Friday, July 1, 2011

Consent information for Stapectomy or Stapedotomy

CONSENT INFORMATION – PATIENT COPY
STAPEDECTOMY

PLEASE READ THIS SHEET BEFORE YOU CONSENT FOR YOUR PROCEDURE

This information sheet provides general information to a person having a Stapedectomy. 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 “Stapedectomy”?
Stapedectomy is a surgical procedure in which the innermost bone (stapes) of the three bones (the stapes, the incus, and the malleus) of the middle ear is removed, and replaced with a small plastic tube of stainless-steel wire (a prosthesis) to improve the movement of sound to the inner ear.
Why is it done?
A stapedectomy is used to treat progressive hearing loss caused by otosclerosis, a condition in which spongy bone hardens around the base of the stapes. This condition fixes the stapes to the opening of the inner ear, so that the stapes no longer vibrates properly; therefore, the transmission of sound to the inner ear is disrupted. Untreated otosclerosis eventually results in total deafness, usually in both ears.
How does one prepare for surgery?
Prior to admission to the hospital, the patient will be given a hearing test to measure the degree of deafness, and a full ear, nose, and throat exam.
What happens during the surgery?
With the patient under local or general anesthesia, the surgeon opens the ear canal and folds the eardrum forward. Using an operating microscope, the surgeon is able to see the structures in detail, and evaluates the bones of hearing (ossicles) to confirm the diagnosis of otosclerosis.
Next, the surgeon separates the stapes from the incus; freed from the stapes, the incus and malleus bones can now move when pressed. A laser (or other tiny instrument) vaporizes the tendon and arch of the stapes bone, which is then removed from the middle ear.
The surgeon then opens the window that joins the middle ear to the inner ear and acts as the platform for the stapes bone. The surgeon directs the laser's beam at the window to make a tiny opening, and gently clips the prosthesis to the incus bone. A piece of tissue is taken from a small incision behind the ear lobe and used to help seal the hole in the window and around the prosthesis. The eardrum is then gently replaced and repaired, and held there by absorbable packing ointment or a gelatin sponge. The procedure usually takes about an hour and a half.
Who are the good candidates for the surgery?
Good candidates for the surgery are those who have a fixed stapes from otosclerosis, and a conductive hearing loss at least 20 dB. Patients with a severe hearing loss might still benefit from a stapedectomy, if only to improve their hearing to the point where a hearing aid can be of help. The procedure can improve hearing in more than 90% of cases.
Aftercare:
The patient is usually discharged the morning after surgery. Antibiotics are given up to five days after surgery to prevent infection; packing and sutures are removed about a week after surgery.
Precautions:
It is important that the patient not put pressure on the ear for a few days after surgery. Blowing one's nose, lifting heavy objects, swimming underwater, descending rapidly in high-rise elevators, or taking an airplane flight should be avoided.
Right after surgery, the ear is usually quite sensitive, so the patient should avoid loud noises until the ear retrains itself to hear sounds properly.
It is extremely important that the patient avoid getting the ear wet until it has completely healed. Water in the ear could cause an infection; most seriously, water could enter the middle ear and cause an infection within the inner ear, which could then lead to a complete hearing loss. When taking a shower, and washing the hair, the patient should plug the ear with a cotton ball or lamb's wool ball, soaked in Vaseline. The surgeon should give specific instructions about when and how this can be done.
When can the patient resume normal activities?
Usually, the patient may return to work and normal activities about a week after leaving the hospital, although if the patient's job involves heavy lifting, three weeks of home rest is recommend. Three days after surgery, the patient may fly in pressurized aircraft.
Normal results:
Most patients are slightly dizzy for the first day or two after surgery, and may have a slight headache. Hearing improves once the swelling subsides, the slight bleeding behind the ear drum dries up, and the packing is absorbed or removed, usually within two weeks. Hearing continues to get better over the next three months.
Prognosis:
About 90% of patients will have a completely successful surgery, with markedly improved hearing. In 8% of cases, hearing improves, but not quite as patients usually expect. About half the patients who had ringing in the ears (tinnitus) before surgery will have significant relief within six weeks after the procedure.
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) Total loss of hearing (complete and irreversible loss of hearing in the operated ear i.e. Dead ear). This is usually due to complications arising during the course of the operation but may also occur during the early or late post-op period despite the operation being uneventful.
(b) Partial loss of hearing where the hearing is worse after the operation. This is usually due to complications arising during the course of the operation but may also occur during the early or late post-op period despite the operation being uneventful.
(c) Failure to improve hearing, where there is no improvement in hearing after the operation. This may occur despite the operation being uneventful but may also be due to another disease process involving the bones in the middle ear.
(d) Altered sensation of taste. The nerve carrying taste fibers to the same side of the tongue may need to be divided (cut) or stretched to obtain access to the stapes bone resulting in an altered taste which may be temporary or permanent.
(e) Ringing in the ear (tinnitus). Otosclerosis is often associated with tinnitus. In some cases the tinnitus may be worse after surgery and may be temporary or permanent.
(f) Dizziness or imbalance may occur and may be temporary or permanent.
(g) Bleeding or infection in the ear or in the wound.
(h) Facial nerve palsy. Temporary or permanent paralysis of the muscles of the face may rarely occur.
(i) Perforation of the tympanic membrane (ear drum) may rarely occur and may require further surgery to repair the perforation.
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: STAPEDECTOMY


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- "Stapedectomy” 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) Total loss of hearing (complete and irreversible loss of hearing in the operated ear i.e. Dead ear). This is usually due to complications arising during the course of the operation but may also occur during the early or late post-op period despite the operation being uneventful.
(b) Partial loss of hearing where the hearing is worse after the operation. This is usually due to complications arising during the course of the operation but may also occur during the early or late post-op period despite the operation being uneventful.
(c) Failure to improve hearing, where there is no improvement in hearing after the operation. This may occur despite the operation being uneventful but may also be due to another disease process involving the bones in the middle ear.
(d) Altered sensation of taste. The nerve carrying taste fibers to the same side of the tongue may need to be divided (cut) or stretched to obtain access to the stapes bone resulting in an altered taste which may be temporary or permanent.
(e) Ringing in the ear (tinnitus). Otosclerosis is often associated with tinnitus. In some cases the tinnitus may be worse after surgery and may be temporary or permanent.
(f) Dizziness or imbalance may occur and may be temporary or permanent.
(g) Bleeding or infection in the ear or in the wound.
(h) Facial nerve palsy. Temporary or permanent paralysis of the muscles of the face may rarely occur.
(i) Perforation of the tympanic membrane (ear drum) may rarely occur and may require further surgery to repair the perforation.

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……………………………………

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