CONSENT INFORMATION - PATIENT COPY TRANSSPHENOIDAL SURGERY

PLEASE READ THIS SHEET BEFORE YOU CONSENT TO YOUR SURGERY

This information sheet provides general information to a person having a Transsphenoidal Surgery. It does not provide advice to the individual. It is important that the content is discussed between you and your doctor who understands your level of fitness and your medical condition. What is a pituitary tumor? A pituitary tumor is an abnormal growth in the pituitary gland, the part of the brain that regulates the body's balance of hormones. What are the symptoms associated with pituitary tumors? Symptoms associated with pituitary tumors include:

Hair changes
o o o

Loss of body hair Coarse, thin head hair Thinning of eyebrows

Weakness Lethargy Temperature sensitivity

o o

Intolerance to cold Intolerance to heat

Constipation Nausea and vomiting Low blood pressure Problems with the sense of smell Changes in weight
o o

Headache Visual changes

o o

Double vision Drooping eyelids

Weight loss (unintentional) Weight gain (unintentional)

Personality changes
o o

Decreased sexual interest Irritability Symptoms only in women:

Seizures Nasal drainage Skin changes Facial changes

o

Cessation of menses Abnormal nipple discharge Excessive body hair

Moon face, puffy eyes

Symptoms only in men:

MSSH/Physician/ Consent Transsphenoidal Surgery/Ver.1/Oct.2007

o Enlarged jaw and facial bones Patients Initials ________ Page 1 of 10

Breast development Impotence

You may request your nurse to show you the post surgical patient care unit so that you will know your surroundings after surgery.

How are they treated? Will the surgery hurt? Pituitary tumors are usually not cancerous and therefore won't spread to other areas of the body. However, they is can cause serious problems by putting pressure on the brain. Surgical removal often necessary, particularly if the tumor is pressing on the optic nerves, which could cause blindness. Most of the time, pituitary tumors can be removed through a transsphenoidal procedure -- the surgeon accesses the tumor through your nose and sinuses. However, some tumors cannot be removed this way and will require transcranial (through the skull) removal. What are the alternatives to treatment besides surgery? Pituitary tumors are usually curable. Treatment is often surgery to remove the tumor. Other options include medicines and radiation. What happens before the surgery? You will have blood tests, an electrocardiogram (EKG), and a chest x-ray. The night before surgery, you will not be allowed to eat or drink. The morning of surgery, you will bathe with a special antibacterial soap.
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You will be placed under general anesthesia. This means that you will be given an anesthetic that will keep you asleep during the operation. Your head will be placed in a headrest to keep it still during surgery. How is this surgery performed? Most pituitary tumors can be removed

transsphenoidally. The approach is through the sphenoid sinus, one of the facial air spaces behind the nose. Rarely, a craniotomy is required, where the skull is opened to reach the tumor. There are three basic approaches to the sella, which is the bony cavity in the skull base where the pituitary gland is located. How is the tumor removed? The tumor is usually soft and can be removed with small surgical instruments called curettes. In order to remove a large tumor through a small hole, the tumor itself has to be cut into small pieces. As the surgeon cores out the center of the tumor, the peripheral margin of the tumor has to fall into an area that can be reached by the surgeon. Some tumors, which have grown beyond the area of the sella, cannot be completely removed. Tumors that grow sideways into the cavernous sinus (a
MSSH/Physician/ Consent Transsphenoidal Surgery/Ver.1/Oct.2007

collection of veins next to the sella) usually cannot be completely removed. This is because that area contains important nerves controlling muscles of the eye and the carotid artery, which supplies the brain. Tumors which have a large amount of supra-sellar extension (up into the brain) can be removed in one operation if they fall downward into the sella during the

The procedure itself usually takes about three hours. Patients go to the recovery room for two to three hours after the surgery and are then admitted to the hospital floor. There is no need to stay in an Intensive Care Unit. Most patients are discharged from the hospital in just one or two days. How will I feel after the surgery? You will have a sinus headache and nasal congestion. This will gradually improve over a few weeks. You can take decongestants which will help these symptoms. It is common to feel fatigued for two-three weeks after the surgery and this gradually improves. After the surgery contact your Doctor if: You develop a fever over 100F (37.8C). You become dizzy or faint. You have nausea and vomiting. You have headache You have watery discharge through nose You have sudden visual disturbance.

procedure. Sometimes the removal of large tumors has to be staged into two operations, to allow time for the uppermost portion of the tumor to fall into the sella where it can be reached on a subsequent operation. What happens after the procedure? Immediately after surgery, you will be taken to the recovery room. You will be monitored closely until you are ready to be taken to your patient care unit. You will stay on the unit for 2 to 5 days. The head of your bed will be slightly raised (30 degrees) to promote blood flow from your head and decrease the fluid pressure in your head. If you have a spinal drain in place, you will lie flat. After surgery, be careful about doing certain types of physical activities. It is especially important not to cough, blow or pick your nose, sneeze, bend over, or strain for at least 1 month after surgery. How long does the operation take?
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Expectations from the surgery: If the tumor can be surgically removed, the probable outcome is fair to good, depending upon whether the entire tumor was removed. Remember to be patient with yourself and to focus on positive thinking during recovery. You play a large part in helping to assure your well-being after surgery.
MSSH/Physician/ Consent Transsphenoidal Surgery/Ver.1/Oct.2007

