PERSONAL AND CONTACT DETAILS First Name Surname Date of Birth Day, Month, Year Address Post Code Country Phone Mobile Email On this form Consultant shall mean consultant or any other doctor level or paramedic as appropriate. CONSULTANT (This section to be completed by the doctor/paramedic responsible for care) Type of Operation/Investigation/Treatment I confirm that I have explained the above operation, investigation or treatment, and such appropriate options as are available, and the type of anaesthetic proposed (general, regional, sedation), if any, to the Patient in terms, which, in my judgement, are suited to the understanding of the Patient. Consultant PATIENT (This section to be completed by the Patient) Please read this form and attached notes very carefully. If there is anything that you do not understand about the explanation, or if you want more information, you should ask the Consultant named above. Please check that all information on the form is correct. If it is, and you understand the explanation, then sign the form. 1
DECLARATION I am the Patient /Parent/Guardian. I agree with what is proposed and has been explained to me by the Consultant named on this form and with the use of the type of anaesthetic I have been told about. I understand that any procedure in addition to the investigation or treatment described on this form will only be carried out if necessary and in my best interests/the best interests of the patient and can be justified for medical reasons. I have told the Consultant about any additional procedures I would not wish to be carried out straightaway without my first having the opportunity to consider them (as specified here): Patient/Parent/Guardian NOTES I gave /the Patient has been given sufficient information, in a way I/ he can understand, about the proposed treatment: and the possible alternatives. Consent given for one procedure or episode of treatment does not give an automatic right to undertake any other procedure. A consultant may, however, undertake further treatment if the circumstances are such that a patient s consent cannot reasonably be requested and provided the treatment is immediately necessary unless the Patient has previously indicated that the future treatment would be unacceptable. For Patient: You may ask a relative, friend or a nurse to be present. Consultant Patient/Parent/Guardian ADDITIONAL SPECIFIC NOTES ON I understood the above named Consultant s explanation of the treatment / operation I agree to undergo as given to me above. In addition I understand other specifics of bariatric surgery which have been explained to me in a clear way. The specifics might be for example these (please specify here): 2
There is no guarantee of surgical approach (laparoscopy, laparotomy) during the operation as well as there is no guarantee of weight loss maintenance after the bariatric procedure is reversed. Bariatric procedures, including reversals, might be associated with higher risk of immediate or long-term serious complications (as has been explained prior to operation). I understand that non-compliance to medical advices may lead to serious and life-threatening complications. Patient/Parent/Guardian STANDARD CONSENT FORM FOR MEDICAL INVESTIGATION, TREATMENT OR OPERATION Definition LGCP Definition SAGB Revision of the Previous Weight Loss Surgery Lysis of Adhesions Placement of a Drain Unpredictable complications Other Death (extremely I understood that the LGCP is an emerging bariatric weight loss procedure similar to vertical sleeve gastrectomy but without the need of gastric resection (removal) or disruption of normal anatomy. I understood that only early clinical studies (up to 12 months after the procedure) demonstrate LGCP to be feasible, safe and effective in the short term when applied to morbidly obese patients. I understood that SAGB is a bariatric weight loss procedure which consists in placing an adjustable band around the stomach and I understand that it will be performed laparoscopically. Revision of previous weight loss surgeries increases operative time and complication rates. Procedures that commonly occur in patients who need revision surgery include, but are not limited to, removal of part of the stomach, placement of a drain, placement of a G-tube, and endoscopy. In case of previous lap-band procedure reversal, the surgeon will remove the old lap-band and the port. In the setting of a previous operation or significant abdominal infection, scarring always results. The degree of scar tissue is unpredictable. Sometimes, depending on the location of the scar tissue, the scar tissue must be cut (called lysis of adhesions ) in order to perform the operation. There are increased risks when a lysis of adhesions is necessary including injury to the intestines, prolonged operative times, and bleeding. A drain is a thin plastic tube that comes out of the body, into a small container to allow for the removal of fluid and the control of infection. The doctor does not routinely place a drain after a lap-band removal. However, in certain rare circumstances, the doctor may elect to place a temporary plastic drain. Medicine is an unpredictable field. No amount of pre-operative testing can assure an uncomplicated outcome. The doctors attempt to minimize any possible chances of misdiagnosis however, no physician or group of physicians are infallible. I have the responsibility to inform the doctors of any concerns, worries or possible complications at the earliest possible time. I agree that my doctors may make recommendations and I take full responsibility if I do not follow these recommendations. Actual risks of the operation vary from person to person. The Bariatric Centre has never had a death associated with any surgery procedure. The mortality rate nationwide is less than 0.2%. I realize, and my (LGCP) (SAGB) 3
