Axillary Surgery. Sentinel Node Biopsy. Intraoperative Assessment (OSNA) Patient Information to be retained by patient

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1 PLEASE PRINT WHOLE FORM DOUBLE SIDED ON YELLOW PAPER Patient Information to be retained by patient affix patient label Sentinel Node Biopsy What is sentinel node biopsy? The lymphatic drainage from your breast moves up the lymph nodes in your axilla (armpit) in a stepwise fashion. The sentinel lymph nodes are the first nodes which would contain cancer cells if they have spread from cancer in the breast. A sentinel node biopsy involves identifying and removing these first nodes and establishing if they contain tumour cells. A sentinel node biopsy typically involves removing between 1 and 3 lymph nodes. Why do I need this procedure? Knowing whether the lymph nodes contain cancer cells is important in order to stage the breast cancer. If the sentinel node is positive you will be offered an axillary clearance (removal of all the nodes from under your arm). This will reduce the chances of the cancer coming back in the lymph nodes under your arm and will help guide any further treatment. What alternative treatments are there? Prior to the development of sentinel node biopsy, breast surgeons often carried out an axillary sample. This involved removing 4 lymph nodes from the lower axilla (armpit). Evidence has shown that sentinel node biopsy is a more accurate way of staging the axilla and may result in fewer side effects than a sample. In a very small group of patients (less than 5 in 100) the techniques for identifying the sentinel node fail. Under these circumstances we would carry out an axillary node sample. Intraoperative Assessment (OSNA) What does this mean? One Stop Nucleic Acid Amplification (OSNA) is a relatively new technique which allows us to very accurately determine whether your sentinel lymph node(s) contain cancer cells during your initial surgery. It is a validated test using biological molecular techniques to analyse the whole lymph node. The results of the test will be reported to your surgeon as: NEGATIVE no further surgery to the axilla (armpit) is required MACROMETASTASES the rest of the lymph nodes from under your arm will be removed this is an axillary clearance MICROMETASTASES your surgeon will discuss with you the plan if your result is this before your operation. The decision will be based on the tumour characteristics and a large body of robust evidence from clinical trials. If you need further clarification, please discuss this with your surgeon. In a very small number of cases (less than 4 in 100) the test does not provide us with a valid result. Under these circumstances your surgeon will make a judgement based on patient and tumour characteristics as to whether to remove the rest of the lymph nodes. Why do I need this procedure? This procedure allows us to accurately and quickly determine whether the sentinel node contains cancer cells. It allows us to proceed to an axillary clearance if necessary and prevents the need for a second operation for axillary surgery. RCHT Design & Publications 2016 Patient information - Page 1 of 4 CHA3229 V2 Reviewed 07/2016 Review due 07/2019

2 Patient Information to be retained by patient What alternative treatments are there? We are one of a few centres in the United Kingdom who offer this technology. Conventionally, sentinel node biopsy does not require a drain (plastic tube) to the axilla whereas axillary clearance requires a drain being left in situ for up to one week. Some patients find the idea of waking up with a drain and therefore knowing their sentinel node is positive too difficult to cope with. They would rather find out the result of their sentinel node biopsy in out-patients and proceed to further axillary surgery after discussion. If you feel this may apply to you please discuss this with your breast care nurse and surgeon and your sentinel node will be analysed in the routine way by the histopathologists. Axillary Node Clearance What does this mean? The lymph glands under your arm drain a large area of the lymphatic fluid from your breast and arm, and sometimes a tumour can spread to the lymph glands. Axillary node clearance involves removing most of these glands. This will reduce the possibility of a recurrence of the tumour under the arm as well as informing us how many of the glands are affected by the tumour, which helps us plan the next stage of your treatment. What alternative treatments are there? Radiotherapy to the axilla is a possible alternative to axillary clearance. However, this does not provide any information about the number of lymph nodes containing cancer and the breast team s present recommendation in your case is that surgery is the best form of treatment at this stage. How do I prepare for it? Most patients attend a pre-admission clinic where we will ask for details of your medical history and carry out any necessary clinical examinations and investigations. Please ask us any questions about the procedure, and feel free to discuss any concerns you might have. You will also have the opportunity to discuss any concerns or queries with a member of the breast care nursing team. Do not eat anything for at least 6 hours before your operation. This is to make sure your stomach is empty when you have your anaesthetic. Drinks containing fats (e.g. tea or coffee with milk) and sweets all count as food. You can drink water or a drink without fats in it (e.g. black coffee) until 2 hours before your operation. You may also have small sips of water to take tablets. There is a hospital leaflet about having an anaesthetic. Ask the staff for a copy if you would like one. You will be given a general anaesthetic during the operation which will keep you asleep. The anaesthetist will come and see you before your operation to discuss this with you. You will be able to ask them questions about the anaesthetic. A member of the surgical team will also see you on the ward. This is usually the surgeon that will perform your operation. Feel free to ask any questions you have about the operation or what will happen after the surgery. The surgeon will draw an arrow on the side to be operated on and check that this consent form has been completed and signed. Patient information - Page 2 of 4

