Friday, July 1, 2011

Consent form for Oesophagoscopy

CONSENT INFORMATION – PATIENT COPY

OESOPHAGOSCOPY (also known as Gastroscopy)

PLEASE READ THIS SHEET BEFORE YOU CONSENT FOR YOUR PROCEDURE

This information sheet provides general information to a person having an Oesophagoscopy. It does not provide advice to the individual. It is important that the content is discussed between the patient and the concerned doctors who understand the level of fitness and medical condition.

What is the “Oesophagus”?
The Oesophagus is the muscular tube that carries food and drink from the back of the throat down to the stomach. The oesophagus is also called the gullet. It passes behind the voice box. It has a delicate lining rather like skin, called mucous membrane. Secretions from the mucous membrane lubricate food as it passes from the mouth to the stomach.


There is a weak valve at the lower end of the oesophagus, where it enters the stomach. This valve is called the cardiac sphincter. The cardiac sphincter prevents food, drink and stomach juices from flowing back up into the oesophagus, unless

you vomit. The oesophagus is part of the digestive system, called the gastrointestinal tract.

What is Oesophagoscopy?
This is a procedure where the Doctors pass a tube into your mouth and down into your gullet to allow direct inspection of all areas of the gastro intestinal system. This allows him to take samples and determine the causes of problems the patient may have been experiencing. It is also used to determine the extent of existing conditions.
Who needs an Oesophagoscopy?
An Oesophagoscopy may be advised if you have symptoms such as recurring indigestion, recurring heartburn, pains in the upper abdomen, repeated vomiting, difficulty swallowing, or other symptoms thought to be coming from the upper gut. The sort of conditions which can be confirmed (or ruled out) include:
* Oesophagitis (inflammation of the oesophagus). The operator will see areas of redness on the lining of the oesophagus.
* Duodenal or stomach ulcer. An ulcer looks like a small, red crater on the inside lining of the duodenum or stomach.
* Duodenitis (inflammation of the duodenum).
* Gastritis (inflammation of the stomach).
* Cancer of the stomach or oesophagus.
* Various other rare conditions.
Are there any alternatives? (Please consult with your doctor about it)
X rays are not very good for showing the inside of the oesophagus. It is possible to use a barium swallow or a barium meal to outline the oesophagus on an x-ray. These x-ray examinations outline the oesophagus using barium liquid, which shows up on x-rays. Oesophagoscopy is the suitable technique used for examining the upper part of the oesophagus. However if you need your lower oesophagus or stomach looked at then a fibreoptic gastro-oesophagoscope is used.
What preparation do I need to do?
You should get instructions from the hospital department before your test. The sort of instructions given commonly includes:
* You should not eat for 4-6 hours before the test. The stomach needs to be empty. (Small sips of water may be allowed up to two hours before the test.)
* If you have a sedative you will need somebody to accompany you home.
* Advice about medication which may need to be stopped before the test.
What happens during the procedure?

