Hysterectomy. Shared Decision Making and Dialogue Tool for the Patient and Doctor

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1 Shared Decision Making and Dialogue Tool for the Patient and Doctor The information contained in this material is for educational purposes only and is not a substitute for medical advice. Results following a hysterectomy may vary. surgery may be appropriate for some patients, and not for others depending on their diagnosis, health, and medical status. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed treatment decision. This brochure was developed by Ethicon, a device manufacturer that markets general surgical instruments used in hysterectomy procedures.

2 Overview What is a hysterectomy There are three main types of hysterectomies A hysterectomy is a surgical procedure that removes part, or all, of your reproductive system, including the uterus and in some cases, the cervix and ovaries. Hysterectomies are used to treat many medical conditions. Partial or supracervical hysterectomy Removal of the uterus only The prospect of having a hysterectomy can be daunting, but you are not alone. In the US, more than 1 in 3 women have had a hysterectomy by age And hysterectomies are one of the most common surgeries among women in the US, second only to C-sections.1-3 Hysterectomies may be performed through minimally invasive laparoscopic surgery (with smaller incisions, if any) or open surgery (traditional surgery with larger incisions). Which type of hysterectomy you need and how it will be performed depends on a number of factors including the reason for your hysterectomy, your body type, your medical history, and your doctor s experience. In the US, more than 1haveinhad3a hysterectomy by age Total hysterectomy Removal of the uterus and cervix Radical hysterectomy Removal of uterus, cervix and upper part of the vagina

3 Hysterectomies are performed to treat many medical conditions Most hysterectomies done in the US are for women diagnosed with uterine fibroids. Uterine fibroids are abnormal but benign (non-cancerous) tumors that grow on the walls of the uterus. 4,5 They can cause excessive pain, bleeding and menstrual cramps. Other leading reasons include 6 : Abnormal uterine bleeding Endometriosis when the tissue lining the uterus grows outside of the uterus, in or on the ovaries, in the fallopian tubes, or involves the bowel or bladder. This can cause pain, cysts, scarring and infertility Uterine prolapse when the muscles and connective tissue holding the uterus in place weaken and the uterus descends into the vagina Atypical endometrial hyperplasia precancer of the cells lining the uterus Ovaries Fallopian Tubes Gynecological cancer uncontrolled growth of abnormal cells in the cervix, uterus, fallopian tubes or ovaries Today, more women and their doctors are questioning whether a hysterectomy is necessary for some of these conditions, especially since less invasive options are now available. For instance, most fibroids, abnormal bleeding and endometriosis can now be managed using minimally invasive methods, such as hysteroscopic, robotic or laparoscopic myomectomy, uterine fibroid embolization, endometrial ablation, pelvic floor repair or medical management. 6,7 These procedures are appropriate for many women, so be sure to discuss these options with your doctor. Uterus Cervix Vagina There are also some women s health conditions that can be treated with nonsurgical methods. These include 6 : Pelvic pain unless there is an underlying uterine problem, a hysterectomy may not be the best way to treat pelvic pain. One study evaluating the causes of pelvic pain in women showed only 5% actually needed a hysterectomy Sterilization There are faster, more cost effective methods for birth control that carry less risk, such as blocking the fallopian tubes. Another alternative, which may be less expensive to the individual, is male sterilization, or vasectomy Cancer prevention some women choose to have a hysterectomy to prevent gynecologic cancer; however, this is an extreme approach to cancer prevention, especially when cancer can be detected early through regular checkups and Pap tests The decision to have a hysterectomy is an important one. It s a decision that shouldn t be made quickly or without weighing the health risks and benefits. In order to reach a decision that both you and your doctor feel good about, you should have an open conversation about the surgery you are considering, and make sure your doctor has answered any questions you may have. Your doctor should help you understand the medical evidence about your surgery and you should help the doctor understand your preferences and values. Together, you can make a well-informed decision.

