Saturday, December 11, 2010

Standard Consent form for Tympanoplasty


CONSENT INFORMATION – PATIENT COPY

TYMPANOPLASTY

PLEASE READ THIS SHEET BEFORE YOU CONSENT FOR YOUR PROCEDURE

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

A tympanoplasty is a surgical procedure that repairs or reconstructs the eardrum (tympanic membrane) to help restore normal hearing. This procedure may also involve repair or reconstruction of the small bones behind the tympanic membrane (ossiculoplasty) if needed. Both the eardrum and middle ear bones (ossicles) need to function well together for normal hearing to occur.

What are the indications for a tympanoplasty? 

This procedure is usually not performed (or needed) in children under four years of age. A tympanoplasty is recommended when the eardrum is torn (perforated), sunken in (atelectatic), or otherwise abnormal and associated with hearing loss. Abnormalities of the ear drum and middle ear bones can occur through injury, otitis media, congenital (at birth) deformities, or chronic ear conditions such as a cholesteatoma.


What are the signs & symptoms of a ruptured eardrum? 

A ruptured eardrum can be painful, particularly at first. Signs and symptoms may include:
* Sharp, sudden ear pain or discomfort
* Clear, pus-filled or bloody drainage from your ear
* Sudden decrease in ear pain followed by drainage from that ear
* Hearing loss
* Ringing in your ear (tinnitus)

How successful is tympanoplasty in restoring normal hearing? 

Return to a normal range of hearing after tympanoplasty is dependent upon the extent of the abnormality. Surgeries that involve repair of the eardrum only usually have a success rate of 85-90%. A second operation may be necessary in some cases if the hearing is not restored to an acceptable level.

Are there any other options aside from tympanoplasty?

Tympanoplasty in most cases is an elective procedure, meaning that it can be scheduled whenever the patient is ready to have it done. Another option instead of this procedure includes the use of a hearing aid. When the tympanic membrane has a hole (perforation) in it, earplugs are usually recommended to protect the middle ear from infection. In a few cases, such as a significant infection or a cholesteatoma, this procedure may prevent more significant damage to the ear and the surgery may need to be performed more urgently.

What is done in preparation for a tympanoplasty? 

Usually other ear, nose, and throat conditions are treated before a tympanoplasty is considered. For example, if an adenoidectomy is indicated, this surgery is usually completed before tympanoplasty.
Otitis Media of any type should not be present at the time of surgery, as infections in the ear make the operation much more difficult and may ruin the reconstruction. If your surgeon has suggested certain medications prior to surgery, these should be done without exception to ensure a successful outcome. A hearing test is performed to document any hearing deficiency. The more significant the hearing loss, the sooner the procedure should be performed. The eardrum will also be examined before surgery using a special operating microscope.

What to expect in hospital? 

Before surgery you will talk to your surgeon about the operation and you will be asked to sign a Consent Form either for yourself, or on behalf of your child. This confirms that you understand the risks, benefits and possible alternatives to the procedure and have given your permission for it to go ahead.
Fasting instructions must be followed before a general anesthetic. Typically, you must not eat or drink for about six hours. However, some anesthetists allow occasional sips of water until two hours beforehand.

How is Tympanoplasty performed? 

A tympanoplasty is performed with the patient fully asleep (under general anesthesia). A surgical cut (incision) is usually made behind the ear, the ear is moved forward, and the eardrum is then carefully exposed. The eardrum is then lifted up (tympanotomy) so that the inside of the ear (middle ear) can be examined. If there is a hole in the eardrum, it is cleaned (debrided) and the abnormal area can be cut away. A piece of fascia (tissue under the skin) from the temporalis muscle (behind the ear) is then cut and placed under the hole in the ear drum to create a new intact ear drum. This tissue is called a graft. The graft allows your child's normal eardrum skin to grow across the hole.
If needed, reconstruction of the middle ear bones (ossiculoplasty) or Cholesteatoma removal may also be performed at this time.

Post operative care: 

Some soreness in the jaw is common after a Tympanoplasty.  To ease the pain and quicken the healing process, your doctor can advise that you keep the ear dry and avoid air travel and contact with people who have colds.  Water in the ear can often cause problems so doctors recommend that you don’t take showers, or even walk in the rain for the first 5-6 days.  The graft should seal the hole within two weeks.

Length of Tympanoplasty: 

This surgery usually requires an overnight hospital stay. The patient usually has a dressing (large bandage) over the surgical site. This is removed the next morning and the patient is discharged home. Occasionally, in older children, or those undergoing a less involved procedure, same-day surgery is possible. Eardrops may be prescribed after discharge.

The most important part of this surgery for the parent is your part in restricting activity as outlined by your surgeon

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) Ringing in the ear (tinnitus) or dizziness may occur and may be temporary/ permanent
(c) Partial loss of hearing or total loss hearing due to inner ear injury may rarely occur and may be permanent
(d) Facial nerve palsy. Temporary or permanent paralysis of the muscles of the face may rarely occur
(e) Failure to improve hearing. An improvement in hearing may not be apparent despite the surgery being successful in repairing the hole reconstructing the chain of bones
(f) Failure of the repair. There may be persistence of the tympanic membrane perforation or ossicular chain damage which may require further surgery
(g) Intracranial complications are rare.
(h) Altered sensation of taste may occasionally occur
(i) Temporary loss of sensation to ear (pinna).
(j) Abnormal scar tissue formation. This may result in a thickened, wide red scar which may require further surgery
10. 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: TYMPANOPLASTY


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- "Tympanoplasty” 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) Ringing in the ear (tinnitus) or dizziness may occur and may be temporary/ permanent
(c) Partial loss of hearing or total loss hearing due to inner ear injury may rarely occur and may be permanent
(d) Facial nerve palsy. Temporary or permanent paralysis of the muscles of the face may rarely occur
(e) Failure to improve hearing. An improvement in hearing may not be apparent despite the surgery being successful in repairing the hole reconstructing the chain of bones
(f) Failure of the repair. There may be persistence of the tympanic membrane perforation or ossicular chain damage which may require further surgery
(g) Intracranial complications are rare.
(h) Altered sensation of taste may occasionally occur
(i) Temporary loss of sensation to ear (pinna).
(j) Abnormal scar tissue formation. This may result in a thickened, wide red scar which may require further surgery

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………………………………………

PREFERENCES

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……………………………………

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