Oesophagoscopy is usually done as an outpatient 'day case'. It is a routine test which is commonly done. The doctor may numb the back of your throat by spraying on some local anesthetic. You may be given a sedative to help you to relax.
You lie on your side on a couch. You are asked to put a plastic mouth guard between your teeth. This protects your teeth and stops you biting the endoscope. The doctor will then ask you to swallow the first section of the endoscope. Modern endoscopes are quite thin and easy to swallow. The doctor then gently pushes it further down your oesophagus, and into your stomach and duodenum. The video camera at the tip of the endoscope sends pictures to a screen. The doctor watches the screen for abnormalities of the oesophagus, stomach and duodenum. Air is passed down a channel in the endoscope into the stomach to make the stomach lining easier to see. This may cause you to feel 'full' and want to belch.
The doctor may take one or more biopsies of parts of the inside lining of the gut - depending on why the test is done and what they see. This is painless. The biopsy samples are sent to the lab for testing, and to look at under the microscope. The endoscope is then gently pulled out.
An Oesophagoscopy usually takes about 10 minutes. However, you should allow at least two hours for the whole appointment to prepare, give time for the sedative to work (if you have one), for the Oesophagoscopy itself, and to recover. A Oesophagoscopy does not usually hurt, but it can be a little uncomfortable, particularly when you first swallow the endoscope.
How will I feel after the procedure?
After oesophagoscopy, you may find that your throat hurts. This is because of the metal tubes that are passed through your throat to examine the gullet. Any discomfort settles quickly with simple painkillers and usually only lasts a day or two.
Some patients feel their neck is slightly stiff after the operation.
What can I expect after an Oesophagoscopy?
Most people are ready to go home after resting for half an hour or so.
If you have had a sedative - you may take a bit longer to be ready to go home. You should not drive, operate machinery or drink alcohol for 24 hours after having the sedative. You will need somebody to accompany you home and to stay with you for 24 hours until the effects have fully worn off. Most people are able to resume normal activities after 24 hours.
The result from any biopsy may take a few days which can delay the report being sent. The doctor may also tell you what they saw before you leave.
General Risks of having the procedure:
These have been mentioned in the “Anesthesia Consent Form.” Please discuss this with your Anesthetist before signing the Anesthesia Consent Form.
What are the risks of the procedure?
While majority of patients have an uneventful procedure and recovery, few cases may be associated with complications. These are seen infrequently and not all the ones listed below are applicable to one individual. However it is important that you are aware of the complications/risks that may arise out of this procedure which are as below:
There are some risks/ complications, which include:
(a) Injury to the lips, teeth, gums or tongue. Dental injury may result in teeth being chipped, broken or dislodged.
(b) Perforation or rupture of the oesophagus. This may lead to a serious infection in the neck or chest which is life threatening. Surgery involving the neck and/or chest is usually required to repair the perforation and treat the infection and a prolonged stay in hospital will be required. This infection, or the surgery required to treat the perforation, may cause injury to the larynx (voice box) or the nerves controlling the larynx resulting in an abnormal voice.
(c) Voice change. The larynx (voice box) or the nerves controlling the larynx may be injured by the instruments used for the oesophagoscopy. Voice change may also result from perforation of the oesophagus as outlined above.

Consent Acknowledgement:
* The doctor has explained my medical condition and the proposed surgical procedure.
* I understand the risks of the procedure, including the risks that are specific to me, and the likely outcomes. The doctor has explained other relevant treatment options and their associated risks, the prognosis and the risks of not having the procedure.
* I have been given an Anesthesia Informed Consent Form.
* I have been given a Patient Information Sheet about the Condition, the Procedure, and associated risks.
* I was able to ask questions and raise concerns with the doctor about my condition, the procedure and its risks, and my treatment options.
* My questions and concerns have been discussed and answered to my satisfaction.
* I understand that the procedure may include a blood / blood product transfusion.
* I understand that if organs or tissues are removed during the surgery, that these may be retained for tests for a period of time and then disposed of sensitively by the hospital.
* The doctor has explained to me that if immediate life-threatening events happen during the procedure, they will be treated as appropriate.
* It has been explained to me, that during the course of or subsequent to the Operation/Procedure, unforeseen conditions may be revealed or encountered which may necessitate urgent surgical or other procedures in addition to or different from those contemplated. In such exigency, I further request and authorize the above named Physician / Surgeon or his designee to perform such additional surgical or other procedures as he or they consider necessary or desirable.
On the basis of the above statements,
I REQUEST TO HAVE THE PROCEDURE.
Name of Patient/Substitute Decision Maker…………………………………………….
Relationship …………………………………….
Signature………………………………………
Date………………………………………………
Name of the Witness…………………………
Relationship/Designation………………………
Signature………………………………………..
Date……………………………

INFORMED CONSENT: OESOPHAGOSCOPY


Patient Identification Label to be affixed here








A. INTERPRETER
An interpreter service is required.Yes______________No_______________
If Yes, is a qualified interpreter present.Yes_____________No___________

B. CONDITION AND PROCEDURE
The doctor has explained that I have the following condition:
(Doctor to document in patient’s own words)
_______________________________________________and I have been advised to undergo the following treatment/procedure____________________________________________________________________________________________________________________________________________________________
See patient information sheet- “Oesophagoscopy” for more
C.ANAESTHETIC
Please see your “Anesthesia Consent Form”. This gives you information of the General Risks of Surgery. If you have any concern, talk these over with your anesthetist.