4 Hysterectomies for the Treatment of Gyneco logic Cancer Some hysterectomies are performed as part of the treatment for gynecologic cancer. There are three major types of gynecologic cancer: Uterine, Ovarian, and Cervical cancer. Uterine cancer is the most common of the three and ovarian cancer is the least common.8-11 If you have been diagnosed with gynecological cancer, the next step is to determine how advanced the cancer is or what stage it is. Once you know the stage of cancer, a treatment plan can be put in place. While these cancers affect different parts of your reproductive system and treatment plans vary depending on the type and stage of cancer, a hysterectomy plays a major role in the treatment for all three. This chart explains the different types of gynecologic cancers and the stages of disease. If you have been diagnosed with gynecologic cancer, chances are you re overwhelmed. However, you will be supported by a large group of healthcare physicians to help you along your treatment journey. Your healthcare team will not only include your primary doctor, but a gynecological oncologist and other specialists such as radiation oncologists, nurses, pathologists, and other support staff. They will be there for you not only for medical care, but also to help manage the physical and emotional symptoms of cancer. Talk to your doctor to understand what each specialist does and how they can help you along your treatment journey. Stage I Stage II Stage III Stage IV Uterine cancer, or endometrial cancer, Cancer only appears in the endometrium (inner lining of the uterus). Cancer has grown outside of the cervix and uterus, but not in the pelvic wall or lower vagina. Cancer has spread to the pelvic wall and/or the lower vagina. Cancer has spread beyond the pelvis to the bladder or rectum. Ovarian cancer affects your ovaries the glands that Cancer only appears in the ovaries. Cancer has spread to the pelvis (that is, the uterus, fallopian tubes, or the bladder). Cancer has spread to other parts of the abdomen. Cancer has spread beyond the peritoneum (a membrane that lines the inner abdomen and some of the pelvis) to distant organs, such as the liver and lymph nodes. Cervical cancer affects your cervix where your uterus Cancer only appears in the cervix. Cancer has gone beyond the uterus. Cancer has spread beyond the uterus to the bladder or rectum and/or to distant organs. affects your uterus (or womb). Most uterine cancer starts in the inner lining of the uterus, called the endometrium. For this reason, uterine cancer is also known as endometrial cancer. produce eggs and female hormones. The most common type of ovarian cancer starts in the epithelial cells that cover your ovaries, so these tumors are known as epithelial ovarian carcinomas. and vagina connect. The cervix is made up of two parts the endocervix and the exocervix. Cervical cancer most commonly starts where these two parts of the cervix meet. Cancer has spread to the cervix.

5 Understand the Different Types of Hysterect omies Partial or Supracervical What is removed The uterus only, leaving the cervix attached to the top of the vagina. Below is a description of each type of hysterectomy. You and your doctor should discuss which procedure is best for your condition. Radical How is it performed What is removed The uterus, cervix and upper part of the vagina with supporting tissues and lymph nodes.* How is it performed Laparoscopic Abdominal Robot-assisted Laparoscopic Surgery Laparoscopic Abdominal Robot-assisted Laparoscopic Surgery Mini Laparotomy * Lymph nodes are part of the lymphatic system, which parallel the blood vessels in the body and wash away abnormal cells and cellular waste products. Removing the lymph nodes around the uterus and cervix helps ensure that any stray cancer cells are also removed. Total What is removed The uterus and cervix. How is it performed In addition to a hysterectomy, your doctor may also recommend one of the following procedures if you have ovarian cancer, an abscess on your fallopian tube or ovary, endometriosis, noncancerous ovarian tumors or cysts, or a twisted ovary.12 Vaginal Oophorectomy Salpingo-oopherectomy Abdominal Removal of one or both of the ovaries. Removal of one or both ovaries and the fallopian tubes. Mini Laparotomy Laparoscopic Robot-assisted Laparoscopic Surgery Laparoscopically Assisted Vaginal

