INFORMED CONSENT

INFORMED CONSENT

COLONOSCOPY

Please read this information carefully and if you have additional questions, feel free to discuss them with a member of our team prior to the procedure.

What is the purpose of a colonoscopy?
Colonoscopy is used to examine the lining of the large intestine (colon) and, if necessary, to take biopsy specimens (tiny bits of tissue) or remove polyps (abnormal growths that can become a cancer). Since colon cancer starts as a polyp, removal of those polyps prevents colon cancer. Cancer of the colon is the second leading cause of cancer related death for men and women in United States.

How is a colonoscopy done?
Colonoscopy is a test using a video camera on a long flexible tube designed to pass through your large bowel looking for abnormalities. The image from the camera is projected on a video monitor and the doctor steers the scope around your bowel. During the procedure the tube needs to pass around some bends in your bowel, and requires that air be introduced into your bowel, to help with visualization. Sedation is provided to minimize any discomfort you may have as a result of these maneuvers. Up to 30% of the time polyps are found. Most can be removed through the colonoscope at the time of the procedure. Polyps can be snared (lassoed with a wire loop) and removed. A small piece of tissue (biopsy) may also be removed to send for analysis to determine if the abnormality was benign (noncancerous) or malignant (cancerous). Biopsies and polypectomies do not cause any discomfort.

What can I expect during the colonoscopy?
Colonoscopy is usually well tolerated and rarely causes much pain. An intravenous will be started, so that the doctor may give you medication to make you feel relaxed and sleepy. While you are lying on your side, the tube is inserted into the rectum and gradually advanced through the colon. The doctor will examine the lining of the bowel, perform any necessary biopsies or polyp removal, then the tube is slowly withdrawn. You may feel uncomfortable during the test from time to time because air is used to inflate the bowel.

What are possible complications? (IMPORTANT)
While all the physicians that participate in the program are experienced and use the utmost caution, there is a well-documented risk associated with the procedure. However the risk of not getting screened is far more significant (1 in 20 lifetime risk for colon cancer).

• Bowel Preparation: There is a risk of dehydration with the bowel preparation. Drinking lots of fluids with electrolytes (like sports drinks) helps to increase the quality of the bowel preparation and also decreases the risks of dehydration and the associated risks.
• Drug reaction: It is possible, although extremely unlikely, that you will develop a reaction to one of the medications. The reaction is usually mild and in the form of rashes, hives, or itching at the site of the IV catheter.
• Perforation: Puncture of the wall of the colon is very rare (1:1000 chance). If it occurs surgery might be necessary to repair the perforation and you will be hospitalized.
• Bleeding: There is a small risk of significant bleeding (1:100 chance) if a polyp is removed. Bleeding can occur up to 10 days later. This usually settles without further treatment and rarely blood transfusions or surgery may be required. Contact your physician or go to the emergency department if you have rectal bleeding of more than one half cup.
• Missed abnormalities: Some polyps or abnormalities might be missed. The risks are significantly higher if your bowel is not cleaned properly.

What can I expect after the colonoscopy?
Your pulse, respiration and blood pressure will be checked while you are in the recovery room. You may feel bloated or have some cramping. Due to the sedation given, your judgment and reflexes may be impaired for the rest of the day. Someone must accompany you home. You cannot drive or operate machinery for 12 hours post sedation. Unless your doctor tells you otherwise, you may resume your regular diet after leaving the facility. The doctor will explain the results of the examination to you and provide you with a written summary. These findings will also be communicated to your referring doctor.

UPPER GI ENDOSCOPY / EGD

Please read this information carefully and if you have additional questions, feel free to discuss them with a member of our team prior to the procedure.

What is the purpose of an upper GI endoscopy / EGD?
You are considering a procedure called upper endoscopy, which is the examination of your esophagus (food pipe), stomach, and duodenum (first part of the small intestine) with a flexible, lighted scope.This procedure is most often done for:

• upper abdominal pain or discomfort
• gastroesophageal reflux disease (acid reflux or heartburn)
• difficulty swallowing
• persistent nausea and vomiting
• bleeding from the upper gastrointestinal tract
• unexplained anemia or weight loss
• follow up of previous abnormal findings, such as Barrett’s esophagus (a precancerous condition), ulcers or polyps
• further investigation of abnormalities found on X-ray studies, such as an upper GI or CT scan.