rare) Significant Bleeding (very rare) Nausea (common) Prolonged Ventilation (very rare) Heart Attack (very rare) Prolonged Hospital Stay (uncommon) Medical Consultations (uncommon) Deep Vein Thrombosis (DVT)/Pulmonary Embolism (rare) Other Complications that May Be Common Open Procedure (extremely rare) family members realize, that every bariatric surgery is a major surgery and complications of this procedure can be fatal. Usually during the course of a bariatric surgery operation, less than 1 ounce of blood is lost. Bleeding may occur unexpectedly in the operating room. Bleeding may also occur post-operatively in the days after the operation. A transfusion may be necessary in some extremely rare circumstances. Reoperation to stop bleeding may be necessary. The most common cause of post-operative nausea is pain medication. Many patients have nausea the day of their operation. Rarely, nausea will persist for a week. In rare cases, nausea will persist for longer. A patient requiring a prolonged stay on a ventilator (breathing machine)in the intensive care is rare. This may occur for example in very large patients with severe sleep apnoea or after certain significant complications. In these very rare instances, a temporary tracheotomy may be necessary. Although a heart attack is possible, it is very rare. Many patients undergo testing to assess the health of their heart before their procedure. Some patients are asked to obtain cardiology clearance before proceeding with the operation. However, no amount of testing can eliminate the risks of a heart attack. Risk factors for heart disease include increased age, diabetes, hypertension, hypercholesterolemia and a family history of heart disease. Unforeseen complications may result in a prolonged hospital stay. Intensive care admission may be required. My doctors reserve the right consult medical physicians to assist in my care when necessary. Blood clots that form in the legs, and elsewhere, and break off into the lungs are a leading cause of death in this country after any surgical procedure. The doctors will do everything they believe possible to decrease the risk for the formation of blood clots. This includes the use of intravenous heparin (a medication that thins the blood), special foot and leg stockings, walking soon after surgery and sometimes even the use of medication at home after discharge from the hospital. Despite all of these efforts, it is impossible to eliminate the risks of DVT (clots) altogether. There is also a possibility that the medications used to prevent blood clots can cause excessive bleeding. Any symptoms of leg swelling, chest pain or sudden shortness of breath should be immediately reported to the surgeon. My doctors usually use a means of DVT prevention that is not standard practice in the community. My doctors believe, and have the personal experience, that strongly suggests that their means of DVT prevention is ideal for the bariatric patient and is at least as good if not better that standard DVT prevention used in the community. Rare patients develop allergies to heparin sometimes causing very severe reactions. Allergic reactions, headaches, itching, medication side-effects, heartburn/reflux, bruising, anaesthetic complications, injury to the bowel or vessels, gas bloating. Minor wound problems are not infrequent. Minor drainage from the wounds, or even the wounds opening, may occur. Although scars from the laparoscopic procedure are usually small we cannot predict how any patient will form scars. Wound infections should heal over time but may cause a visible scar If, for unforeseen reason, my operation is performed open, I am at higher risk for several complications. This includes wound infection which may cause significant scarring and healing problems, require prolonged wound care and cause 4
Weight Regain Unforeseen Problems Unlisted complications Fees Other discomfort. Incision hernias occur in approximately one-third of patients after an open gastric bypass. Hernias will require an operation to repair. Hernias can cause bowel obstructions and severe consequences if left untreated. There is a higher chance of certain complications including lung infections, pressure ulcers and blood clots after an open operation. There would also be predictably more discomfort and a longer hospital stay. There is no guarantee of weight loss after any bariatric procedure. Even weight regain may occur after bariatric operation. Although this procedure has been performed for many years, there may be longterm problems not known at this time. I understand that unforeseen events may occur that would result in the last minute cancellation or postponement of my operation. My doctor will only cancel my operation in the case of emergency conflicts or if it is my best interest for safety. My doctors are not financially responsible for any costs incurred by rescheduling my operation for any reason. I understand that it is impossible to list every complication possible during