Informed Consent, Disclosure and Patient Agreement Forms

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Informed Consent, Disclosure and Patient Agreement Forms
PATIENT: __________________________________
HOSPITAL : University of Mississippi Medical Center
DATE:_______________________
I, ________________, have been unsuccessful in losing weight by dietary means and request my
surgeon to perform the Adjustable Gastric Banding procedure on me for the treatment of my
morbid obesity. The surgeon has explained the Adjustable Gastric Banding procedure to me
along with the alternative procedures, and potential complications.
I realize that risks are common to all surgical procedures and I thoroughly realize that due to my
severe obesity and/or co-morbid conditions, I am at an increased risk over your average patient
for surgical complications. Regardless of the statement above, I voluntarily wish to proceed
with my weight loss operation.
________________
__________________
Patient’s Initials
Surgeon’s Initials
ALL PRESENT
_________________________________ (RELATIONSHIP) ________________________
_________________________________
________________________
Informed Consent and Disclosure Form Page 2
PATIENT: «PATIENT»
Laparoscopy surgery is a technique used by surgeons to perform the operation without the need
for major open surgery requiring a large incision. The laparoscope is a tubular instrument
similar to a telescope that can be placed inside the abdomen. It is usually placed near the belly
button after a small (1/2”-3/4”) skin incision is made. After the laparoscope is within your belly,
the doctors are able to see your organs and other structures. Additional instruments are needed
to do your surgery, so there will be 3-6 additional small tubes that will be put through small ¼” –
½” skin incisions.
Occasionally, your surgeon may determine that it is unsafe to continue the surgery through
laparoscopy and elect to open your abdomen after the laparoscopic surgery has started. The
usual reasons for such a conversion may be an inability to clearly see the surgery area, correct
bleeding or injury of surrounding structures. I agree to an open operation should the surgeon
deem it necessary, and I agree to any emergency surgery that might arise during this procedure.
________________
Patient’s Initials
__________________
Surgeon’s Initials
I understand that while it is not normally done, it may be necessary to remove the gall bladder,
possibly perform hiatal hernia repair, and possibly perform liver biopsy. A hiatal hernia occurs
when the normal opening in the diaphragm is too large. If the problem is not repaired, the
stomach or other abdominal contents may bulge (herniate) into the chest, causing heartburn (acid
reflux) and serious damage to the esophagus. It will also make the Band difficult to adjust if not
repaired. My surgeon has informed me that there may be additional risks if any of the above
additional procedures are performed and I authorize my physicians to perform such other
procedures which are advisable in their professional judgment.
________________
__________________
Patient’s Initials
Surgeon’s Initials
Pictures or video may be taken during laparoscopic surgery and used to: (1.) Show you what has
been done. (2.) Be a permanent part of your medical record. (3.) Be used for teaching other
patients and other surgeons about these procedures. (If used, your face will not be shown and you
will not be identified). I give permission for video and photographs to be taken during surgery to
be used as described above.
Your primary surgeon, «Surgeon», will determine the need for an assisting surgeon. Your
facility will be University of Mississippi Medical Center.
I voluntarily permit «Surgeon», my physician(s), and such associates, technical assistants and
other health care providers as may be deemed necessary to treat my condition which has been
explained to me by my physician as: MORBID OBESITY.
Informed consent and Disclosure page 3
PATIENT: «PATIENT»
I understand that my physician might discover other or different conditions which might require
additional or different procedures than those planned. I do authorize my physician and such
associates, technical assistants and other health care providers to perform such other procedures
which are advisable in their professional judgment.
I understand that no warranty or guarantee has been made to me regarding this procedure
since some patients may not benefit. Just as there may be risks and hazards associated with my
present condition, if untreated, there is no guarantee that complications related to the
performance of the surgical procedure might not occur. I understand that I may be at greater risk
due to my current medical condition. I have the following medical conditions:
________________________________________________________________________
________________________________________________________________________
A. SOME POSSIBLE COMPLICATIONS DURING SURGERY:
1. Injuries to abdominal organs and/or perforations (an opening of a hole into the stomach or
intestine), injury to the liver or pancreas, or leakage from the gallbladder duct. Injury to
the spleen. Such an injury could require increased surgery time to repair and/or perform
splenectomy (removal of spleen)
2. Injury to the diaphragm (muscles that help you breathe)
3. Injuries to arteries or veins which may result in excessive bleeding which could require a
blood transfusion
4. Arrhythmia (irregular heart beat) which may result in the heart not beating or pumping
properly or heart attack
5. Death
________________
__________________
Patient’s Initials
Surgeon’s Initials
B. SOME POSSIBLE COMPLICATIONS AFTER SURGERY:
1. Blood clots in the leg, pelvis or elsewhere, which can cause circulatory problems in the
legs or pulmonary embolism (blood clots migrating into the heart and lungs can
sometimes be fatal)
2. Gastric outlet stenosis/obstruction which may result in blockage preventing food from the stomach to enter the intestine. (Could require an outpatient
dilation procedure)
3. Small bowel obstruction that may result in blockage of the intestines. May require
operation to correct
4. Band slippage or stomach slippage, or band leak (fluid leaks out of band)
5. Leaks in tubing (requires additional surgery to replace)
6. Band can erode into the stomach.
7. Distention of the stomach requiring deflation of the band or possible surgical removal of
the device
8. Acute cholecystitis (inflammation and/or infection of gallbladder)
9. An abscess (a collection of pus) within the abdomen
10. Pneumonia (infection of the lung)
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Informed consent and Disclosure page 4
PATIENT: «PATIENT»
11.