6 Understand How Your Surgery Will Be Perfo rmed Once you and your doctor discuss which type of hysterectomy is appropriate for your condition, you will discuss how the surgery will be performed. There are different approaches a surgeon may use to perform a hysterectomy, for example, a surgeon may access the uterus through the vagina or the abdomen. This chart provides an overview of the different ways your surgery may be performed. In most cases, hysterectomies can be done minimally invasively with a vaginal, laparoscopic, or robot-assisted laparoscopic procedure.13 In some cases, a more invasive type of surgery called an abdominal hysterectomy may be the best option.13 It is important to note that sometimes a procedure can start out as minimally invasive, but may have to be converted to open surgery based on factors such as: obesity, a history of prior abdominal surgery causing dense scar tissue, inability to see organs, bleeding problems during the operation and other underlying medical conditions. This decision is made by the surgeon and is based on what is best for you. Minimally Invasive Surgeries Open Surgery Vaginal Laparoscopic Robot-Assisted Laparoscopic Surgery Abdominal This approach is used for a total hysterectomy procedure This approach is used for partial hysterectomy, total hysterectomy, or radical hysterectomy This approach is used for partial hysterectomy, total hysterectomy, or radical hysterectomy This approach is used for partial hysterectomy, total hysterectomy, or radical hysterectomy How the surgery is performed How the surgery is performed How the surgery is performed How the surgery is performed No visible cuts are made on the surface of your body. Instead, a cut is made inside of the vagina in order to access the uterus. Then, the uterus is pulled down into the vagina so that it can be separated from the ligaments, cervix, and blood vessels that connect it to the body. The uterus is then removed through the vagina and dissolving stitches are used to help the vagina heal. One to three tiny cuts are made on your abdomen to insert laparoscope instruments (small tools with cameras that help see inside your abdomen). This is a type of laparoscopic surgery that uses remote-control instruments. The instruments allow the surgeon finer control with the help of 3-D magnified vision. A large opening (4-6 inches) is made in the abdomen to access the uterus, cervix, and other reproductive organs. The opening is made either horizontally or vertically (from just below the belly button down to the pubic bone). Average length of surgery Average length of surgery 1 hour 1 The uterus is separated from the body and then removed through a small cut at the top of the vagina or through the belly button. 1.5 hours Average length of surgery 2 hours Average length of surgery 2 hours 1

7 What are the possible complications and risks of surgery All surgical procedures have risks, but the risk for serious complications depends on the type of surgery, uterine size, pelvic adhesions, your medical condition and age. Recovery based on type of surgery Stay in hospital (average) Surgery Return to daily activities (average) 1 Vaginal 4 to 5 days Laparoscopic 4 days Robot-assisted Laparoscopic Surgery 3 to 4 days Abdominal 6 days Scarring 15 No visual scar 1 to 3 small scars on the abdomen 3 to 4 weeks 4 to 5 weeks Possible complications include: Adverse reactions to medications Infection at the site of the operation Breathing problems (infection of the lungs) Infection of the bladder Blood clots Problems with anesthesia 1 1 to 3 small scars on the abdomen 16 4 to 6 inch scar on abdomen 4 weeks 6 weeks Bleeding that may require a blood transfusion Injury to bowel, ureters, bladder and blood vessels Internal scarring with creation of adhesions Failure to remove all the diseased tissue What are the long-term effects of a hysterectomy After a hysterectomy, you will no longer get your period and you will not be able to get pregnant. However, you may feel relief from the symptoms that led you to have a hysterectomy. Death What is the recovery like following surgery Your recovery depends on the type of hysterectomy procedure you have, as well as other personal and clinical factors (such as age and other health conditions). Recovery time for a vaginal hysterectomy or laparoscopic hysterectomy is shorter than for an abdominal hysterectomy. On average, depending on the procedure, your hospital stay can last anywhere from 3 to 6 days, and a full recovery may take 3 to 6 weeks.1,-16 You should talk to your doctor about what a full recovery means to you and whether that includes work, exercise or other activities. Keep in mind that even if you feel fully recovered, you should not lift heavy objects or have sex for 6 weeks following surgery.17 Again, based on your procedure and your body, your doctor will know best as to when you can resume your daily activities. You may also experience: Menopausal symptoms (such as hot flashes) Changes in sexual arousal or desire Constipation or difficulty urinating Emotional effects (such as sadness or depression) Some scarring on abdomen Weakened bones, if early menopause occurs Will insurance cover my surgery Your insurance company may cover all or part of the cost of your surgery. Since insurance plans differ in the amount of coverage they provide, it s best for you to check your benefit plan or call your insurance company directly to find out what you will be responsible for paying. You may also want to talk to your doctor s office staff about your health insurance options. They may be able to help guide your conversations with your insurance company.

