than do European populations and concluded that the proportion of Asian people with a high risk of type 2 diabetes and cardiovascular disease is substantial at BMIs lower than the existing WHO cut-off point for overweight (25 kg/m2). 3.0 Causes of swelling associated with obesity 3.1 The oedema component in obesity is based more on increased lymph production due to the increased ultrafiltration and overburdening of the lymphatic system, which does not need to be defective. In this respect compression therapy is very effective in reducing oedema (Damstra, 2008).

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3.2 When lymphoedema develops the lymph system is less able to remove large fat and protein molecules from the interstitium. As this situation progresses, the fat molecules form networks that are too large to transport into or through the lymph or venous vessels, resulting in pitting oedema (Schmitz 2009). 3.3 Yosipovitch et al (2007) state that obesity greatly effects the skin (the major organ of lymph transport) and is responsible for many changes, for example, in skin barrier function, wound healing, collagen structure and function, lymphatics and the micro and macro-circulations, and thus is implicated in a wide spectrum of dermatological conditions including lymphoedema. 3.4 Loffler et al (2002) showed that increased BMI leads to significant increased cutaneous blood flow and hence to the increase in pressure on the lymphatics to help remove fluid and large molecules.

3.5 Higher BMI leads to less mobility as it takes more effort to transport the extra mass. Reduced mobility means less exercise of the calf muscles, and potentially poorer venous circulation and lymph return. In addition the weight of the intra abdominal bulk creates pressure on the inguinal vessels, making venous and lymphatic return from the legs less efficient.

3.6 Morbidly obese patients can experience breathing difficulties and obstructive sleep apnoea which can result in periodic hypoxia and leg oedema. This can require patients to sleep in recliners (i.e. not flat) thereby not facilitating the circulatory systems to drain the lower limbs whilst asleep. A study by Iftikhar et al (2008) suggested that a third of patients with sleep apnoea have leg oedema. 3.7 Obesity and lack of physical activity are associated with chronic venous insufficiency (CVI), as a result of venous hypertension (Jawein, 2003). 3.8 Recent research has demonstrated that chronic low-grade inflammation is a major factor in obesity (Yudkin, 2007). Inflammatory responses are thought to be the cause of skin changes that are often seen in the obese patient with swelling (Fife and Carter 2009).

3.9 In ORL there are less adipogenic features and therefore adipose hypertrophy does not occur in the same way as in true Lymphoedema (Damastra 2008).

3.10 It is also recognised that some patients may present with asymmetrical swelling and with a BMI>40. It is acknowledged that this is a true lymphoedema which is compounded by obesity related swelling and is managed using a third new pathway. 4.0 Evidence of obesity effecting lymphoedema 4.1 Vignes et al (2010) and Hinrichs et al (2004) noted there was a significant risk of failure of lymphoedema treatment (for breast cancer-related lymphoedema) associated with a younger age and higher body weight and BMI. Mak et al (2009) and Bar et al (2010) also state that weight gain and an elevated BMI are among the strongest predictors of breast cancer-related lymphoedema progression to more advanced stages.

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4.2 In a 2009 study Swenson et al proved, on multivariate analysis, the only factor significantly associated with lymphoedema was being overweight (p = 0.022). 4.3 Peytremann-Bridevaux and Santos-Eggimann (2008) state that the odds ratio for high blood pressure, high cholesterol, diabetes, arthritis, joint pain and swollen legs were significantly increased for overweight and obese adults. 4.4 Karppelin et al (2009) state that an elevated BMI will also increases the likelihood that patients will develop cellulitis. 5.0 Assessment and treatment of Swelling in the morbidly obese patient 5.1 Lymphoedema treatment pathways are supported by the ‘Generic choice model for long term conditions’ (Department of Health (DH) 2007) promoting self care and management, clinical support, supporting independence, psychological support and other social factors. 5.2 Treatment strategies need to be built around the causes of swelling as previously outlined. NICE (2006) recommends that the level of intervention to discuss with the patient initially should be based upon the following assessment:

General advice on healthy weight and lifestyle

Diet and physical activity

Diet and physical activity; consider drugs

Diet and physical activity; consider drugs; consider surgery

The level of intervention should be higher for patients with co-morbidities, regardless of their waist circumference. The approach should be adjusted as needed, depending on the patient’s clinical need and potential to benefit from losing weight. However adults should be given information about their classification of clinical obesity and the impact this has on risk factors for developing other long term conditions.

5.3 Fife and Carter (2008) reported that treating the morbidly obese requires additional staff time and resources such as transfer equipment and bariatric plinths suitable for lifting this weight and to address the health and safety issues regarding moving and handling. The NICE 2006 guidelines specify that bariatric equipment must be available for services treating people with obesity issues. 5.4 This 5 year study also demonstrated that whilst the treatment may be effective, the massive localised oedema will recur if the issue of obesity is not addressed. It is recommended to establish clear criteria and patient partnership/participation before initiating a comprehensive treatment programme to improve outcomes (both for the service and the patient) (Fife and Carter 2008).

