ENDOSCOPY CONSULTANTS, LLC
INFORMED CONSENT FOR SPECIAL PROCEDURES
1. I acknowledge that I will undergo the following procedure(s), which is/are checked below, and has/have been described to me: (MARK PROCEDURE AND IV SEDATION IF INDICATED)
Percutaneous liver biopsy Collection of liver tissue performed with a special needle inserted into the liver. The skin is cleansed with bacteriostatic solution to prevent infection, then the area is injected with a local anesthetic to reduce discomfort. A small nick is made in the skin and the biopsy is performed following very brief insertion of a special needle attached to a syringe. It may be necessary to perform the actual biopsy more than once to collect a sufficient specimen of liver tissue suitable for diagnostic testing.
Abdominal paracentesis Removal of abdominal fluid for testing and/or relief of distension. The skin is cleansed with bacteriostatic solution to prevent infection, then the area is injected with local anesthetic to reduce discomfort as the needle is inserted into the abdominal wall. A small nick is made in the skin and the fluid may be removed through the needle/catheter device placed inside the fluid-filled abdominal cavity.
IV sedation Use of medication intravenously to maintain comfort during procedure. This is rarely needed for the above listed procedures.
2. Known Risks of these Procedures: • Injury to the lining of the respiratory or digestive tract caused by the needle which may result in perforation of bowel or other intra-abdominal structure, rarely resulting in leakage into the body cavities, or extremely rarely collapse of the lung on the right side (liver biopsy only). If this occurs, a surgical or drainage procedure to close the leak and drain the region may be necessary. • Bleeding may be a complication of biopsy or any other instrumentation. This complication may require only careful observation (only) or may require transfusions or possibly a surgical procedure. • There are additional risks such as drug reactions, heart rhythm disturbances, and complications incidental to other disease(s) you may have. • Other risks include: death, respiratory arrest, cardiac arrest, brain damage, disfiguring scar, paraplegia or quadriplegia, paralysis or partial paralysis, loss or loss of function of any limb or organ, severe loss of blood, allergic reaction, and infection. • When IV sedation is used, the risks of an allergic reaction, loss of protective reflexes or respiratory complications exist.
PATIENT NAME [LABEL}
1 Informed Consent – liver bx paracentesis 8.2004
3. I hereby voluntarily authorize Dr. and such assistants as may be selected by him/her to perform:
Percutaneous liver biopsy Abdominal paracentesis IV sedation
In conjunction with the procedure identified above, I acknowledge that I have been informed in general terms of the following: • Diagnosis of the condition requiring procedure • Nature and purpose of the procedure as reflected on Page 1 • Material risks of the procedure as reflected on Page 1, Paragraph 2 • Likelihood of success of procedure • Practical alternatives to procedure • Prognosis if procedure is rejected
4. Any tissue or specimen obtained during this procedure may be retained, preserved or disposed of by, or under the direction of the pathology department examining the specimen(s).
5. I understand the above information regarding my procedure and acknowledge that I have been informed of the risks and possible complications. I am aware that the practice of medicine and surgery is not an exact science, and I acknowledge that no guarantees have been made to me concerning the results of the procedure(s) identified above. If any unforeseen condition arises during the procedure(s) calling for additional procedures, operations, or medications (including anesthesia and blood transfusion), I further request and authorize the physician to do whatever he/she deems advisable in my interest. This consent shall also extend to the treatment of all conditions which may arise during the course of such procedures including those conditions which may be unknown or unforeseen at the time this consent is obtained.
Patient Signature (or Guardian) Date/Time Relationship to Patient
Physician Signature Date/Time
Witness Signature Date/Time
PATIENT NAME [LABEL]
2 Informed Consent – liver bx paracentesis 8.2004