D.RISKS OF THIS PROCEDURE
While majority of patients have an uneventful surgery/procedure and recovery, few cases may be associated with complications. These are seen infrequently and not all the ones listed below are applicable to one individual. However it is important that you are aware of the complications/risks that may arise out of this procedure which are as below:

There are some risks/ complications, which include:
(a) Injury to the lips, teeth, gums or tongue. Dental injury may result in teeth being chipped, broken or dislodged.
(b) Perforation or rupture of the oesophagus. This may lead to a serious infection in the neck or chest which is life threatening. Surgery involving the neck and/or chest is usually required to repair the perforation and treat the infection and a prolonged stay in hospital will be required. This infection, or the surgery required to treat the perforation, may cause injury to the larynx (voice box) or the nerves controlling the larynx resulting in an abnormal voice.
(c) Voice change. The larynx (voice box) or the nerves controlling the larynx may be injured by the instruments used for the oesophagoscopy. Voice change may also result from perforation of the oesophagus as outlined above.

SIGNIFICANT RISKS AND RELEVANT TREATMENT OPTIONS:F. SIGNIFICANT RISKS AND
The doctor has explained any significant risks and problems specific to me, and the likely outcomes if complications occur.
The doctor has also explained relevant treatment options as well as the risks of not having the procedure.
(Doctor to document in Medical Record if necessary. Cross out if not applicable. )

PATIENT CONSENT: CONSENT
I acknowledge that:
* The doctor has explained my medical condition and the proposed procedure. I understand the risks of the procedure, including the risks that are specific to me, and the likely outcomes.
* The doctor has explained other relevant treatment options and their associated risks. The doctor has explained my prognosis and the risks of not having the procedure.
* I have been given a Patient Information Sheet on Anesthesia.
* I have been given the patient information sheet regarding the condition, procedure, risks and other associated information.
* I was able to ask questions and raise concerns with the doctor about my condition, the procedure and its risks, and my treatment options. My questions and concerns have been discussed and answered to my satisfaction.
* I understand that the procedure may include a blood transfusion.
* I understand that if organs or tissues are removed during the surgery, that these may be retained for tests for a period of time and then disposed of sensitively by the hospital.
* The doctor has explained to me that if immediate life-threatening events happen during the procedure, they will be treated accordingly.
* I understand that photographs or video footage maybe taken during my operation. These may then be used for teaching health professionals. (You will not be identified in any photo or video).
* I understand that no guarantee has been made that the procedure will improve the condition, and that the procedure may make my condition worse.

On the basis of the above statements,
I hereby authorize Dr……………………………………………………………………and those he may designate as associates or assistants to perform upon me the following medical treatment, surgical operation and / or diagnostic / therapeutic procedure…………………………………………………………..

I REQUEST TO HAVE THE PROCEDURE

Name of Patient/Substitute Decision Maker…………………………………………….
Relationship …………………………………………………………………………………….
Signature……………………………………………Date……………………………………….

Name of the Witness…………………………………………………………………………
Relationship/Designation………………………………………………………………………
Signature……………………………………………Date………………………………………
FERENCES
INTERPRETER’S STATEMENT:
I have given a translation in……………………………………………………………………
Name of interpreter…………………………………………………………………………….
Signature……………………………………………Date………………………………………

DOCTOR’S STATEMENTS
I have explained
* The patient ‘s condition
* Need for treatment
* The procedure and the risks
* Relevant treatment options and their risks
* Likely consequences if those risks occur
* The significant risks and problems specific to this patient

I have given the Patient/ Guardian an opportunity to:
* Ask questions about any of the above matters
* Raise any other concerns, which I have answered as fully as possible.

I am of the opinion that the Patient/ Substitute Decision Maker understood the above information.

Name of doctor…………………………………………………………………………..
Designation………………………………………………………………………………
Signature………………………………………Date……………………………………





1 comment:

  1. Thanks for sharing sample consent form for oesophagoscopy patients... while reading this article it's very difficult to understand.

    ReplyDelete