BMI classification Waist circumference Comorbidities present Low High Very high

Overweight

Obesity I

Obesity II

Obesity III

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5.5 This group of patients must therefore be assessed, and where necessary, reduce their BMI through a controlled weight management programme. Weight loss can reduce the lymphatic vessels resistance to lymph flow (Van Geest et al, 2003); this must be complimented by an increase in activity levels and exercise tolerance. 5.6 As with all chronic conditions, education is the key to understanding the condition and management of it. Skin changes are frequently seen with chronic swelling, and skin care will therefore form part of the self-management programme. 5.7 As the swelling in obesity is seen as not being the result of impaired lymphatic function, compression remains a very appropriate component of the management. 5.8 NICE 2006 recommends supporting and promoting community schemes and facilities that improve physical activity combined with tailored information. Nutritional support is however difficult to access, especially with the concurrent benefit of clinical psychology. 6.0 Exercise and lymphoedema 6.1 Rehabilitative exercise has always been a core component of lymphoedema management; however until recently there has been some concern over prescribing additional resistance exercise as it was felt that this may increase circulation and actually promote lymphoedema development. 6.2 Many recent articles have been published to demonstrate that controlled and slowly progressed exercise does not exacerbate lymphoedema, in fact the effects of the toning and prevention of muscle atrophy have positively affected and protected limb. It is vital that exercise is prescribed to ensure that progression is gradual and does not damage the weakened tissues. Studies include:

Kwan et al (2011) – a systematic review of contemporary literature concluded there is now strong evidence regarding the safety of resistance exercise without an increase in lymphoedema for breast cancer patients.

Ahmed et al (2006) – RCT (N=85) Slowly progressed and supervised resistance training did not cause or exacerbate existing lymphoedema (breast cancer related) and demonstrated improved quality of life scores (physical and psychosocial).

Schmitz (2009) – RCT (N=295) Slowly progressed and supervised resistance training had no significant impact on arm swelling (breast cancer related) and resulted in a reduction in episodes of related symptoms and improvement in strength

Katz et al (2010) – Pilot (N=10) Lower limb lymphoedema patients did not show an increase limb volume with slowly progressed and supervised resistance exercise but did have 2 unexpected cellulitis events. This pilot is being reviewed to address the potential causes of the cellulits, including the possibility of chance.

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7.0 Treatment Pathways 7.1 An assessment will be completed and followed by an agreed treatment plan and pathway (Appendix 1). 7.2 Those patients with a BMI < 40 will follow the agreed lymphoedema treatment pathway (Appendix 3). 7.2 Appendix 4 shows the proposed alternative treatment pathway for those with a BMI equal or >40 (i.e. false lymphoedema) in concordance with use of compression therapy and weight loss (as per the regional activity listings (5.8). When the BMI falls to < 40 this population will be transferred to the original treatment pathway (Appendix 3) which will offer CDT as an appropriate part of the intervention. Ideally patients should be referred to a specialist service for long term obesity management. 7.3 A third pathway has been developed for those patients presenting with a BMI>40 and with unilateral/asymmetrical swelling i.e. obesity and true lymphoedema (Appendix 5). Patients will be offered CDT or modified CDT with agreement that they simultaneously attend activity and weight management programmes (as per local activity resources). Ideally patients should be referred to a specialist service for long term obesity management. 7.4 Services should have access to healthy eating and activity health promotion tools including presentations which should be an integral part of the management for this patient group. 8.0 Summary BLS believe that by implementing these measures the limited lymphoedema resources will be used more efficiently and effectively, and will promote healthier lifestyles for patient population. Individuals with a high BMI are at risk of developing co-morbidities (Appendix 6) which may have a significant impact on their long term health and well being. By addressing the cause of swelling (obesity) in the first instance, rather than effect (resultant swelling), there will be significantly improved outcomes for the patient at a reduced cost to the NHS, both in the management of the obese patient and associated co-morbidities. This review has also highlighted the need to provide the regional lymphoedema services with suitable equipment to transport and treat the BMI equal or greater than 40 patient populations.

