INFORMED CONSENT FOR GASTROINTESTINAL ENDOSCOPY

Explanation of Procedure

Endoscopy is the direct visualization of the digestive tract with a lighted flexible tube. During your examination, the inside lining of the digestive tract will be inspected thoroughly and may be photographed. Certain diagnostic or therapeutic interventions may be performed. Biopsies may be performed if an abnormality is seen or suspected, and this tissue may be sent for microscopic study. Small growths can frequently be completely removed (polypectomy). Brushing of the mucosal lining may be obtained for evaluation for abnormal cells, or cytology. Fluid may be obtained for chemical analysis. Narrowing or strictures may be stretched or dilated. Pictures may be taken of the digestive tract during the procedure.

• Esophagogastroduodenoscopy (EGD) - The examination of the esophagus, stomach, and duodenum to look for ulcers, tumors, inflammation, and areas of bleeding.
• Dilation of the esophageal stricture; treatment may be performed by various means, including manual, wire-guided or balloon dilators of graded sizes.
• Flexible Sigmoidoscopy - Examination of the first portion of the colon requiring preparation with diet, enemas and medication.
• Colonoscopy - Examination of all or a portion of the colon requiring careful preparation with diet, enemas and medication.
• EUS (Endoscopic Ultrasound) - The combination of ultrasonography and endoscopy to image the gastrointestinal wall and adjacent structures.
• FNA (fine needle aspiration) - The method of obtaining tissue for histological diagnosis via a hollow core needle using endoscopic ultrasound guidance.
• PEG Placement (percutaneous endoscopic gastrostomy) - Used in conjunction with gastroscopy, the insertion of a tube into the stomach/small intestine through a small incision in the abdomen for feeding or medication.
• Percutaneous Endoscopic Gastrostomy (PEG) tube removal and exchange - The removal and replacement of a feeding tube through the abdominal wall into the stomach.

Risks and Complications

Gastrointestinal endoscopy is generally a low-risk procedure. However, all of the below complications are possible. Your physician will discuss the frequency with you if you desire, with particular reference to your own indications for gastrointestinal endoscopy. YOU MUST ASK FOR YOUR PHYSICIAN IF YOU HAVE UNANSWERED QUESTIONS ABOUT YOUR TEST.

• Perforation - Passage of the instrument may result in an injury to the gastrointestinal tract wall with possible leakage of gastrointestinal contents into the body cavity. If this occurs, surgery to close the leak and/or drain the region is usually required.
• Bleeding - Bleeding, if it occurs, is usually a complication of biopsy, polypectomy, dilation, or sphincterotomy. Management of this complication may consist only of careful observation; may require transfusions or possibly surgery.
• Medication Phlebitis - Medications used for sedation may irritate the vein into which they are injected. This causes a red, painful swelling of the vein and surrounding tissue. The area could become infected. Discomfort in the area may persist up to several months.
• Respiratory Depression - The sedation used for this procedure will occasionally suppress breathing. Assisted breathing may be necessary until the sedation wears off.
• OTHER POTENTIAL RISKS include drug reactions and complications from other diseases you may already have. Instrument failure and death are extremely rare but remain remote possibilities. You must inform your physician of any allergies and medical problems.

Practical Alternatives

The PRACTICAL ALTERNATIVES TO THIS PROCEDURE: Although gastrointestinal endoscopy is an extremely safe and effective means of examining the gastrointestinal tract, it is not 100% accurate in diagnosis. In a small percentage of cases, a failure to diagnose or misdiagnose may result. Other diagnostic and therapeutic procedures, such as medical treatment, x-ray and surgery are available. Another option is to choose no diagnostic studies and/or treatment. Your physician will be happy to discuss these options with you.

I understand that during the course of the procedure described above, it may be necessary or appropriate to perform additional procedures that are unforeseen or not known to be needed at the time this consent is given. I consent to and authorize the persons described herein to make the decisions concerning such procedure. I also consent to and authorize the performance of such additional procedures as deemed necessary or appropriate.

I consent to diagnostic studies, tests, x-ray examinations, and any other treatment or courses of treatment relating to the diagnosis or procedure described herein. I consent to the use of IV sedation and understand the risks are those associated with the procedure itself as listed above. The options have also been explained to me. I consent that any tissues or specimens removed from my body in the course of any procedure may be tested or retained for scientific or teaching purposes, then disposed of within the discretion of the physician, facility or other health care provider. I understand that the physician, medical personnel, and other assistants will rely on statements about the patient, the patient's medical history and other information in determining whether to perform the procedure or the course of treatment for the patient's condition and in recommending the procedure which has been explained.