3 Patient Information to be retained by patient What does it involve? Your surgeon will decide which technique they are going to use to locate the sentinel node. This may involve the injection of a radioactive isotope and / or blue dye around your areola (pigmented area around your nipple), after you are asleep. Your surgeon will make a small incision in your armpit and identify and remove the sentinel lymph node(s). They will then be passed to a biomedical scientist (if you are undergoing OSNA), who will analyse them whilst you are asleep. Your surgeon will then proceed to carry out your breast surgery. If your sentinel nodes are positive your surgeon may go on to perform an axillary clearance. The majority of the lymph nodes from your axilla will be removed. There are important blood vessels and nerves within your axilla which will be identified and preserved. Your surgeon will leave a soft plastic drainage tube within the space in your axilla to drain away the tissue fluid that will be produced as a result of your surgery. What happens afterwards? You will normally spend a night in hospital. The drain will need to stay in until the amount draining over a 24 hour period is less than mls. This generally takes between 3 and 5 days. You can go home the day after your surgery with the drain in (depending on what surgery you have had to your breast) and the district nurses will take over the management and removal of the drain. It may be necessary for you to spend longer in hospital. In that case the nursing team will encourage you to be up and about as much as possible. Before you go home, the nursing staff will check that you are well enough and that the conditions at home are such that you can manage safely. You will be given a leaflet about arm and shoulder exercises depending on the type of axillary surgery you have had. Are there any risks or complications? As with all procedures there are risks from having this operation: General Risks Risk from the anaesthetic: The risk to a healthy patient of problems arising from an anaesthetic is very small. However, each year in the UK a few healthy people will die or suffer serious heart, lung or brain injury following an anaesthetic. For a woman who is otherwise in good health, the risk of a serious complication due to general anaesthesia is less than 1%. Bleeding: This is usually minor and is stopped during the operation. Occasionally, patients develop a collection of blood called a haematoma, which requires a second operation. For axillary surgery it is less than 1%. Patient information - Page 3 of 4

4 Patient Information to be retained by patient Infection: All surgery has a risk of infection. If the wound becomes red, hot or weeps, or you feel unwell you should consult your doctor. Treatment will involve taking antibiotics. DVT/PE: With all surgical procedures there is a risk of developing a clot in the deep veins of the leg, deep vein thrombosis (DVT). In a very small number of patients a bit of this clot breaks off and lodges in the lungs. This is a pulmonary embolus and in very extreme cases can be life-threatening. Your surgical team will prescribe you compression stockings and/or blood thinning medication after careful assessment of your individual risk. Risks specific to axillary surgery Reaction to blue dye: This may occur if your surgeon chooses this method of identifying the sentinel lymph node. The skin may become stained with blue around the site of injection and may take months to fade. In a small number of patients this staining is permanent. A severe reaction to the dye (anaphylaxis) has been reported and occurs in less than 1 in 1000 patients. If this occurs you may need to be monitored in an area of high dependency after your surgery, or your surgery may be abandoned. Pain: A degree of pain is likely after any surgery. We aim to manage your pain with painkillers to an acceptable level. In about 30 in 100 patients undergoing axillary surgery some degree of pain continues beyond the early postoperative period. There is evidence to suggest that if we get on top of your pain in the early post-operative period we can reduce the chance of it becoming a chronic problem. If the pain or numbness and tingling continues to be troublesome please let your surgeon or breast care nurse know and we can give you a medication to manage the pain. Numbness: The nerves which supply sensation to the back and inner part of your upper arm may be damaged during the procedure. You may experience numbness and discomfort in the armpit and upper arm. The numbness usually lessens slowly over time and you will become used to it. Shoulder stiffness: Your shoulder may become stiff after your operation. Performing the exercises from your information leaflet will help to prevent this. Seroma: This is a collection of fluid under the skin after surgery. It is quite common after axillary clearance, but is easily treated by drainage through a small needle. Draining the seroma is a very simple procedure that can be done by a member of the Breast Team. Lymphoedema: This is swelling in the tissue below the skin caused by lymph fluid which cannot drain away. This can occur when the lymph glands are removed (by surgery) or blocked (by radiotherapy). Your hand and arm may swell at any time after surgery. It can affect about 20 to 30% of women but only around 5% to a significant degree. There are certain precautions you need to take to prevent lymphoedema, these will be discussed with you by the Breast Care Team. Winged scapula: This is a rare complication which occurs if one of the nerves in your axilla is stretched or cut during the procedure. If it occurs the shoulder blade becomes prominent and you may notice less function in your arm and shoulder. It occurs in less than 1 in 100 patients and may resolve over time with physiotherapy. Occasionally if the nerve is cut it may be permanent. If you would like this leaflet in large print, Braille, audio version or in another language, please contact the Patient Advice and Liaison Service (PALS) on Patient information - Page 4 of 4