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References:

Ahmed, RL, Thomas, W, Yee, D, Schmitz, KH. (2006). Randomized Controlled Trial of Weight Training and Lymphedema in Breast Cancer Survivors. Journal of Clinical Oncology April 2006 Bar Ad V CAL, Solin LJ, Dutta P, Both S and Harris EE (2010). Time course of mild arm lymphoedema after breast conservation treatment for early stage breast cancer. Int J Radiat Oncol Biol Phys. In press Clinical Resource Efficiency Support Team (CREST) (2008) Guidelines for the diagnosis, assessment and Management of Lymphoedema. CREST, Ireland. Available online at: www.dhsspsni.gov.uk/index/hss/gain.htm Damstra R(2008) Lymphatic system function and obesity — are there links? Journal of Lymphoedema, Vol 3, No 1: 81-85 Department of Health (DH) (2007) Long Term Condition Model Available at: www.dh.gov.uk/publications Department of Health, Social Services and Public Safety Northern Ireland (DHSSPSNI) (2012) Living with Long term Conditions – A policy Framework Fife CE and Carter MJ (2008). Lymphoedema in the morbidly obese patient: unique challenges in a unique setting. Ostomy Wound Management Jane; 54(1): 44-56 Fife C and Carter M (2009) Lymphoedema in Bariatric Patients. Journal of Lymphoedema, Vol 4, No 2 29-37 Hinricks CS, Gibbs JF, Driscoll D, Kepner JL, Wilkinson NW, Edge SB, Fassl KA, Muir R and Kraybill WG (2004). The effectiveness of complete decongestive physiotherapy for the treatment of lymphoedema following groin dissection for melanoma. J Surg Oncol Mar 15: 85(4): 187 – 92 Iftikhar I, Ahmed M, Tarr S, Zyzanski SJ, Blankfield RP (2008) Comparison of obstructive sleep apnea patients with and without leg edema. Sleep Med 9(8): 890–3 Jawein A (2003) The influence of environmental factors in chronic venous insufficiency. Angiology 54(Suppl 1): S19–31 Katz, E, Dugan, NL, Cohn, JC, Chu, C, Smith,RG, Schmitz, KH. (2010) Weight Lifting in Patients With Lower-Extremity Lymphedema Secondary to Cancer: A Pilot and Feasibility Study. Archives of Physical Medicine and Rehabilitation Volume 91, Issue 7, July 2010, Pages 1070–1076

Karppelin M, Siljander T, Vuopio-Varkila I et al (2009). Factors predisposing to acute and recurrent bacterial non-necrotizing cellulitis in hospitalised patients: a prospective case-control study. Clin Microbiol Infect Aug 20

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Kwan, M., Cohn ,J., Armer,J., Stewart, B., and Cormier, J. (2011) Exercise in patients with lymphoedema: A systematic review of the contemporary literature. Journal of Cancer Survivorship, 5(4), 320-336 Loffler H, Aramaki JU, Effendy I (2002). The influence of body mass index on skin susceptibility to sodium lauryl sulphate. Skin Res Technol 8: 19–22 Long Term Conditions Alliance Northern Ireland (LTCANI) (2008). Long Term Conditions: working together Available at: www.ltcani.org.uk Mak SS, Yeo W, Lee YM et al (2009). Risk factors for the initiation and aggravation of lymphoedema after axillary lymph node dissection for breast cancer. Hong Kong Med J June 15(3 Supple 4) : 8 -12 National Institute for Health and Clinical Excellence (NICE) (2006) Obesity: guidance on the prevention identification, assessment and management of overweight and obesity in adults and children (guideline 43).Available at: www.nice.org.uk Office of Health Economics (OHE) (2010) Shedding the pounds: obesity management, NICE Guidance and bariatric surgery in England Peytremann-Bridevaux I and Santos-Eggimann B (2008). Heatlh correlates of overweight and obesity in adults aged 50 years and over: results from the Survey of health, Aging and Retirement in Europe (SHARE). Obesity and health in Europeans aged > or = 50 years. Swiss Med Wkly May 3;138 (17-18): 261-6 Schmitz, KH, Ahmed, RL, Troxel, A, Cheville, A, Smith, R, Lewis-Grant, L, Bryan, CJ, Williams-Smith, CT, and Greene, QP. Weight Lifting in Women with Breast-Cancer–Related Lymphedema N Engl J Med 2009; 361:664-673August 13, 2009

Swenson KK, Nissen MJ, Leach JW and Post-White J (2009). Case control study to evaluate predictors of lymphoedema after breast cancer surgery. Oncol Nurs Forum Mar: 36 (2): 185-93 Van Geest AJ, Esten SC, Cambier JP, et al (2003) Lymphatic disturbances in lipoedema. Phlebologie 32: 138–42 Vignes S, Porcher R, Arrault M and Dupuy A (2010). Factors influencing breast cancer-related lymphoedema volume after intensive decongestive physiotherapy WHO expert consultation (2004) Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet 2004; 363: 157-163. Yosipovitch G, De Vore A and Dawn A (2007) Obesity and the skin: skin physiology and skin manifestations of obesity. J Am Acad Dermatol June: 56 (6) 901-16 Yudkin JS (2007) Inflammation, obesity and the metabolic syndrome. Horm Metab Res 39:707-9

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Appendix 1: NICE (2006) assessment and treatment recommendations Assessment:

1.2.3.4 Surprise, anger, denial or disbelief may diminish people’s ability or willingness to change. Stressing that obesity is a clinical term with specific health implications, rather than a question of how you look, may help to mitigate this.

