Download Gastrointestinal Endoscopy Informed Consent

PLACE LABEL HERE
GASTROINTESTINAL ENDOSCOPY
INFORMED CONSENT
(This form is designed to comply with the Georgia Informed Consent Law O.C.G.A. 31-9-6.1)
The diagnosis requiring this procedure is: _________________________________________________
Explanation of Procedure:
Endoscopy is the direct visualization of the digestive tract’s inside lining. The digestive tract is visualized with a lighted flexible
tube. During the inspection of the lining, certain diagnostic or therapeutic interventions may be performed. A sample of tissue may
be taken (a biopsy/needle aspiration). A polyp may be removed (a polypectomy.) A brushing of mucosal lining may be obtained
for evaluation for abnormal cells, or cytology. Fluid may be obtained for chemical analysis. Pictures may be taken of digestive
tract during the procedure.

Esophagogastroduodenoscopy (EGD) – The examination of the esophagus, stomach and duodenum.

Percutaneous Endoscopic Gastrostomy/Percutaneous Endoscopic Jejunostomy (PEG/PEJ) – The PEG is the
placement of a feeding tube through the abdominal wall into the stomach as a possible route for nutrition. The PEJ is the
placement of a feeding tube through the abdomen into the jejunum for a route to deliver nutrition. The tube is placed using a
lighted flexible scope to visualize the stomach and through an incision made in the abdominal wall.

Endoscopic retrograde cholangiopancreatography (ERCP) – The examination of the pancreas and biliary tract for disease,
stent placement, dilation, stone removal, drainage, or cautery (a small electrical cut) of the bile duct or pancreatic duct
opening.

Dilation – Dilation of a stricture, 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.

Small Bowel Enteroscopy- Examination of the small intestine beyond the second portion of the duodenum, not including the
ileum.

Bravo pH Monitoring –Placement of monitoring device in lower esophagus during EGD.

Banding- Placement of a rubber band(s) around an enlarged vein.

Esophagoscopy with HALO- Examination of esophagus with radiofrequency ablation of abnormal cells.

Endoscopic Ultrasound- Visual examination of the upper or lower intestinal tract using a lighted video endoscope with an
ultrasound probe.
Principal Risks and Complications of Gastrointestinal Endoscopy – Gastrointestinal endoscopy is generally a low risk procedure.
However, all of the below complications are possible. YOU MUST ASK FOR YOUR PHYSICIAN IF YOU HAVE UNANSWERED
QUESTIONS ABOUT YOUR TEST.
1. 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.
2. 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 possible surgery.
3. Missed Polyp or Significant Neoplasm
4. Medication Phlebitis – Medications used for sedation may irritate the vein in 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.
5. Respiratory Depression – The sedation used for this procedure will occasionally suppress breathing. Assisted breathing may be
necessary until the sedation wears off.
6. Pancreatitis – Inflammation of the pancreas is a rare complication of ERCP and is usually mild in nature however it can be lifethreatening in rare instances.
7. 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
*2-15393*
2
FORM 2-15393 REV. 09/2016
Page 1 of
PLACE LABEL HERE
GASTROINTESTINAL ENDOSCOPY
INFORMED CONSENT
*2-15393*
2
FORM 2-15393 REV. 09/2016
Page 2 of
PLACE LABEL HERE
GASTROINTESTINAL ENDOSCOPY
INFORMED CONSENT
The likelihood of success of this procedure is:  Good
 Fair
 Poor
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 mis-diagnose may result. Other diagnostic or therapeutic procedure, 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.
If I choose not to have the above procedure, my prognosis (future medical condition) is:  Unknown
 Poor
 Good
I understand that during the course of the procedure described above, it may be necessary or appropriate to perform additional
procedures which 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 procedures. I also consent to and authorize the performance of such
additional procedures as they deem 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
procedures 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 to the use of blood and blood products as deemed
necessary. The risks of exposure to AIDS, hepatitis or other infectious diseases as well as the need for and available alternatives have
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 IT’S CONTENTS, THAT I HAVE BEEN GIVEN AMPLE OPPORTUNITY TO ASK
QUESTIONS AND THAT 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 hereby voluntarily request and consent for Dr. _____________________________, as my physician, and any other physician(s), and
such associates, assistants or other medical personnel involved in performing such procedure(s), to perform the procedure(s) described
or referred to herein.
Additional materials used during the informed consent process for this procedure include:
___________________________________________________________________________________________________________
__________ __________ ________________________________ ____________________________
Date
Time
Person giving consent
Relationship to patient
Patient unable to sign because of _____________________________________________________________
Responsible Practitioner’s Statement:
I have reviewed the contents of this form, including the risks, benefits and alternatives to the proposed procedure, with the patient or the
patient’s decision-maker, and have provided the patient/decision-maker with an opportunity to ask questions.
___________
Date
______________
Time
FORM 2-15393 REV. 09/2016
__________________________________________
Physician Signature
___________
PID Number
Page 3 of 3