UNC HOSPITALS CHAPEL HILL, NORTH CAROLINA 27514 REQUEST AND AUTHORIZATION FOR UPPER GASTROINTESTINAL ENDOSCOPY AND BIOPSY MIM#180 I request and authorize and/or associates or assistants of his/her choice at the University of North Carolina Hospitals to perform an upper gastrointestinal endoscopy and biopsies on. Patient s Name Authorization is also given for control of bleeding, removal of abnormal growths, and dilation of abnormal areas of narrowing in my digestive tract. If the procedure is performed under the supervision of an attending physician, I understand that residents and/or assistants of his/her choice at the University of North Carolina Hospitals may perform selected tasks, which may include: opening and closing a surgical site; dissecting tissue; removing tissue, blood or body fluids; injecting medication(s); administering anesthesia; implanting devices; inserting/removing/operating an endoscope for diagnosis or treatment; and placing invasive lines. At the time of the procedure, the attending physician will determine the extent of participation by the resident(s) and/or assistant(s) depending on: (1) the complexity of the procedure; (2) the unique circumstances of the patient; and (3) the training and experience of the resident(s) and/or assistant(s). Description of the Procedure: The upper gastrointestinal endoscopy will involve the insertion of a long, flexible, video/fiberoptic instrument called an endoscope through my mouth and into my upper digestive tract. The endoscope will allow health care providers to view and examine my esophagus, stomach, and duodenum, which is the first part of my small intestine. If any abnormalities are seen, one or more biopsies may be performed. A biopsy involves the removal of a small sample of tissue through the endoscope. The tissue will be examined by a pathologist. Occasionally, a small brush is used to obtain cells from the digestive tract to look for evidence of infection or cancer, if these are suspected. Treatment procedures may be performed if upper gastrointestinal endoscopy identifies a source of recent or active bleeding, a growth, or a narrowing in my digestive tract. These procedures may include treating the site of bleeding with an electrocautery, laser, heater probe, injection of agents that cause blood to clot, or placement of small elastic bands onto enlarged veins, and/or removal of food or foreign objects from the digestive tract. An electrocautery is an instrument that directs a high frequency electrical current through an area of tissue. 2/97 1 of 5
Electrocautery may also be used to remove growths or polyps in a procedure called a polypectomy. Narrowed areas of the gastrointestinal tract may be enlarged by the use of balloons or tapered tubes of various sizes. Topical anesthetics will be applied to the back of my throat to minimize any discomfort from inserting the endoscope. I understand that sedatives such as Midazolam, Droperidol, Demerol, or Morphine will be given by intravenous line to cause relaxation and drowsiness. These medications also may cause a brief period of memory loss and result in my not having a recollection of the procedure. Many patients sleep through the procedure, which typically takes 10 to 45 minutes. Risks: The following risks have been associated with an upper gastrointestinal endoscopy. 1. Slowing of breathing and abnormal heart rhythms. Intravenous medications may cause a slowing of breathing, and in rare cases may cause breathing to stop. They also may cause lowering of blood pressure and/or abnormal heart rhythms. I will be carefully monitored for changes in my breathing, blood pressure and heart rhythms. 2. Perforation of the digestive tract. A perforation or tear in the digestive tract occurs in 3 per 10,000 procedures. The risk of perforation occurs mainly during procedures performed to treat a site of bleeding or to enlarge a narrowed portion of the digestive tract through dilation. Perforation may be more likely to occur in the presence of a tumor or other abnormality. Perforations are treated with antibiotics and/or surgery. 3. Effects of injection into enlarged veins and/or banding. An injection of blood clotting agents into enlarged veins and/or banding may cause fever, ulcers, serious infection, as well as scarring and narrowing of the esophagus, which may require treatment. 4. Bleeding. Bleeding from the gastrointestinal tract may occur following endoscopy. Excessive bleeding may require a blood transfusion or surgery. 5. Infection. Patients with heart murmurs or artificial heart valves may be given antibiotics before an endoscopy is performed in order to reduce the risk of infection of the heart valves. 6. Aspiration of stomach contents. Aspiration of stomach contents into the lungs occurs rarely in patients undergoing this procedure. 7. Other complications. Patients may rarely experience an unexpected, adverse drug reaction to the medications. Inflammation, mild abdominal discomfort, bruising or 2/97 2 of 5
infection at the intravenous site, a sore throat, and dental injury are other possible complications of an upper gastrointestinal endoscopy. 