General Risks of having an Operation: 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 may majority be of patients with have an

(3) There is a very small chance of damaging the carotid arteries which are located on either side of the pituitary. This is a potentially devastating complication which could lead to stroke or death. (4) There could also be post-operative bleeding into any residual tumor or into the sella, which could lead to worsening pressure on the optic nerves or chiasm and possible visual loss. This is also a very rare complication, but might require re-operation to remove the blood clot. (5) A spinal fluid leak sometimes occurs because pituitary tumors are separated from the spinal fluid which bathes the brain by a very thin membrane. In order to prevent a spinal fluid leak, the tumor bed is packed with a small piece of abdominal fat taken from a tiny incision made in the abdominal skin. Despite this, spinal fluid leaks occur with an incidence of about 1%. If this happens, there is a risk of infection, called meningitis. If a spinal fluid leak occurs it may require a second operation to patch the leak. 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.

uneventful surgery and recovery, few cases associated 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: (1) The most common risk is damage to the normal pituitary gland. For macro adenomas (>1cm) this happens between 5-10% of the time when the operation is performed by an expert pituitary surgeon. This means that new hormone replacement might be required after the surgery, possibly including thyroid hormone, cortisol, growth hormone, estrogen or testosterone. (2) Damage to the posterior or back portion, of the pituitary gland may produce a condition known as diabetes insipidus, which will lead to frequent urination and excessive thirst, since the kidneys will no longer adequately concentrate the urine. Permanent diabetes insipidus occurs 1-2% of the time after pituitary surgery.
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MSSH/Physician/ Consent Transsphenoidal Surgery/Ver.1/Oct.2007

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 REFERENCES

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MSSH/Physician/ Consent Transsphenoidal Surgery/Ver.1/Oct.2007

INFORMED CONSENT: TRANSSPHENOIDAL SURGERY

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 patients own words) and I have been advised to undergo the following treatment/ procedure........................................ . See patient information sheet- Transsphenoidal surgery 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. OPERATION: The tumor is usually soft and can be removed with small surgical instruments called curettes. In order to remove a large tumor through a small hole, the tumor itself has to be cut into small pieces. As the surgeon cores out the center of the tumor, the peripheral margin of the tumor has to fall into an area that can be reached by the surgeon D.RISKS OF THIS PROCEDURE While majority of patients have an uneventful surgery and recovery, few cases may be associated with complications. These are seen infrequently and not all the ones listed below are applicable to one

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MSSH/Physician/ Consent Transsphenoidal Surgery/Ver.1/Oct.2007

individual. However it is important that you are aware of the complications/risks that may arise out of this procedure which are as below: (1) The most common risk is damage to the normal pituitary gland . For macro adenomas (>1cm) this happens between 5-10% of the time when the operation is performed by an expert pituitary surgeon. This means that new hormone replacement might be required after the surgery, possibly including thyroid hormone, cortisol, growth hormone, estrogen or testosterone. (2) Damage to the posterior or back portion, of the pituitary gland may produce a condition known as diabetes insipidus, which will lead to frequent urination and excessive thirst, since the kidneys will no longer adequately concentrate the urine. Permanent diabetes insipidus occurs 1-2% of the time after pituitary surgery. (3) There is a very small chance of damaging the carotid arteries which are located on either side of the pituitary. This is a potentially devastating complication which could lead to stroke or death. (4) There could also be post-operative bleeding into any residual tumor or into the sella, which could lead to worsening pressure on the optic nerves or chiasm and possible visual loss. This is also a very rare complication, but might require re-operation to remove the blood clot. (5) A spinal fluid leak sometimes occurs because pituitary tumors are separated from the spinal fluid which bathes the brain by a very thin membrane. In order to prevent a spinal fluid leak, the tumor bed is packed with a small piece of abdominal fat taken from a tiny incision made in the abdominal skin. Despite this, spinal fluid leaks occur with an incidence of about 1%. If this happens, there is a risk of infection, called meningitis. If a spinal fluid leak occurs it may require a second operation to patch the leak. (6) Due to any of the above reasons or due to any unwarranted circumstances, the surgery may have to be converted into a transcranial approach. The chances of this event though very low have been explained to me. E.SIGNIFICANT RISKS AND RELEVANT TREATMENT OPTIONS The doctor has explained any significant risks and problems specific to me, and the likely outcomes if complications occur.

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MSSH/Physician/ Consent Transsphenoidal Surgery/Ver.1/Oct.2007

The doctor also has 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) F.PATIENT CONSENT I acknowledge that: The doctor has explained my medical condition and 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 also explained the risks of not having the procedure. I have been given the Anesthesia informed consent form. 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 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 a doctor other than the consultant surgeon may conduct the procedure I understand this could be a doctor undergoing further training. 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 explained to me that if immediate life-threatening events happen during the procedure, they will be treated accordingly. 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 hereby authorize Drand those he may designate as associates or assistants to perform upon me the following medical treatment, surgical operation and / or diagnostic / therapeutic procedure..
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I REQUEST TO HAVE THE PROCEDURE Name of Patient/Substitute Decision Maker Relationship . SignatureDate. Name of the Witness Relationship/Designation SignatureDate G.INTERPRETERS STATEMENT I have given a translation in Name of interpreter. SignatureDate H. DOCTORS 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 SignatureDate..
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MSSH/Physician/ Consent Transsphenoidal Surgery/Ver.1/Oct.2007