Informed Consent, Disclosure and Patient Agreement Forms PATIENT: HOSPITAL: University of Mississippi Medical Center DATE:_______________________ I, ___________________, have been unsuccessful in losing weight by dietary means and request my surgeon to perform the Laparoscopic Roux-en-Y Gastric Bypass on me for the treatment of my morbid obesity. Dr. __________________has explained the Laparoscopic Roux-en-Y Gastric Bypass procedure to me along with the alternatives and potential complications. I realize that risks are common to all surgical procedures and I thoroughly realize that due to my severe obesity and/or co-morbid conditions, I am at an increased risk over the average patient for surgical complications. Regardless of the statement above, I voluntarily wish to proceed with my weight loss operation. ________________ __________________ Patient’s Initials Surgeon’s Initials ALL PRESENT _________________________________ (RELATIONSHIP) ________________________ _________________________________ ________________________ continued on next page Informed Consent and Disclosure Form Page 2 PATIENT: _______________________________________ Laparoscopy surgery is a technique used by surgeons to perform the operation without the need for major open surgery requiring a large incision. The laparoscope is a tubular instrument similar to a telescope that can be placed inside the abdomen. It is usually placed near the belly button after a small (1/2”-3/4”) skin incision is made. After the laparoscope is within your belly, the doctors are able to see your organs and other structures. Additional instruments are needed to do your surgery, so there will be 3-6 additional small tubes that will be put through small ¼” – ½” skin incisions. During the Laparoscopic Roux-en-Y Gastric Bypass procedure, stapling creates a small (15 to 30cc) stomach pouch. The remainder of the stomach is not removed, but is completely stapled shut and divided from the stomach pouch. The outlet from this newly formed pouch empties directly into the lower portion of the jejunum, which is done by dividing the small intestine just beyond the duodenum. The other end is connected into the side of the Roux limb of the intestine creating the “Y” shape that gives the technique its name. You have been informed that laparoscopic surgery may increase operating time and the time that you are asleep (prolonged anesthesia). Occasionally, your surgeon may determine that it is unsafe to continue the surgery through laparoscopy and elect to open your abdomen after the laparoscopic surgery has started. The usual reasons for such a conversion may be an inability to clearly see the surgery area, or to correct bleeding or injury of surrounding structures. I agree to an open operation should the surgeon deem it necessary, and I agree to any emergency surgery that might arise during this procedure. ________________ __________________ Patient’s Initials Surgeon’s Initials I understand that it may be necessary to remove the gall bladder, possibly perform hiatal hernia repair, and possibly perform liver biopsy. A hiatal hernia occurs when the normal opening in the diaphragm is too large. If the problem is not repaired, the stomach or other abdominal contents may bulge (herniate) into the chest, causing heartburn (acid reflux) and serious damage to the esophagus. My surgeon has informed me that there may be additional risks if any of the above additional procedures are performed and I authorize my physicians to perform such other procedures which are advisable in their professional judgment. ________________ __________________ Patient’s Initials Surgeon’s Initials Pictures or video may be taken during laparoscopic surgery and used to: (1.) Show you what has been done. (2.) Be a permanent part of your medical record. (3.) Be used for teaching other patients and other surgeons about these procedures. (If used, your face will not be shown and you will not be identified). I give permission for video and photographs to be taken during surgery to be used as described above. ________________ __________________ Patient’s Initials Surgeon’s Initials continued on next page Informed Consent and Disclosure Form Page 3 PATIENT: ______________________________________ Your primary surgeon will determine the need for an assisting surgeon. I voluntarily permit my surgeon, my physician(s), and such associates, technical assistants and other health care providers as may be deemed necessary to treat my condition which has been explained to me by my physician as: MORBID OBESITY. I understand that my physician might discover other or different conditions which might require additional or different procedures than those planned. I do authorize my physician and such associates, technical assistants and other health care providers to perform such other procedures which are advisable in their professional judgment. I understand that no warranty or guarantee has been made to me regarding this procedure since some patients may not benefit. Just as there may be risks and hazards associated with my present condition, if untreated, there is no guarantee that complications related to the performance of the surgical procedure might not occur. I also realize that in addition, I have the following medical conditions: ________________________________________________________________________ ________________________________________________________________________ A. SOME POSSIBLE COMPLICATIONS DURING SURGERY: 1. Injuries to abdominal organs and/or perforations (an opening of a hole into the stomach or intestine), injury to the liver, pancreas or spleen. Such an injury could require increased surgery time to repair and/or perform splenectomy (removal of spleen). 