How is an Upper GI Endoscopy Performed?
Patients may receive a local, liquid anesthetic that is gargled or sprayed on the back of the throat. The anesthetic numbs the throat and calms the gag reflex. An intravenous (IV) needle is placed in a vein in the arm if a sedative will be given. Sedatives help patients stay relaxed and comfortable. While patients are sedated, the doctor and medical staff monitor vital signs. During the procedure, patients lie on their back or side on an examination table. An endoscope is carefully fed down the esophagus and into the stomach and duodenum. A small camera mounted on the endoscope transmits a video image to a video monitor, allowing close examination of the intestinal lining. Air is pumped through the endoscope to inflate the stomach and duodenum, making them easier to see. Special tools that slide through the endoscope allow the doctor to perform biopsies, stop bleeding, and remove abnormal growths. During the upper endoscopy, various procedures to aid in diagnosis or treatment may be performed:

• A biopsy, which is a small tissue sample about the size of a match head, may be taken.
• If a polyp is noted, the Physician may choose to remove it using a small instrument that is passed through the scope.
• Abnormal bleeding may be treated with cauterization, injection of constricting medicines, metal clips or rubber bands.
• Strictures (narrowed areas) may be dilated (stretched) with balloons or tapered tubes.
• A pH probe can be placed to determine amount of acid reflux and correlate symptoms with acid reflux.
• Ingested foreign objects may be removed with a variety of small instruments passed through the scope.
• Feeding tubes can be placed for long term nutritional support.

What are possible complications? (IMPORTANT)
Upper endoscopy performed by a trained physician is generally a very safe procedure, but, like any medical procedure, does carry some possible risks:

• Major complications such as bleeding or perforation (making a hole or tear in the upper gastrointestinal tract) occur in less than 3 out of 10,000 upper endoscopy procedures and may require surgery.Bleeding and perforation are more likely when large polyps are removed, dilation is performed (less than 4 out of 1000 dilations), foreign objects are removed, or feeding tubes are placed.
• Bleeding may be more likely to occur if you take certain medications that thin the blood: Coumadin (warfarin), Eliquis (apixaban), Pradaxa (dabigatran), Xarelto (rivaroxaban), Lovenox (enoxaparin), Arixtra (fondaparinux), heparin, Plavix (clopidogrel), Brilinta (ticagrelor), Effient (prasugrel) aspirin products, or arthritis medications. Be sure to discuss with the physician or his staff what to do if you take any of these medications.
• Uncommonly, aspiration (inhaling food or liquids into the lungs) can occur, possibly causing pneumonia or difficulty breathing.The risk of aspiration can be minimized by not eating or drinking before the procedure.(See separate instructions)
• Reactions to the sedative medications given during the procedure may occur, although this is uncommon.Please notify the physician or his staff if you have any medication allergies or previous unusual reactions to sedatives.Also, you can undergo the procedure without sedation.Be sure to notify The Physician if you prefer no sedation.
• Very rarely, there can be unforeseen complications that include breathing or heart problems, infection, damage to teeth or dental work, injury to other internal abdominal organs, or even death.
• Sometimes it is not possible to examine the entire upper gastrointestinal tract and additional testing may be required.It is also possible to miss cancer, although this is rare.

Depending on the reason for your upper endoscopy, you should also know that there may be potential risks to not doing the procedure, such as delayed diagnosis of cancer or missed diagnosis of disease.

There are alternatives to upper endoscopy:

The upper gastrointestinal tract can be examined with a barium upper GI X-ray examination.If abnormalities are found, an upper endoscopy may be required for further investigation.

Polyps, bleeding and strictures can be treated with surgery.Foreign objects may be removed and feeding tubes may be placed surgically.

Sometimes bleeding can be treated and feeding tubes can be placed with a radiologic procedure.

What am I consenting to?
You acknowledge that you have :

1. read and fully understand what is involved in a colonoscopy and an upper endoscopy procedure; including the benefits and risks
2. that you understand that there is a risk of complication
3. that you would like to proceed to schedule for either one or both procedures.

If you have any questions about the information contained in this document please contact the program at (855) 542 6566. We would be happy to assist you or provide clarification. You will have an opportunity before the procedure to discuss your concerns with a physician or nurse at your request.

Your signature acknowledges that you have read the informed consents for both procedures and grants your consent to the procedure(s).