and after this procedure. I agree that my doctors have done their reasonable best in listing the most significant complications that may occur. I am responsible for fully understanding all the fees that I may incur. The Clinic has no responsibility or control over the billing and financial obligations related to the treatment in any other medical facility either in the Czech Republic or in the patient s country. The Clinic is not responsible for predicting my hospital charges. I take full responsibility to understand all potential hospital costs. If complications of surgery or significant modifications of surgery occur during or anytime after the planned operation, I understand that additional, significant, professional fees may apply. Bariatric Surgery is a vast discipline. There is no way that my doctors can teach me everything about these procedures. There is no way that my doctors can predict all possible outcomes. This consent is not meant to be all inclusive. Complications or problems may arise that were not specifically addressed. I have reviewed all of the information in this consent form with my immediate family. I have clearly stated to my closest family that I fully understand the risks of surgery and believe that the risks are acceptable. Any conflicting information on the risks and benefits of surgery implied from any other format (internet, brochures, video, and physician interview) is to be superseded by this legal document. I have read, or had read to me, the content of this form, including its appendix (Standard Terms and Conditions) and have no further questions. I wish to proceed with surgery. You must be 18 years old or over to sign. Otherwise your legal guardian must sign the document. Patient/Parent/Guardian Consultant 5
Contract Party 1 These Standard Terms and Conditions stipulate the provision of medical care at OB Klinika, a.s., registered address Pod Krejcárkem 975, 130 00 Prague 3, the Czech Republic (the Clinic ). The Clinic is a fully accredited healthcare provider under laws and regulations of the Czech Republic. All the surgeons and consultants employed at the Clinic are fully qualified and entitled to the provision of healthcare services under laws and regulations of the Czech Republic. Pre-operative Tests and Consultations 2 A rare, but possible, result of the preoperative tests is that they may reveal circumstances (medical or otherwise) which could complicate the operation, posing an increased risk to the person undergoing surgery s (hereafter known as the Patient ) health. In such a case, the Clinic would not undertake the surgery. The Patient is, in such circumstances, required to pay the Clinic a fixed fee of EUR 100, in order to reimburse the cost of the tests. This payment must be made by the Patient before their departure from the Clinic. 3 Informed Consent for Medical Investigation, Treatment or Operation (hereafter known as the Consent ) includes the Standard Terms and Conditions and must be approved by the Patient prior to their surgery. Failure to agree with these, or the withdrawal of the Patient s consent for the surgery, will result in termination of the procedure. The patient will also be required to pay the Clinic a fixed fee of EUR 50, in order to reimburse the cost of the consultation. This payment must be made by the Patient before their departure from the Clinic. 4 Prior to the performance of the operation the Clinic will perform a gastrofiberscopic examination of the Patient s stomach area. Performance of such a test is included in the price for the Procedure. Should this examination identify any medical condition(s), like ulcers or other stomach malfunctions, which contraindicate the Procedure or increase the risk of complications, the Clinic will not proceed with the operation on medical grounds. The Patient will in such case reimburse the Clinic the costs of the pre-operative test as stated in the paragraph 2 above and the costs of the gastrofiberscopic examination of the stomach area of EUR 350. In extremely rare circumstances, a medical condition contraindicating the procedure is identified by the surgeon only after the operation has commenced by visual examination of the inner organs. The Patient agrees and understands that in such a case the operation will be ended and agrees to reimburse the Clinic the costs incurred of EUR 400. 5 The Patient is required to cover the cost of any extra pre-operative tests deemed necessary for their surgery. Such tests will be justified and undertaken by the Clinic on medical grounds; the Patient will be given a clear and comprehensive summary of their requirements and costs beforehand. The Patient s consent is required for such additional tests. 6 The Patient agrees to the recording of their pre-operative consultation(s) with their surgeon(s). This recording is necessary for subsequent clarity in all matters pertaining to the Patient and their procedure. Any refusal to permit such recording may result in the Clinic s termination of the procedure and, subsequently, the patient will be unable to claim any resulting costs incurred. Post-Operative Care 7 Following their operation and before departing the Clinic, the Patient will be given the relevant instructions and recommendations pertaining to their post-operative care (hereafter known as the Instructions ). It is vital that the Patient reads and understands the Instructions and follows them in every detail. Failure to do so may result in aesthetic deterioration following the procedure; furthermore, the Patient may be endangering their health or, at worst, risking their life. Failure to provide the Clinic with completely accurate and up-to-date information about their state of health carries the risk of deteriorating aesthetic effects and a danger to health. The Clinic cannot guarantee the results of any procedure undertaken in either of the above circumstances. 