U.S. Department of Health and Human Services
Advisory Committee on Organ Transplantation
Recommendations to the Secretary
LIVING LIVER DONOR INFORMED CONSENT FOR EVALUATION
I am being given
the choice to undergo surgery to remove a part of my liver, which
will be transplanted into a potential recipient.
In order for
me to make this decision, I must understand enough about its risks
and benefits to make an informed decision. This process is known
as informed consent. This consent form provides information about
the surgery that will be discussed with me. Once all my questions
have been answered, I will sign this form showing that I am, of
my own free will, choosing to donate a part of my liver.
I understand
that I cannot receive any payment or anything of value if I agree
to be a donor.
I am free to
ask any questions and I am free to change my mind and remove my
consent at any time.
SURGERY
Interrupted
Surgery
The evaluation
process of the potential donor and recipient does not stop when
the surgery begins. It continues throughout the surgery. If at any
point the surgical team believes that I am at risk or that the segment
of my liver is not right for transplant, the surgery will be stopped.
This happens in the United States at least 5% of the time.
Risks
The surgery
that I will have is called a partial hepatectomy (the surgical removal
of a part of my liver). This surgery is most commonly used to treat
liver diseases. Partial hepatectomy can be done safely. But with
any major surgery, there are risks involved, even the risk of death.
Partial hepatectomy in a well person carries less risk than when
it is done to treat someone who is sick with liver disease.
My gallbladder
will be removed during this surgery. The gallbladder is not needed
for my normal function. Some people who have their gallbladder removed
have periods of diarrhea and cramping, which may last for two-three
months.
There are always
risks with any surgery, but a surgery that will remove between 25-60%
of the liver carries more than the average risk. Pain, bleeding,
infection and/or injury to other areas in the abdomen, as well as
death, are potential risks. Other risks include postoperative fevers,
pneumonia, and urinary tract infection.
Patients who
have abdominal surgery are also at risk to form blood clots in their
legs. These blood clots can break free and move through the heart
to the lungs. In the lungs, the blood clot may cause a serious problem
called pulmonary embolism. Pulmonary embolism is usually treated
with a blood thinner. In some cases, these clots can cause death.
There are special devices used to keep blood flowing in the legs
during surgery to try to prevent the blood clots from forming.
There are also
risks that are specific only to liver surgery. During the pre-surgery
evaluation, the transplant team tries to find out what your liver
looks like so that they can decide what piece can safely be taken
out. For the living liver donation, 25-60% of the liver will be
removed. Removal of a portion of the liver may cause the remaining
liver to not work as well for a short period of time. The part of
the liver left behind will begin to grow back within a few weeks
and get better. But, a person who has a piece of his/her liver removed
can develop liver failure. In some cases, this liver failure may
require a liver transplant to treat. This is a very rare event,
about 2 transplants per 1000 living liver donor surgeries. At ____________,
this has occurred _________.
The most common
liver related problem (complication) is a bile leak. The reported
rate of this happening ranges from 5-15%. At this center, this occurs
about ______of the time. Most bile leaks get better without having
to have another surgery. A leak may need for you to have tubes placed
that pass through the skin and into the liver to drain bile from
the liver into a bag worn outside the body for a period of time.
This often can be done without having surgery.
Biliary strictures
(narrowing of the large ducts that drain the liver) can also occur
after this surgery. Since this will be a long-term problem and living
liver donor transplants are so new, there is not enough data to
know how often this will occur. Early data shows that this problem
should be rare. Some of them can be fixed without surgery.
Another rare
event that may happen is injury to the spleen during the surgery.
If this occurs, the spleen will be removed. The spleen helps to
prevent bacterial infections, most commonly pneumonia. Getting a
vaccination can usually prevent these infections. These infections
can also be treated with antibiotics. If the infections are not
treated, they can cause death.
Across the country,
the risk of having some type of problem, minor or major, from this
surgery is 15-30% (about 2 in 7 cases). At this center, _____% of
donors have had problems after surgery. Most problems are minor
and get better on their own. Rarely do they require another surgery
or procedure. Living liver donor transplants are still very new
so there may be risks that are not yet known.
So far in the
United States, the mortality rate (death) has been about 0.2% or
2 deaths in about 1000 donors. ________number of donor deaths have
occurred in this center.
General
Anesthesia
This surgery
will be done under general anesthesia. There are a number of known
possible risks with any surgery done under general anesthesia. An
anesthesiologist will explain these to me and I will need to sign
a separate consent for anesthesia.