During the consultation it would be helpful to:

assess the person’s view of their weight and the diagnosis, and possible reasons for weight gain

explore eating patterns and physical activity levels

explore any beliefs about eating and physical activity and weight gain that are unhelpful if the person wants to lose weight

be aware that people from certain ethnic and socioeconomic backgrounds may be at greater risk of obesity, and may have different beliefs about what is a healthy weight and different attitudes towards weight management

find out what the patient has already tried and how successful this has been, and what they learned from the experience

assess readiness to adopt changes

assess confidence in making changes.

1.2.3.7 After appropriate measurements have been taken and the issues of weight raised with the person, an assessment should be done, covering:

presenting symptoms and underlying causes of overweight and obesity

eating behaviour

comorbidities (such as type 2 diabetes, hypertension, cardiovascular disease, osteoarthritis, dyslipidaemia and sleep apnoea) and risk factors, using the following tests – lipid profile, blood glucose (both preferably fasting) and blood pressure measurement

lifestyle – diet and physical activity

psychosocial distress and lifestyle, environmental, social and family factors – including family history of overweight and obesity and comorbidities

willingness and motivation to change

potential of weight loss to improve health

psychological problems

medical problems and medication, including thyroid function / LFTs.

1.2.3.8 Referral to specialist care should be considered if:

the underlying causes of overweight and obesity need to be assessed

the person has complex disease states and/or needs that cannot be managed adequately in either primary or secondary care

conventional treatment has failed in primary or secondary care

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drug therapy is being considered for a person with a BMI more than 50 kg/m2

specialist interventions (such as a very-low-calorie diet for extended periods) may be needed, or

surgery is being considered.

Physical Activity:

1.2.4.18 Adults should be encouraged to increase their physical activity even if they do not lose weight as a result, because of the other health benefits physical activity can bring, such as reduced risk of type 2 diabetes and cardiovascular disease. Adults should be encouraged to do at least 30 minutes of at least moderate-intensity physical activity on 5 or more days a week. The activity can be in one session or several lasting 10 minutes or more.

1.2.4.19 To prevent obesity, most people should be advised they may need to do 45–60 minutes of moderate-intensity activity a day, particularly if they do not reduce their energy intake. People who have been obese and have lost weight should be advised they may need to do 60–90 minutes of activity a day to avoid regaining weight.

1.2.4.20 Adults should be encouraged to build up to the recommended levels for weight maintenance, using a managed approach with agreed goals.

Recommended types of physical activity include:

activities that can be incorporated into everyday life, such as brisk walking, gardening or cycling

supervised exercise programmes

other activities, such as swimming, aiming to walk a certain number of steps each day, or stair climbing.

Any activity should take into account the person’s current physical fitness and ability.

People should also be encouraged to reduce the amount of time they spend inactive, such as watching television or using a computer.

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Appendix 2: Principles of Long Term Condition Management Service User Needs

Healthcare Workforce Needs

Control/empowerment and confidence “What works for me”

Communication skills

Holistic supported care (physical and psychological) for service user and carer – partnership working

Information needs addressed in different formats e.g. one-to-one, leaflet, website:

- Prevention/early identification information and skill sets

- supported self-management information and skill sets e.g. self-massage

- Contact point to access local specialist care / re-enter care

Voice of other patients

Healthy lifestyle education and support e.g. weight reduction and promoting activity

Medicine management information e.g. for cellulitis

Personalised care plan

Identification of “at risk” population

Prevention/awareness education for staff working with “at risk” population

Access to patient information

- Prevention -> for “at risk” groups

- Referrer ->for awareness

- Specialist -> to support self-care

Knowledge of referral pathway

Access to local teams skilled in supporting self-empowerment /management in partnership with service users

Good communication skills

Register

Identification of needs of population and carers

Partnerships with Health Improvement via NHS, council, leisure, support groups

Multi-disciplinary services e.g. psychology or genetics

(Modified from “Living with Long term Conditions – A policy Framework”, Department of Health, Social Services and Public Safety Northern Ireland 2012)

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Appendix 3: Treatment Pathway for Lymphoedema Patients (BMI<40)

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Appendix 4: Treatment Pathway for Lymphoedema Patients with (BMI equal or >40)

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Appendix 5: Treatment Pathway for Lymphoedema Patients with asymmetrical swelling (BMI equal or >40)