Consent information for Myringoplasty

CONSENT INFORMATION – PATIENT COPY

MYRINGOPLASTY

PLEASE READ THIS SHEET BEFORE YOU CONSENT FOR YOUR PROCEDURE

This information sheet provides general information to a person having a Myringoplasty. 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 “Myringoplasty”?

A myringoplasty is a surgical procedure indicated as a treatment option for a perforated eardrum when the perforation has failed to heal on its own. It involves using a piece of grafted skin taken from another part of the anatomy and placing and securing it over the hole.

What causes a perforated ear drum?
Perforation of the ear drum can occur following an infection of the ear where fluid and infectious material has collected causing pressure to build-up, resulting in a split or tear to the ear drum. Other possible reasons for a perforation of the

eardrum include trauma following insertion of a foreign body or cleaning implement into the ear, sudden changes in atmospheric air pressures when the ear cannot equalize its own pressures quickly enough, or because of exposure to sudden and very noises.
Why do I need an operation?
In most cases of eardrum perforation, the hole will simply seal itself and no long-term effects are experienced. If this does not happen however, the hole remains open, leaving the ear vulnerable to further infections, which may be potentially very serious if left untreated.
What improvements can I expect from a myringoplasty?
This varies a lot from person to person and depends on what symptoms you have to start with. Possible benefits include:
* You may get a mild improvement in your hearing.
* you are less likely to get middle ear infections when you get your ears wet
* less ear discharge
Are there any alternatives?

You cannot take tablets or medicines to close a hole in your eardrum. Sometimes, small holes close by themselves if left. If not, then a surgery is a must.

Preparation for surgery:

A few weeks before the operation, you will be contacted by the hospital with a date and time for the operation. You will be told about when to stop eating and what to bring to bring to hospital.
You will have a chance to further discuss the risks, and then will be asked to sign a consent form. If you smoke, you should aim to stop at least 24 hours before your operation.
If you decide you don’t want the operation, you should contact your doctor.
What is involved in the operation?
Performed under a general anesthetic, the surgeon selects the best piece of skin for the graft; this is usually taken from just above the ear itself. This area will then be stitched using either absorbable stitches that will dissolve by themselves, or with non-absorbable material that will be removed around seven days following the surgery.
Using very small instruments, the surgeon then places this graft onto the underside of the eardrum and secures it using an adhesive substance that will hold the graft in place until it has attached itself to the new surface. The ear may then be packed with some gauze soaked in anti-biotic drops used to help prevent an infection, and the whole ear is then protected using a cotton dressing.
If the operation has been successful and there have been no complications, discharge can be expected 24 to 48 hours later. Although this may sound like a tricky and very delicate procedure, the surgeons that perform this operation are very highly trained and will be confident and competent that they can carry it out.
What to expect after the surgery?
Following the operation, expect some discomfort from the packing, along with hearing impairment whilst the dressings are in place. Pain can be controlled using prescription drugs or with paracetamol. Try not to blow your nose or allow water to enter your ears until the packing has been removed. The packing will normally be removed during a follow-up appointment around three weeks later, when the eardrum will be assessed.
At Home:
* Take two painkilling tablets every six hours to control any pain or discomfort.
* Be sure to keep the ear dry and do not go swimming.
* You should also avoid flying until the doctor confirms that the graft has successfully closed the hole. This is because changes in the ear pressure especially during take off and landing can push the graft out of place.
* You may feel rather tired for a week or so, but this will steadily improve. You should be able to go back to work after 10 days, but you must keep your ear dry.
* It will be better for somebody to drive you home after the operation or for you to take a taxi.
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) Bleeding or infection in the ear or in the wound.
(b) Failure of the repair. Persistence of the tympanic membrane perforation may occur and may require further surgery.
(c) Recurrence of the tympanic membrane perforation may occur and may require further surgery.
(d) Cholesteatoma.
(e) Ringing (tinnitus) or imbalance/dizziness may occur and may be temporary permanent.
(f) Failure to improve hearing. An improvement in hearing may not be apparent despite the surgery being successful in repairing the hole.
(g) Altered sensation of taste may occasionally occur on one side.
(h) Sensation to the ear (pinna) or the ear may stick out.
(i) Partial loss of hearing or total loss hearing may rarely occur.
(j) Temporary or permanent paralysis of the muscles of the face may rarely occur.
(k) In some people, the wound can become thick and red and the scar may be painful.
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: MYRINGOPLASTY


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- “Myringoplasty” 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) Bleeding or infection in the ear or in the wound.
(b) Failure of the repair. Persistence of the tympanic membrane perforation may occur and may require further surgery.
(c) Recurrence of the tympanic membrane perforation may occur and may require further surgery.
(d) Cholesteatoma.
(e) Ringing (tinnitus) or imbalance/dizziness may occur and may be temporary permanent.
(f) Failure to improve hearing. An improvement in hearing may not be apparent despite the surgery being successful in repairing the hole.
(g) Altered sensation of taste may occasionally occur on one side.
(h) Sensation to the ear (pinna) or the ear may stick out.
(i) Partial loss of hearing or total loss hearing may rarely occur.
(j) Temporary or permanent paralysis of the muscles of the face may rarely occur.
(k) In some people, the wound can become thick and red and the scar may be painful.

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……………………………………