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Robert C Wright, MD, PS – Puyallup, Washington Informed Consent – Sentinel Lymph Node Biopsy for Melanoma (site:__________________) You have been diagnosed as having melanoma, which at minimum demands surgical treatment. Part of the treatment demands knowing if tumor has spread to the lymph nodes. The sentinel lymph node biopsy is a new technique, which allows the doctor to identify the lymph nodes, which would be immediately in the path of spreading cancer (the sentinel lymph nodes). If the sentinel lymph nodes do not contain cancer, further node removal, with its possible complications, may be avoided. It is possible, that following the operation the pathologist may find deposits of cancer in the sentinel lymph node. If the deposit of cancer is present, a return trip to the operating room will be necessary to complete the node dissection. Should this be the case, your surgeon will discuss with you the risks and benefits of further surgery, to allow you to decide the best options for you. Description of the Procedure Several hours before your surgery is scheduled, the area around the tumor is injected with a special radioactive material—this will, drain into the lymphatic system and collect in the lymph nodes. Just before surgery, the surgeon will also inject a special blue dye around the area of the tumor to further assist him in finding the sentinel lymph nodes. During surgery, a “Geiger-counter” type machine is used to identify these sentinel lymph nodes, and these nodes are removed for close inspection. If there is a suggestion of tumor in the lymph node(s), or if we are unable to find any appropriate sentinel lymph node, we will then do a formal node dissection, cleaning out the rest of the lymph nodes where the tumor can spread. Sentinel node biopsy is usually done at the same time as wide excision of the melanoma. Risks/Complications of Treatment Treatment risks fall into two categories; those that could happen during any operation under anesthesia, and those that are specific for a sentinel lymph node biopsy. In any sort of medical treatment, it is impossible to predict all the things that could go wrong. Fortunately, complications are the exception rather than the rule. Every reasonable effort is made to avoid complications. The most common possible complications are as follows: Possible complications of major surgery 1. Bleeding – this is a problem that could happen any time the skin is cut. The need for a blood transfusion is rare. 2. Infection – we take special care to prevent an infection, but it is always a possibility. An infection can delay further treatment and prolong healing. 3. Reactions to medications – this could be many things, from a minor rash, to possible death. 4. Reactions to anesthesia and surgery – this could show up as a heart attack, blood clots, pneumonia, sore throat, or, in rare cases, death. 5. Poor wound healing – breakdown of the incision. Possible complications of sentinel node biopsy 1. Inability to identify the sentinel lymph nodes(s) – a complete node dissection may then be done. 2. Paralysis/atrophy of some muscles. This is uncommon. 3. Numbness below the incision. This is common in some node areas. 4. Swelling (lymphedema) on the side of the operation, below the incision. May affect the whole arm or leg. This is uncommon. (see other side) 5. Seroma formation – This is a collection of fluid beneath the wound. 6. Recurrence of the cancer – this could occur either within the area of the melanoma operation or somewhere else in the body. Cure cannot be guaranteed. Anticipated Recovery/Expected Rehabilitation Recovery is quite variable, depending on the individual. You should be able to use arms and legs within days following the surgery. Most people are able to go home the day of surgery or the next day. The amount of time it takes before you will be able to return to work will partly depend on the type of work you do, and the speed at which you heal. Most people with light job duties can return within two weeks; if you do heavy lifting, you might want to wait up to one month before returning to work. Most people do not require special rehabilitation in order to get function back. Further treatment of the melanoma may be required, including interferon immune therapy or node dissection. The final pathology report after surgery will influence this decision. Consent for Treatment I understand my condition to be a melanoma cancer and am aware of its risks if untreated. I have read and understand the above explanation of the procedure being proposed. My surgeon has answered my questions, and I choose to proceed with surgery. I understand that every operation may yield unexpected finding. I give the surgeon permission to act on his best judgment in deciding to remove or biopsy tissues that appear to be diseased, understanding that complications may arise from that action. I understand that while most people with melanoma benefit from this operation, I may not. My condition may not improve, and it may worsen. No absolute guarantee can be made. HIPAA: Before and after surgery, unless otherwise requested in writing by you, visitors whom you invite to attend the surgery will be informed of the surgical finding, your surgical status, and anticipated recovery issues for effectiveness of communications. Because of the anesthetic, you may or may not remember these important details. PRINT NAME OF PATIENT __________________________________________________________________ SIGNATURE __________________________________________________________ DATE _________________ WITNESS ____________________________________________________________ DATE _________________ SURGEON ____________________________________________________________ DATE _________________ RELATIONSHIP TO PATIENT IF SIGNATURE OF LEGAL GUARDIAN ___________________________________ I waive the right to read this form, and do not want to be educated and informed of treatment risks; nonetheless, I understand the need for this surgery and grant permission to the surgeon to proceed on my behalf. SIGNATURE _____________________________________________________ DATE _________________ 06/03ljb