8. Death. Death has been reported to follow an upper gastrointestinal endoscopy in 7 per 100,000 procedures, most often in patients who are seriously ill prior to the procedure. Benefits: I understand that an upper gastrointestinal endoscopy may identify a cause for symptoms that may not be obtained by x-ray or other diagnostic means. The procedure is generally very safe and is well tolerated by most patients. Treatments performed through the endoscope often carry less risk than surgery. The purpose of a biopsy is to provide a sample of tissue to examine under the microscope or to study with other tests to make a diagnosis and to provide or guide treatment. Alternative options: I understand that x-rays and surgery are the alternatives to an upper gastrointestinal endoscopy and biopsy. Statement of Voluntary Participation: I have read the information contained in this form, and have had sufficient opportunity to discuss my medical condition and treatment with the undersigned provider. All of my questions have been answered to my satisfaction, and I believe that I have been given adequate information upon which to base an informed consent for the upper gastrointestinal endoscopy, biopsy, and other possible therapeutic procedures. I am consenting to have an upper gastrointestinal endoscopy, biopsy, and other possible therapeutic procedures performed. I understand that I can withdraw my consent at any point. My consent for this procedure is voluntary. I understand that during the course of the upper gastrointestinal endoscopy, biopsy, and other possible therapeutic procedures something may arise which may necessitate procedures in addition to or different from those described above. If such unexpected circumstances arise I further request and authorize the performance of additional operations or procedures which may be considered necessary or advisable by the undersigned provider and his/her associates or assistants. I further request that the administration of such anesthetics as may be considered necessary, desirable, or advisable by the physician responsible for this service. Risks included with the administration of anesthesia or sedation analgesia include: severe blood loss, infection, damage to teeth, mouth, throat or vocal cords, nerve or eye damage, 2/97 3 of 5
drug reaction, slowing or stopping of breathing, failure of the anesthetic or sedation analgesia, cardiac arrest, risks that cannot be predicted, permanent disability or even death. I understand these risks and I consent to the use of any anesthetic or sedation analgesia that my health care providers or the anesthetists believe is necessary. I am aware that the practice of medicine is not an exact science, and I acknowledge that no guarantees have been made concerning the performance, results, or interpretation of the upper gastrointestinal endoscopy, biopsy, and other possible therapeutic procedures. For the purpose of advancing medical education I give my permission for observers to be admitted to the operating room or procedure room, and for UNC Hospitals and the UNC School of Medicine staff to make and use any photographic or other illustrations of me for diagnostic, scientific, educational, or research purposes, provided that my identity is not revealed. I further authorize UNC Hospitals and the UNC School of Medicine staff to examine and dispose of any tissues or parts which may be removed and to use them for teaching, educational, or research purposes, provided that my identity is not revealed. Do Not Resuscitate Orders: I understand that, if I/the patient have a Do Not Resuscitate (DNR) Order currently in effect, it will be suspended temporarily before, during and immediately after the therapy I/the patient will be undergoing unless I place my initials in the following space. Administration of Blood or Blood Products: I have discussed with my health care provider the possibility of administering blood or blood products before, during or after the operation or procedure during my current admission, or for the duration of planned treatment up to one year, as long as my medical condition and proposed treatment and associated risks have not changed. I understand that I/the patient will be given medically necessary blood and blood products unless I place my initials in the following space. I confirm that I have read this form, or it was read to me, and that all blank spaces were filled in and all inapplicable paragraphs, if any, were stricken before I signed below. Signature of Patient/Person Authorized to Sign for Patient Date & Time: Printed Name Relationship to Patient Hospital Number 2/97 4 of 5
PROVIDER CERTIFICATION I hereby certify that the nature, purpose, benefits, usual and most frequent risks of, and alternatives to, the proposed upper gastrointestinal endoscopy, biopsy, and other possible therapeutic procedures have been explained to the patient (or person authorized to sign for the patient) either by a physician or by the provider who is to perform the procedure(s), that the patient has had an opportunity to ask questions, and that those questions have been answered. The patient or the patient s authorized representative has been advised that selected tasks that may be performed by assistants to the primary health care provider(s). I believe that the patient (or person authorized to sign for the patient) understands what has been explained, and has consented to the proposed upper gastrointestinal endoscopy, biopsy, and other possible therapeutic procedures. Physician Signature Physician Name Date: WITNESS CERTIFICATION I hereby certify that the patient (or person authorized to sign for the patient) has EITHER (Check one box): 1. Acknowledged in my presence that he/she has requested an upper gastrointestinal endoscopy, biopsy, and other possible therapeutic procedures and has received an explanation of the nature, purpose, benefits, usual and most frequent risks of, and alternatives to, the operation or procedures, understands that selected tasks may be performed by the health care provider s assistants/residents, has had all of his/her questions answered, has given his/her consent, and has signed the form above; OR 2. Answered "yes" to all of the following questions: a. Did a health care provider explain the operation or procedures to you? b. Did a health care provider explain that selected tasks may be performed by assistant(s)/resident(s)? c. Did a health care provider explain alternative procedures and treatments and their risks and benefits? d. Is this your signature on the consent form? e. Have you given your consent for an upper gastrointestinal endoscopy, biopsy, and other possible therapeutic procedures? f. Have all of your questions about the operation or procedures been answered? Witness Signature Witness Name Date & Time: 2/97 5 of 5