Brad J. Cohen, MD, MBA 2477 Route 516, Suite 103, Old Bridge, New Jersey Office 732-679-6900 Fax 732-679-7900 SURGICAL CONSENT You have elected to have Dr. Brad J. Cohen perform a minimally invasive laparoscopic gynecologic procedure. This consent document describes: 1. The nature and extent of your proposed surgery. 2. The general risks all patients undergo when having surgery. 3. Complications specific to the pelvic surgery which Dr. Cohen is going to perform on you. 4. Alternatives to this surgery. 5. What expectations you may realistically have regarding your outcome. Your laparoscopic surgery may consist of one or more of the following: 1. Subtotal hysterectomy-removal of the top 2/3 of the uterus. 2. Total hysterectomy- removal of the entire uterus and cervix. 3. Removal of one or both ovaries and/or fallopian tubes. 4. Myomectomy-removal of fibroid tumors from the uterus. 5. Robotic Surgery-the use of the da Vinci Robot to aid in the laparoscopic surgery. Nature of Surgery Your procedure will be performed under general anesthesia. The doctor will make an incision near the navel and create a dome from your abdominal wall by infusing carbon dioxide gas at low pressure. He will then insert a telescope which is attached to a camera, to examine the pelvis. The picture can be seen on a flat screen monitor and/or through the da Vinci Robotic Monitor in the operating room. Using two or more small incisions (approximately 1 cm) and electrocautery energy, the doctor will divide the ligaments, cauterize the blood supply, and isolate the uterus. If a supracervical hysterectomy is to be performed, the cervix will be allowed to remain, and the doctor will divide the uterus at the cervical junction. Once isolated, the uterus will be morcellated (shaved into small pieces) and removed through one of the incisions. If your surgery is a total hysterectomy, the surgery is essentially the same, except that
the doctor will dissect the cervix free from the top of the vagina, remove the uterus vaginally, and close the top of the vagina. The fallopian tubes and ovaries can also be removed using laparoscopic techniques. If the procedure is a myomectomy (removal of fibroid tumors), the uterus will remain and the doctor will make incisions over various parts of the uterus that contain fibroids, dissect the fibroids out, and sew the uterine incisions back together. If the surgery involves use of the da Vinci Robot, the procedure is the same except that the robot must be docked and undocked. Robotic surgery has several benefits over traditional laparoscopic surgery. These include: less post-operative pain, less blood loss, lower risk of infection, quicker recovery, better visualization of the pelvis as the robotic monitor is 3D. The gas will be released from the abdominal cavity when the procedure is complete. Sutures will close the various ports, and the skin will be closed with sutures or Dermabond (surgical glue). Patients are usually kept in the hospital 23 hours (overnight) and discharged the following morning. In some instances patients may be discharged home the same day. General Risks The risks of any surgical procedure include: 1. General Anesthesia severe and serious complications from general anesthesia, including coma and death, are extremely rare. Reported at 1 in 250,000. Dr. Cohen has complete confidence in the anesthesia team at St. Peter s University Hospital and Robert Wood Johnson University Hospital. 2. Infection- any surgical procedure carries the risk of infection at the surgical site or skin as a result of contamination during or after the procedure. In general, the incidence of infection in various surgeries is directly proportional to the size of the incision and the amount of time the incision is open. Therefore, given the nature of the procedure being performed, the risk of infection is minimized. To further protect against infection, all patients undergoing advanced procedures are treated with antibiotics just before the surgery is begun. For more information on hospital infections and ways of reducing your chances of such infections, you can visit www.hospitalinfection.org.
3. Bleeding and Blood Transfusion- any surgery involving large blood vessels, such as those which supply the uterus or fibroid tumors, can involve bleeding which may not be immediately controlled, and significant blood loss is possible. Blood loss could be significant enough to result in abandonment of the procedure. If blood transfusion is required, there is the extremely small but real risk of infection by hepatitis or HIV. Dr. Cohen prefers to avoid transfusion unless it is absolutely necessary. You may elect to have a family member bank blood on your behalf. If you are interested in information on this option, please call the office for information. 4. Blood Clots patients, especially smokers and those with a history of blood clots or clotting disorders, always run the risk of developing blood clots in the veins of the lower extremities. These clots can travel to the lungs, causing a severe complication known as a pulmonary embolism. Due to the risk, ALL patients undergoing hysterectomy will have anti-embolism pressure stockings applied to their legs prior to, during, and after surgery. You will also receive Heparin injections regularly during your hospital stay. Complications of Pelvic Surgery Complications specific to the performance of pelvic surgery include injury to the adjacent structures: urinary tract, ureters, bladder, colon or intestines. 1. The possibility of such injury exists whether the surgery is done by traditional open method or laparoscopy. The injury can usually be repaired immediately, since thorough examination of the pelvic contents is made during every step of the surgery and at its conclusion. The possibility exists, however, that a tiny pinhole may have occurred which is not observable at the time of surgery. If such a pinhole occurs in the bladder, intestines, or colon, it could result in leakage, the development of a fistula, possible colostomy, repair of the bladder or ureters, or need for further surgery. 2. Nerve injury is an injury to one or more of the nerves which supply the pelvis and lower extremities. It has been reported in medical literature that injuries to nerves of the legs and nerve
supply to the pelvis have occurred as a result of positioning the patient during surgery, or direct injury to one of the nerves. Alternatives The alternative treatment options have been discussed at length, prior to the decision for surgery. These options have been reviewed and are documented in your electronic medical record. By signing below, it is understood that you have considered such options and have elected to proceed with the proposed surgery. Expectations Most patients go home without the need for post-operative narcotics and use Tylenol, Motrin, or Advil for pain management. Patients are generally seen one week post-operatively, usually drive themselves, and are ready to go back to work after two weeks. Each person is an individual, and some people require a longer recovery time than others. A complete list of post-operative expectations and instructions can be reviewed at www.hystersisters.com. It is most likely that Dr. Cohen has discussed all of this information with you. This is given to you so that you may bring it home and use it as an outline to discuss the surgery further with family members, other physicians, or identify questions for further discussion with the doctor or staff. Kindly sign this form and return it to the office prior to surgery. Your signature indicates that you have read it, understand it, and that all of your questions have been asked and answered. I have read the surgical consent for advanced laparoscopic surgery (with or without the da Vinci Robot). I understand all the information contained herein, and have had the opportunity to have any questions regarding my surgery discussed and answered by the doctor or his staff. Signature of Patient
Signature of Witness Physician