2. Injury to the diaphragm (muscles that help you breathe). 3. Injuries to arteries or veins which may result in excessive bleeding which could require a blood transfusion. 4. Arrhythmia (irregular heart beat) which may result in the heart not beating or pumping properly or heart attack. 5. Death _____________ ______________ Patient’s Initials Surgeon’s Initials B. SOME POSSIBLE COMPLICATIONS AFTER SURGERY: 1. Blood clots in the leg, pelvis or elsewhere, which can cause circulatory problems in the legs or pulmonary embolism (blood clots migrating into the heart and lungs can sometimes be fatal. 2. Gastric outlet stenosis/obstruction which may result in blockage preventing food from the stomach to enter the intestine. (Could require an outpatient dilation procedure 3. Leaks involving the stomach or intestines leading to peritonitis (infection) and probable reoperation 4. Small bowel obstruction that may result in blockage of the intestines. May require reoperation to correct 5. Distention or edema of the stomach pouch 6. An abscess (a collection of pus) within the abdomen. 7. Pneumonia (infection of the lung). 8. Phlebitis (inflammation of veins). continued on next page Informed Consent and Disclosure Form Page 4 PATIENT: ______________________________________ 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. Wound dehiscence (opening up of the surgical wound). Distention or edema of the stomach pouch An abscess (a collection of pus) within the abdomen. Pneumonia (infection of the lung). Phlebitis (inflammation of veins). Wound dehiscence (opening up of the surgical wound). Breakdown of the staple line Collection of blood, fluid or pus in the surgical wound. Bleeding from any part of the surgery – could require operation and possible blood transfusion. Bezoar obstruction (food particles causing blockage of stomach). Psychological changes/depression. Dysrhythmia (irregular heart beats/which may result in the heart not beating or pumping properly or heart attack). Death. ________________ __________________ Patient’s Initials Surgeon’s Initials C. COMPLICATIONS WHICH MAY OCCUR MONTHS AFTER YOUR SURGERY: 1. Gastroplasty stoma obstruction (blockage of the outlet of the stomach, usually due to food) 2. Gastroplasty stoma stenosis (narrowing of the outlet of the stomach which may result in an inability to eat properly and/or vomiting) 3. Gastroplasty stoma enlarging or swelling 4. Gastroplasty pouch enlarging or swelling 5. Ulcer formation in stomach or intestine 6. Small bowel obstruction (blockage) that may require operation to correct 7. Hernia in the incision that may require surgical repair 8. Cholelithiasis (gallstones in the gallbladder which may result in surgical removal of the gallbladder ) 9. Diarrhea and or foul flatulence 10. Dumping syndrome that may result in dizziness, nausea and diarrhea 11. Permanent alteration of dietary and bowel habits. 12. Difficulty in examining the lower part of the stomach after gastric bypass surgery 13. Vomiting 14. Anorexia (lack or loss of appetite) 15. Hypoglycemia (low sugar levels in blood) 16. Protein malnutrition, vitamin, and trace mineral deficiencies, partial hair loss (which is usually temporary), brittle nails and skin rashes 17. Peripheral and central neuropathy ( nerve tissue malfunction) 18. Psychological changes, including possible effects from new, smaller body image, affecting interaction with friends and family. 19. Liver failure 20. Death ______________ Patient’s Initials __________________ Surgeon’s Initials continued on next page Informed Consent and Disclosure Form Page 5 PATIENT: _____________________________________________ I have received weight loss surgery educational information and have participated in the presurgery educational process explaining my condition, the surgery, and the diet after surgery and my need to participate in on-going support groups after surgery. After review of the written information provided to me, the discussions with the staff and discussions with my physician including the opportunity to ask any questions, I fully understand that any of the complications listed above (but not limited to) could potentially occur and could result in a need for reoperation (s), disability, or death. Furthermore, by initialing after each complication section, I agree that each complication has been explained to my complete understanding and satisfaction. The physician initials after my initials indicate