5 CONSENT FORM 1 PROCEDURE SPECIFIC PATIENT AGREEMENT... Axillary surgery +/- Sentinel node biopsy +/- Intraoperative assessment (OSNA) +/- Axillary clearance NHS number: Name of patient: Address: Date of birth: CR number: AFFIX PATIENT LABEL STATEMENT OF HEALTH PROFESSIONAL (to be filled in by health professional with appropriate knowledge of proposed procedure, as specified in consent policy) I have explained the procedure to the patient. In particular, I have explained the intended benefits: To determine whether the lymph nodes under your arm contain cancer and remove all the lymph nodes if they contain cancer Significant, unavoidable or frequently occurring risks: Bleeding, infection, DVT/PE, reaction to blue dye, pain, numbness, shoulder stiffness, seroma, lymphoedema Uncommon but more serious risks: Anaphylaxis to blue dye, winged scapula Rare but serious risks: Anaesthetic risk which includes a very small risk to life or limb from complications such as heart attack and stroke. Any extra procedures which may become necessary during the procedure: Blood transfusion (required very infrequently) Other procedure (please specify): I have also discussed what the procedure is likely to involve, the benefits and risks of any available alternative treatments (including no treatment) and any particular concerns of this patient. I have given and discussed the Trust s approved patient information leaflet for this procedure: (CHA3229) which forms part of this document. I am satisfied that this patient has the capacity to consent to the procedure. This procedure will involve: General and/or regional anaesthesia Local anaesthesia Sedation Health Professional signature: Date: Name (PRINT): Job title: STATEMENT OF INTERPRETER (where appropriate) I have interpreted the information above to the patient to the best of my ability and in a way in which I believe he/she can understand. Interpreter signature: Name (PRINT): Date: Consent Form () - Page 1 of 2 CHA3229 V2 Reviewed 07/2016 Review due 07/2019

6 affix patient label STATEMENT OF PATIENT Please read this form carefully. If your treatment has been planned in advance, you should already have a copy of the patient information leaflet which describes the benefits and risks of the proposed treatment. If not, you will be given a copy now. If you have any further questions, do ask - we are here to help you. You have the right to change your mind at any time, including after you have signed this form. I agree to the procedure or course of treatment described on this form. I understand that you cannot give me a guarantee that a particular person will perform the procedure. The person will, however, have appropriate experience. I understand that I will have the opportunity to discuss the details of anaesthesia with an anaesthetist before the procedure, unless the urgency of my situation prevents this. (This only applies to patients having general or regional anaesthesia). I understand that any procedure in addition to those described on this form will only be carried out if it is necessary to save my life or to prevent serious harm to my health. I understand that tissue samples will only be taken in relation to the procedure explained to me. No samples will be taken for quality control, clinical education or research purposes. I have been told about additional procedures which may become necessary during my treatment. I have listed below any procedures which I do not wish to be carried out without further discussion. I have received a copy of the Consent Form and Patient Information leaflet: (CHA3229) which forms part of this document. Patient signature: Name (PRINT): Date: A witness should sign below if this patient is unable to sign but has indicated his or her consent. Young people / children may also like a parent to sign here (see guidance notes). Witness signature: Name (PRINT): Date: CONFIRMATION OF CONSENT (to be completed by health professional when the patient is admitted for the procedure, if the patient has signed the form in advance). On behalf of the team treating the patient, I have confirmed with the patient that they have no further questions and wish the procedure to go ahead. Health Professional signature: Date: Name (PRINT): Important notes (tick if applicable): See advance decision to refuse treatment Job title: Patient has withdrawn consent (ask patient to sign/date here) Patient signature: Name (PRINT): Date: Consent Form () - Page 2 of 2