8 Physician and Patient Conversation Guide and Checklist The best way for patients and doctors to make a shared decision about surgery is to have an open discussion about treatment options and concerns. Your doctor should help you understand how the latest research can influence recommendations about your surgery, and you should help the doctor understand what aspects of your surgery and recovery are most important to you. The benefits of shared decision making A growing body of evidence shows that patients who are more actively involved in their healthcare experience have better health outcomes and incur lower costs. 18 During your conversation, use this checklist to ensure the following topics have been covered to your and your doctor s satisfaction: TOPIC TO DISCUSS: The diagnosis what is causing my symptoms, and why or why not a hysterectomy is recommended The most common reason why women have a hysterectomy is fibroids 4,5 By the age of 60, 1/3 of American women will have had a hysterectomy 5 TOPIC TO DISCUSS: How the diagnosis was determined (which tests were used to make my diagnosis) A routine pelvic exam can help identify uterine fibroids, but an ultrasound or lab tests can help your doctor confirm diagnosis 19 A Pap test can help identify cervical cancer early 20 TOPIC TO DISCUSS: The different types of hysterectomies, the risks and benefits of each, what organs will be removed, and the procedure that is most appropriate for my diagnosis There are 3 types of hysterectomies: partial, total, and radical hysterectomy A radical hysterectomy is recommended when cancer is suspected 6,17 TOPIC TO DISCUSS: The surgical team s level of experience, for example, how many hysterectomies (minimally invasive or open) they ve done is one of the most common gynecologic surgeries in the United States. 1-3 Talk to your surgeon about their experience and training in hysterectomies TOPIC TO DISCUSS: How the surgery is performed and why In most cases, hysterectomies can be done minimally invasively with a vaginal, laparoscopic, or robot-assisted laparoscopic procedure. In some cases, a more invasive type of surgery called an abdominal hysterectomy may be the best option. 13, 21 Discuss these options with your doctor to determine what is appropriate for your condition For some women, an abdominal hysterectomy is best due to uterus size or scarring from previous surgery 13,17,21 TOPIC TO DISCUSS: Potential complications All surgical procedures have risks, but the risk for serious complications depends on the type of hysterectomy, uterine size, pelvic adhesions, your medical condition and age, as well as the surgeon s and anesthesiologist s experience and skill Bleeding and infection are the most common complications of a hysterectomy TOPIC TO DISCUSS: Expected amount of time in the hospital after surgery You may be in the hospital from 3-6 days after your surgery 1, The amount of time you spend in the hospital after surgery will depend on the type of hysterectomy you have and how it is performed

9 Physician and Patient Conversation Guide and Checklist, cont d. Questions and Notes TOPIC TO DISCUSS: What to expect after surgery in terms of: Recovery time, resolution of symptoms, follow-up visits and whether you will need annual Pap tests It may take you anywhere from 3 to 6 weeks to recover after surgery, but every patient is different, so talk to your doctor about their expectations for your recovery -17 The amount of time needed to recover will depend on the type of hysterectomy you have and how it is performed You should still follow-up with your doctor for routine gynecological exams, and you will most likely still need to have regular Pap tests (unless you had a total hysterectomy for a noncancerous condition) 22 TOPIC TO DISCUSS: Typical symptoms following a hysterectomy It is common to experience vaginal bleeding for a few weeks following a hysterectomy; however, you can use sanitary pads during this time (refrain from using tampons until your doctor says you can use them) 17 Some women experience difficulty going to the bathroom (constipation and difficulty urinating) 17 Most women experience pain for the first few days following a hysterectomy; however, it can be handled with medication 17 TOPIC TO DISCUSS: The potential impact on my quality of life, such as effects on sexuality and sexual activity, psychological effects, and menopausal symptoms After your hysterectomy, you may experience greater sexual satisfaction or recognize little change in sexuality. 15 Regardless of how you feel, you should refrain from sex until you re fully recovered It is normal for you to feel sad after a hysterectomy, especially if your fertility is important to you. You should speak with your doctor if your feelings begin to interfere with your quality of life If you have not yet gone through menopause and your ovaries are removed during surgery, you will experience early menopause after your hysterectomy 15 By the end of your discussion, you should feel confident that you understand all the factors involved and that, together with your doctor, you ve made the best decision.