Blood
Transfusions
I may need blood
transfusions during this surgery, although transfusions are usually
not necessary during the surgery. It may be possible to bank my
own blood before the surgery. I may need more blood than I have
banked. During this surgery and after care, I clearly consent to
the use of stored blood or blood products if it is needed. I have
been fully informed of the associated risks with the use of blood
or blood products. Although the blood is carefully checked for HIV,
Hepatitis and other diseases, there is still a very small risk that
I will be infected.
Post-Surgical
Course/Discomforts
I further agree
that after my surgery, drains will be placed in my body to help
me heal. I will go to a unit (hospital floor) where I will be closely
watched. There is a chance that I could be placed on a machine to
help me breath after surgery. I will feel pain (for example: gas
pains, sore throat, soreness, backaches, etc.) after the surgery.
I also understand that I may become confused for a short time because
of medications. At some point I will be moved to a less acute floor.
I will remain
in the hospital as long as needed, depending on how fast I get better.
Usually, donors are discharged 7 days after surgery. For the most
part, donors are usually pain-free three weeks after the surgery;
some people continue to have pain for a longer period but this unusual.
The recovery period at home is 4-6 weeks. Should I have any problems,
the recovery period may be longer. Most donors return to their usual
activities in ____ weeks. They usually return to their most demanding
activities in ___ months.
I understand
and agree that a team of doctors at the __________________________
will follow me. I will be given appointments to see my doctors and
have blood work and possible scans of the abdomen to see how my
liver is doing.
Insurance/Pre-existing
Conditions
I understand
and agree that, after the living liver donor surgery, my health
insurance company may identify me as having a pre-existing liver
disease and/or abdominal related problems. Future liver disease
or abdominal related problems may not be covered by my insurance
because I have been a living liver donor. If these problems are
not related to the surgery and are not covered by my insurance company,
I will be responsible for all costs.
I understand
and agree that my insurance may be billed by this hospital for denial
of claims before the recipient's insurance can be billed. I understand
and agree that both future health, disability, and life insurance
premiums may be higher due to this donation. I understand and agree
that I also may not be able to get health, disability, and life
insurance in the future if I lose my current insurance or if I am
not now insured.
Recipient
Organ Failure
It is possible
that the donor segment of my liver may not work or may be rejected
by the recipient's immune system. This may require that he or she
be placed on the Organ Procurement and Transplantation Network (OPTN)
list to wait for another liver. During the waiting time, death may
occur.
ALTERNATIVES
The alternative
to living liver donation is cadaveric liver donation, using a liver
from a donor who is declared brain dead. Should I decide not to
donate a portion of my liver, the potential recipient will continue
to receive care by the liver transplant team at ______________________________.
His or her name will remain on the Organ Procurement and Transplantation
Network (OPTN) liver transplant waitlist and he or she will wait
for a cadaveric donor organ or another living liver donor to become
available. The details of this process will be described to me.
RECIPIENT BENEFITS
I understand
that, by my donation, the recipient will receive a benefit. For
the most part, this benefit includes a decrease in waiting time
on the list, which might have an effect on his/her recovery. Graft
failure in the recipient occurs 5-10% of the time and may lead to
a repeat transplant or death. This has happened in this center_________.
DONOR BENEFITS
I understand
that there is no medical benefit to me by having this surgery. A
possible medical benefit of the evaluation is finding out about
health problems that I did not know that I had so that I may seek
treatment.
CONFIDENTIALITY
Hospital personnel
who are involved in the course of my care may review my medical
record. They are required to maintain confidentiality as per law
and the policy of this hospital. If I do become a donor, data about
my case, which will include my identity, will be sent to the OPTN
and may be sent to other places involved in the transplant process
as permitted by law.
ADDITIONAL INFORMATION
I understand
that I may obtain more information about living liver donor transplants
from the www.unos.org web page.
__________________ transplant program will contact me from time
to time after the surgery to learn about any concerns I might have
about my health, insurance, employment and overall well being.
SIGNATURES
I, _________________________,
certify by my signature below that:
-
I have had
the surgery and the risks of the surgery explained to me by
my doctor, _____________________, and understand the risks involved
in the surgery.
-
I have read,
or had read to me, this informed consent form.
-
I have had
the chance to ask any questions I have about the surgery and
they have all been answered.
-
I understand
that I may withdraw my consent at any time prior to the surgery.
I, ______________________________________,
certify by my signature below that I would like to proceed with
the surgery:
______________________________________
Printed Name of Potential Donor
______________________________________
____________
Signature Date
______________________________________
Printed Name of Attending Physician
______________________________________
_____________
Signature of Attending Date
______________________________________
Printed Name of Witness
______________________________________
_____________
Signature Date
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