I understand that the practice of medicine is not an exact science, that NO GUARANTEES OR

ASSURANCES HAVE BEEN MADE TO ME concerning the results of this procedure.

BY SIGNING THIS FORM, I ACKNOWLEDGE THAT THE RISKS, BENEFITS, AND ALTERNATIVES TO

THE ABOVE PROCEDURE HAVE BEEN EXPLAINED TO ME, THAT I HAVE READ OR HAD THIS FORM

READ AND/OR EXPLAINED TO ME IN GENERAL TERMS, THAT I FULLY UNDERSTAND ITS CONTENTS,

THAT I HAVE BEEN GIVEN AMPLE OPPORTUNITY TO ASK QUESTIONS AND THAT THE QUESTIONS HAVE

BEEN ANSWERED SATISFACTORILY. ALL BLANKS OR STATEMENTS REQUIRING COMPLETION WERE

FILLED IN AND ALL STATEMENTS I DO NOT APPROVE OF WERE STRICKEN BEFORE I SIGNED THIS

FORM. I ALSO HAVE RECEIVED ADDITIONAL INFORMATION, INCLUDING BUT NOT LIMITED TO, THE

MATERIALS LISTED BELOW, RELATED TO THE PROCEDURE DESCRIBED HEREIN.

I voluntarily request and consent for my physician, and any other physician(s), and such associates, assistants or other medical personnel involved in performing such procedure(s) to perform the procedures(s) described or referred to herein.

ANESTHESIA CONSENT

REQUEST FOR THE ADMINISTRATION OF ANESTHESIA

TO THE PATIENT:

I have a general understanding of the procedure to be performed by my physician. I understand anesthesia services are requested or needed for the procedure. I consent to the administration of anesthesia as required for the procedure. I understand and acknowledge that all forms of anesthesia involve some risks and side effects, and the anesthesia provider can make no guarantees or promises concerning the results or outcome of the anesthesia plan of care. I acknowledge that impairment of full mental alertness may persist for several hours following the administration of anesthesia, and I will avoid making decisions or taking on activities, which depend on full concentration or judgment during this period.

It has been explained to me that all forms of anesthesia have some risks and side effects.  Although rare, unexpected severe complications can occur.

Possible anesthetic complications include but are not limited to, infection, bleeding, drug interactions, allergic reactions, dental damage, stroke, brain damage, heart attack, cardiac arrest, or death. Complications may require hospitalization.  I understand that these risks apply to all forms of anesthesia; additional or specific risks are identified below, as they apply to each type of anesthesia.

I understand the section below details the types of anesthesia to be used for my procedure. I understand the anesthetic technique is determined by many factors including my physical condition, the procedure performed, the physician preference, anesthesia provider care of plan, or my own desires. I also consent to an alternative type of anesthesia, if necessary, as deemed appropriate by the anesthesia provider and physician.

GENERAL ANESTHESIA: a controlled, drug-induced state of unconsciousness, accompanied by partial or complete loss of protective reflexes, including an inability to independently maintain an airway and/or respond purposefully to physical stimulation or verbal command.  May require placement of a breathing tube in the windpipe or another breathing device.  Risks include, but not limited to, mouth or throat pain, hoarseness, injury to mouth or teeth, awareness of intraoperative events, injury to blood vessels, aspiration, and pneumonia.

DEEP SEDATION: a controlled, drug-induced state of depressed consciousness from which the patient is not easily aroused, which may be accompanied by partial loss of protective reflexes, including the ability to maintain an open airway independently and/or respond purposefully to physical stimulation or verbal commands. Risks include, but not limited to, infection, mouth or throat pain, hoarseness, injury to mouth or teeth, aspiration, dizziness, nausea, or vomiting can occur.

MONITORED ANESTHESIA CARE (MAC): Anesthesia providers are present and able to provide indicated care based on my response to the procedure. Medications utilized may be sedatives, narcotics, and/or anesthetics and the degree of sedation or anesthesia cannot be specified ahead of time.

I understand the possible risk and complications of the planned anesthesia care as they have been explained to me. I have had the opportunity to ask questions, and I understand what has been explained. I hereby consent to the anesthetic(s) above and authorize the credentialed anesthesia providers of this facility to provide the outlined anesthesia plan. I further understand and certify for my own safety that I have a responsible adult to take me home after my procedure.

These consents will be electronically signed at Cape Health or Fort Myers Surgery Center.