7 File copy CONSENT FORM 1 PROCEDURE SPECIFIC PATIENT AGREEMENT... Axillary surgery +/- Sentinel node biopsy +/- Intraoperative assessment (OSNA) +/- Axillary clearance NHS number: Name of patient: Address: Date of birth: CR number: AFFIX PATIENT LABEL STATEMENT OF HEALTH PROFESSIONAL (to be filled in by health professional with appropriate knowledge of proposed procedure, as specified in consent policy) I have explained the procedure to the patient. In particular, I have explained the intended benefits: To determine whether the lymph nodes under your arm contain cancer and remove all the lymph nodes if they contain cancer Significant, unavoidable or frequently occurring risks: Bleeding, infection, DVT/PE, reaction to blue dye, pain, numbness, shoulder stiffness, seroma, lymphoedema Uncommon but more serious risks: Anaphylaxis to blue dye, winged scapula Rare but serious risks: Anaesthetic risk which includes a very small risk to life or limb from complications such as heart attack and stroke. File copy Any extra procedures which may become necessary during the procedure: Blood transfusion (required very infrequently) Other procedure (please specify): I have also discussed what the procedure is likely to involve, the benefits and risks of any available alternative treatments (including no treatment) and any particular concerns of this patient. I have given and discussed the Trust s approved patient information leaflet for this procedure: (CHA3229) which forms part of this document. I am satisfied that this patient has the capacity to consent to the procedure. This procedure will involve: General and/or regional anaesthesia Local anaesthesia Sedation Health Professional signature: Date: Name (PRINT): Job title: STATEMENT OF INTERPRETER (where appropriate) I have interpreted the information above to the patient to the best of my ability and in a way in which I believe he/she can understand. Interpreter signature: Name (PRINT): Date: Consent Form (File copy) - Page 1 of 2 CHA3229 V2 Reviewed 07/2016 Review due 07/2019

8 File copy affix patient label STATEMENT OF PATIENT Please read this form carefully. If your treatment has been planned in advance, you should already have a copy of the patient information leaflet which describes the benefits and risks of the proposed treatment. If not, you will be given a copy now. If you have any further questions, do ask - we are here to help you. You have the right to change your mind at any time, including after you have signed this form. I agree to the procedure or course of treatment described on this form. I understand that you cannot give me a guarantee that a particular person will perform the procedure. The person will, however, have appropriate experience. I understand that I will have the opportunity to discuss the details of anaesthesia with an anaesthetist before the procedure, unless the urgency of my situation prevents this. (This only applies to patients having general or regional anaesthesia). I understand that any procedure in addition to those described on this form will only be carried out if it is necessary to save my life or to prevent serious harm to my health. I understand that tissue samples will only be taken in relation to the procedure explained to me. No samples will be taken for quality control, clinical education or research purposes. I have been told about additional procedures which may become necessary during my treatment. I have listed below any procedures which I do not wish to be carried out without further discussion. File copy I have received a copy of the Consent Form and Patient Information leaflet: (CHA3229) which forms part of this document. Patient signature: Name (PRINT): Date: A witness should sign below if this patient is unable to sign but has indicated his or her consent. Young people / children may also like a parent to sign here (see guidance notes). Witness signature: Name (PRINT): Date: CONFIRMATION OF CONSENT (to be completed by health professional when the patient is admitted for the procedure, if the patient has signed the form in advance). On behalf of the team treating the patient, I have confirmed with the patient that they have no further questions and wish the procedure to go ahead. Health Professional signature: Date: Name (PRINT): Important notes (tick if applicable): See advance decision to refuse treatment Job title: Patient has withdrawn consent (ask patient to sign/date here) Patient signature: Name (PRINT): Date: Consent Form (File copy) - Page 2 of 2

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