that the physician was present and available to answer any further questions at the time of the completion of this form. I believe that I have sufficient information to give this informed consent and that a copy of this form has been made available to me. I have read and understand this Informed Consent and sign it at my own free will without any coercion. I have read the preceding 4 pages and have discussed this operation and alternate treatment with Dr._____________________________. They have given me ample opportunity to ask questions on specific points, and the surgeon has answered those questions to my satisfaction. I agree to an open operation should the surgeon deem it necessary, and I agree to any emergency surgery that might arise during this procedure. DATE: _____________________ TIME: _________________________A.M. / P.M. _____________________________ Signature of Patient ___________________________________ Signature of Witness _____________________________ Signature of Parent or Legal Guardian __________________________, MD Signature of Physician Obtaining Consent PHYSICIAN'S SIGNATURE________________________________ Informed Consent, Disclosure and Patient Agreement Forms Bariatric Surgery Contract Roux-en-Y Gastric Bypass I, __________________have voluntarily asked Dr.________________ and the treatment team at University of Mississippi Medical Center to perform a Roux-en-Y Gastric Bypass on me to lose weight. I understand that this surgery requires lifelong commitment and major necessary adjustments in my lifestyle and eating habits. I understand that following the surgery, I may not be able to eat certain foods, which I can eat now, and vomiting may occur from time to time, especially if I am not careful about what and how I eat. I hereby promise, if this operation is done on me, I agree to do my part and follow the following guidelines: 1. I will follow the prescribed diet to include purchasing and consuming protein supplements. ____Initials 2. I will purchase and take the prescribed vitamin and mineral supplements for life. (With special emphasis on Vitamin B-12, Iron and Calcium) ____Initials 3. I am now aware that behavior modification is an important on-going process, which will be made easier as a result of my surgery. I understand that such change involves exercise, changes in the type and amount of food I eat, liquids I drink, number of meals I eat per day, and how thoroughly I chew and how fast I eat. _____Initials 4. I will not smoke or use nicotine products after my operation. _____Initials 5. I realize my liver may be sensitive after this surgery and I should stay away from alcohol and any drugs that may cause liver damage. _____Initials 6. I will make and keep my follow-up appointments as required. _____Initials 7. I will schedule and obtain my blood work as prescribed by my physician. _____Initials 8. I will report problems to my physician or treatment team. 9. I understand that the use of some medications, such as long term use of NSAIDS may lead to pouch ulceration. I will notify my surgeon, bariatric team, and/or primary care physician of any mediations that I am prescribed. _____Initials continued on next page 9. FEMALES: I understand that I should not become pregnant within 24 months after bariatric surgery. Further I realize that becoming pregnant during this period after surgery could cause serious harm to my health. I pledge that I will take the proper precautions to prevent becoming pregnant (at least two forms of birth control). I also pledge to seek the advice of a physician should I have any questions as to the proper precautions in prevention of pregnancy. After the initial post-operative period I will seek the advice of a physician prior to stopping preventive measures and possibly become pregnant. _____Initials 10. I will follow and frequently reread bariatric surgery information and my patient education manual _____Initials 11. I will attend surgical weight loss support groups _____Initials 12. I want to have this surgery because of the following: ___I want to be able to play with my children/grandkids ___I want to live a long life ___ I want to be able to walk up a flight of stairs and other physical activities ___I want to improve my self-esteem ___ My weight causes me to be depressed ___I want to socialize outside of my home and not worry about booth size, armless chairs, etc. ___I’m tired of being discriminated against because of my size ___ I want to be more productive at work According to the National Institute of Health, I am __________ lbs overweight, with a BMI _____. My target/goal is to lose _________ of those lbs. I agree to follow all instructions and keep my surgeon informed of my progress regarding my medical problems as well as any change in my address or phone number at all times. I have read and understand this Agreement and sign it at my own free will without any coercion. Patient Signature __________________________________ Date:_________________________ Witness __________________________________________ Date: _________________________ Gastric Bypass contract