8 Following their operation, the Patient is obliged to provide the Clinic with photographic evidence, detailing the stages of their recovery, of the operated area (and the port area, where applicable). These photographs must be digital, with the accompanying date, and are required at the following post-operative stages: 2 weeks, 4 weeks; 3 months. The Patient may submit this evidence to the agency organising their 6
procedure (hereafter known as the Arranging Agency ). In addition, further photographic evidence may be necessary; each case is considered individually by the Clinic s specialist. Failure to provide any of the aforementioned photographic evidence may negatively affect the impact of any subsequent corrective work or operations performed on the Patient. 9 The Clinic has the Patient s authorisation to submit all information and documents pertaining to them and their procedure (including medical notes, photographic evidence and copies of relevant paperwork) to the Arranging Agency. These are required for the Patient s post-operative care and support undertaken in their country of residence. Furthermore, the so-called before and after photographs of their procedure may be required for medical use by the Clinic; the Patient authorises this usage. 10 Before seeking any kind of medical assistance, the Patient must first contact the Clinic. Subsequently, the Clinic will provide their acceptance, in writing, of any required treatment and the Patient is then free to make their own choice of healthcare provider. This does not apply in life-threatening situations. Customer Complaints 11 The Patient s visual satisfaction with the results of their procedure will naturally vary; within 3 to 4 months of the operation is the standard length of time, although full recovery and satisfaction may take up to 12 months. Taking this into account, should the Patient feel that the results of their procedure are unsatisfactory as a direct result of error or omission on the part of the Clinic, they must immediately contact the Clinic to express their dissatisfaction (hereafter known as the Complaint ). Their Complaint must be made in writing, attaching high quality photographic evidence (complete with date) of the relevant area. 12 The Clinic will, immediately upon receipt of the Complaint, undertake an evaluation of the Complaint. The decision on appropriateness of the Complaint will be made by the Clinic specialist and subsequently reviewed and authorised by the head surgeon of the Clinic. The Clinic will judge medical reasons of possible corrective procedure and communicate the conclusion in writing, with full reasoning, to the Patient within 10 working days of the date of the receipt of the Complaint. 13 Any corrective procedure agreed to by the Clinic as a result of the formal evaluation of a Complaint, as described in Paragraph 11 above, will usually, for medical reasons, be carried out within 6 to 12 months of the original operation date. Corrective Procedure Costs 14 Any corrective work carried out by the Clinic as the direct result of the evaluation procedure of a Complaint, as described above, will be carried out free of charge. The standard time required for the Patient s recovery at the Clinic, is also free of charge. 15 Any other costs than those specifically mentioned in the paragraph 14 above, which may crystallise in connection with the corrective procedure, are not under any circumstances to be covered by the Clinic or any other third party and are solely borne by the Patient. Such costs include, inter alia, travel costs including flight tickets, accommodation after the stay at the Clinic, any costs related to any other person(s) accompanying the Patient, insurance and so forth. Additional Provisions for Swedish Adjustable Gastric Band (SAGB) 16 Any failure or malfunction of the band has to be proven and verified by both the product manufacturer and the site hospital. In such cases, the band will be replaced and the Patient will not be charged. However, this does not include any possible band-related medical complications (including pouch dilatation, slippage or erosion of the band). 17 In cases of port flipping and/or port detachment, corrective surgery will be undertaken at no cost to the Patient. This does not include band removal requested by the Patient due to port detachment, the cost of which will be borne by the Patient. 18 In cases of band slippage and pouch dilatation, it is usually possible to reposition the same band. This, in the majority of cases, requires an elective, rather than emergency, re-operation, the cost of which must be borne by the Patient (approximately EUR 1,500). Costs include the standard pre-operative tests and required stay at the Clinic; they do not include the cost of a new band. 19 In rare cases, so-called band migration may occur. This is when the band moves, over time, through 7