10 Resources What leading associations have to say about hysterectomies American Association of Gynecologic Laparoscopists (AAGL) It is the position of the AAGL that most hysterectomies for benign disease should be performed either vaginally or laparoscopically and that continued efforts should be taken to facilitate these approaches. Surgeons without the requisite training and skills required for the safe performance of vaginal hysterectomy or laparoscopic hysterectomy should enlist the aid of colleagues who do, or should refer patients requiring a hysterectomy to such individuals for their surgical care. 13 The American Congress of Obstetricians and Gynecologists (ACOG) ACOG issued a Committee Opinion in 2017 that examined evidence on the route of hysterectomy for benign (noncancerous) disease. The Committee recommended that vaginal hysterectomy be considered the route of choice, with laparoscopic hysterectomy also considered a viable alternative to abdominal surgery. The Committee Opinion lists the strengths and weaknesses of each approach and cites evidence. 21 American Institute for Minimally Invasive Surgery (AIMIS) It is the position of the AIMIS that patients should be aware of the expertise of their surgeon prior to a procedure being performed. We believe that every hysterectomy for benign disease should be planned secondary to the disease state not to a specific technique. Patients should seek surgeons that are accountable and transparent with surgical outcomes data and who provide hysterectomy options. AIMIS will support patient access to physicians that show outcomes and include the patient in the surgical decision process. References 1. Chen B, Ren DP, Li JX, Li CD. Comparison of vaginal and abdominal hysterectomy: a prospective non-randomized trial. Pak J Med Sci. 20;30(4): Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. rates in the United States, Obstet Gynecol Nov;110(5): Whiteman MK, Hillis SD, Jamieson DJ, et al. Inpatient hysterectomy surveillance in the United States, Am J Obstet Gynecol. 2008;198:34.e1-34.e7. 4. Wright KN, Jonsdottir GM, Jorgensen S, Shah N, Einarsson JI. Costs and outcomes of abdominal, vaginal, laparoscopic and robotic hysterectomies. JSLS. 2012;16: Brigham and Women s Hospital. options. Accessed February 16, MIS for Women.. Accessed February 2, Wright JD, Herzog TJ, Tsui J, et al. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol August;122(201): American Cancer Society. Key statistics for endometrial cancer. Accessed February 16, National Cancer Institute. Cancer stat facts: uterine cancer. Accessed February 16, National Cancer Institute. Cancer stat facts: ovarian cancer. Accessed February 16, National Cancer Institute. Cancer stat facts: cervical cancer. Accessed February 16, Mayo Clinic. Oophorectomy (ovary removal surgery). Accessed February 16, American Association of Gynecologic Laparoscopists. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol Jan-Feb;18(1):1-3.. Sarlos D, Kots L, Stevanovic N, von Felton S, Schär G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol Sep;120(3): Mayo Clinic. Vaginal hysterectomy. tests-procedures/vaginal-hysterectomy/about/pac Accessed February 2, Mayo Clinic. Abdominal hysterectomy. Accessed February 2, American College of Obstetricians and Gynecologists. FAQs. Accessed February 2, James J. Health Policy Brief: Patient Engagement. Health Affairs. February, Accessed January 24, Mayo Clinic. Uterine Fibroids. Accessed February 1, American Cancer Society. Cervical Cancer. Accessed February 20, American College of Obstetricians and Gynecologists. Choosing the route of hysterectomy for benign disease. Committee Opinion No American College of Obstetricians and Gynecologists. Obstet Gynecol 2017:129:e Mayo Clinic. Pap smear. Accessed February 1, 2018.

11 2018 Ethicon US, LLC. All rights reserved

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