the stomach wall from its position outside the stomach, into the stomach lumen. When the band s entire circumference is inside the stomach, its changed position requires an elective re-operation, rather than emergency surgery. The band is removed; however, it is not possible to fit a new one. The cost of this re-operation is approximately EUR 2000 and must be borne by the Patient. It includes the standard pre-operative tests and required stay at the Clinic. Additional Provisions for Bioenterics Intragastric Balloon (BIB) 20 In very rare cases, the Patient s body cannot tolerate the presence of the balloon. In such cases, the balloon must be extracted before the usual length of time has elapsed; this procedure can be performed at the Clinic or in the Patient s country of residence. The body s rejection of the balloon is considered beyond the Clinic s control and prevention; thus, it cannot be held responsible for refunding the cost of the original operation. 21 The implantation of a BIB into the Patient s body is an integral part of the procedure. However, it is the Patient s responsibility that this implantation is for six months ONLY and that the BIB must NOT be in the Patient s body for any longer than this time. This is for two main reasons: the BIB is not designed to be in the stomach for any longer than six months and the stomach is unable to tolerate the presence of an implanted foreign body past this time. After six months, there is an increased chance of the BIB bursting inside the stomach. Furthermore, the possible risks associated with the BIB increase dramatically after this time: the development of stomach ulcers; inflammation of, and bleeding from, the stomach. All of the above can pose not only an increased risk of medical complications, but also a serious threat to the Patient s health. 22 The arrangement of the timing of the BIB removal is the sole responsibility of the Patient, and they fully agree and understand that they bear full responsibility for any complications arising from their failure to comply with this. All other parties involved in any part of the BIB procedure are not liable for its outcome if, due to the Patient s negligence, the BIB is not extracted at the correct time. 23 The Patient can choose to have the BIB both implanted and extracted at the Clinic. However, the Clinic may refuse to extract the BIB if the Patient fails to arrange for its removal within six months of its implantation date. This failure will render any deposit paid by the Patient for the extraction void and nonreturnable. Additional Provisions for Laparoscopic Greater Curvature Plication 24 The Clinic may cover only immediate, surgical complications directly relating to the surgery. This includes an immediate re-operation and/or prolonged hospitalisation. The Clinic is not obliged to cover the cost of any complications not directly related to the surgery, which must be covered by the Patient. The cost of any re-operation that is required as a result of non-surgical related complications are between approximately EUR 2000 and 4000 and include the standard pre-operative tests and the required stay at the Clinic. Limitation of Liability 25 No injury, damage, loss, delay, additional expenses or inconvenience caused by external forces beyond the Clinic s control or prevention will be taken responsibility for by the Clinic. Furthermore, the Clinic will not be held liable for any medical conditions which were not identified by the necessary pre-operative tests undertaken on the Patient with due care and diligence by the Clinic. For any unexpected events, or those that could not have been reasonably foreseen, the Clinic cannot bear liability. 26 If the Patient fails to meet any of the obligations specified in the Standard Terms and Conditions, the Clinic cannot be held liable or bear the cost of any corrective treatment. This includes the following: failure to follow, in detail, the Instructions (as detailed in paragraph 7 above); failure to provide the necessary photographic evidence following their operation (as detailed in paragraph 8 above); failure to contact the Clinic before finding a different healthcare provider (as detailed in paragraph 10 above). Miscellaneous Provisions 27 Czech law exclusively governs the legal relationship between the Patient and the Clinic; these two parties will make every effort they can to settle any disputes that arise between them as peacefully as possible. If a peaceful solution is not possible, despite their best efforts, then both parties are entitled to submit any resulting legal claims to the relevant court. 8
28 The Clinic and/or Arranging Agency have a right to the protection of their good reputation and the Patient is therefore obliged to refrain from anything that could either jeopardise, or call this into question. Any consultation with the media must be refrained from by the Patient; any Patient breaching this obligation will be held liable for any resulting costs or damages incurred by the Clinic and/or Arranging Agency. 29 Permission is given by the Patient for all video and audio recordings taken by the Clinic. Such recordings are required because they concern the following: information necessary for the performance of the Patient s surgery; documentation of the surgery itself; the subsequent and course of the surgery. These recordings may be used by the Clinic as evidence, mainly in administrative and judicial proceedings, for which the Patient hereby grants agreement. 9