12.
13.
14.
Phlebitis (inflammation of veins)
Wound dehiscence (opening up of the surgical wound)
Collection of blood, fluid or pus in the surgical wound
Bleeding from any part of the surgery – could require operation and possible blood
transfusion
15. Obstruction (food particles causing blockage of stomach)
16. Psychological changes/depression
17. Dysrhythmia (irregular heartbeats/ which may result in the heart not beating or pumping
properly or heart attack)
18. Death
C.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
________________
__________________
Patient’s Initials
Surgeon’s Initials
COMPLICATIONS WHICH MAY OCCUR MONTHS AFTER
YOUR SURGERY:
Ulcer formation in stomach or intestine
Hernia in the incision that may require surgical repair
Cholelithiasis (gall stones in the gallbladder which may result in removal of the
gallbladder)
Vomiting
Anorexia (lack or loss of appetite)
Hypoglycemia (low sugar levels in blood).
Partial hair loss (which is usually temporary)
Band slippage (gastric herniation) and band migration that may require the band to be
removed
Lap-Band port problems that may require operation
Psychological changes, including possible effects from new, smaller body image,
affecting interaction with friends and family
Permanent alteration of dietary and bowel habits
Kidney Failure
Death
________________
__________________
Patient’s Initials
Surgeon’s Initials
I have received weight loss surgery educational information and have participated in the presurgery educational process explaining my condition, the surgery, and the diet after surgery and
my need to participate in on-going support groups after surgery.
After review of the written information provided to me, the discussions with the staff and
discussions with my physician including the opportunity to ask any questions, I fully
understand that any of the complications listed above (but not limited to) could potentially
occur and could result in a need for re-operation (s), disability, or death. Furthermore, by
initialing after each complication section, I agree that each complication has been explained
to my complete understanding and satisfaction. The physician initials after my initials
indicate that the physician was present and available to answer any further questions at the
time of the completion of this form. I believe that I have sufficient information to give this
informed consent and that a copy of this form has been made available to me
. - continued on next page -
Informed consent and Disclosure page 5
PATIENT: «PATIENT»
I have read and understand this Informed Consent and sign it at my own free will without any
coercion. I have read the preceding 4 pages and have discussed this operation and alternate
treatment with «Surgeon». They have given me ample opportunity to ask questions on specific
points, and the surgeon has answered those questions to my satisfaction. I agree to an open
operation should the surgeon deem it necessary, and I agree to any emergency surgery that might
arise during this procedure.
DATE: _____________________
TIME: _________________________A.M. / P.M.
(Minor Patient and Parent/Guardian both sign)
_____________________________
Signature of Patient
___________________________________
Signature of Witness
_____________________________
Signature of Parent or Legal Guardian
«Surgeon»,
MD
Name of Physician Obtaining Consent
___________________________________
Signature of Physician Obtaining Consent
Informed Consent, Disclosure and Patient Agreement Forms
Bariatric Surgery Contract
I, _________________, have voluntarily asked Dr. ___________and the treatment
team at The University of Mississippi Medical Center to perform an Adjustable
Gastric Band on me to lose weight. I understand that this surgery requires lifelong
commitment and major necessary adjustments in my lifestyle and eating habits. I
understand that following the surgery, I may not be able to eat certain foods, which
I can eat now, and vomiting may occur from time to time, especially if I am not
careful about what and how I eat.
I hereby promise to follow the following guidelines:
1. I will follow the prescribed diet to include purchasing and consuming protein supplements.
____Initials
2. I will purchase and take the prescribed vitamin and mineral supplements for life.
____Initials
3. I am now aware that behavior modification is an important educational process, which will be
made easier as a result of my surgery. I understand that such change involves; exercise, changes
in the type and amount of food I eat, liquids I drink, number of meals I eat per day, and how
thoroughly I chew and how fast I eat.
_____Initials
4. I realize my liver may be sensitive after this surgery and I should stay away from alcohol and
any drugs that may cause liver damage.
_____Initials
5. I will make and keep my follow-up appointments as required.
_____Initials
6. I will schedule and obtain my blood work as prescribed by my physician.
_____Initials
7. I will report problems to my physician or treatment team.
_____Initials
8. FEMALES: I understand that I should not become pregnant within 18 months after
LapBand. Further I realize that becoming pregnant during this period after surgery could
cause serious harm to my health. I pledge that I will take the proper precautions to prevent
becoming pregnant (at least two forms of birth control). I also pledge to seek the advice of a
physician should I have any questions as to the proper precautions in prevention of
pregnancy. After the initial post-operative period I will seek the advice of a physician prior
to stopping preventive measures and possibly become pregnant.
______Initials
9. I will follow and frequently re-read bariatric surgery information and my patient education
manual.
______Initials
10. I will attend surgical weight loss support groups.
______Initials
11. I understand that chronic vomiting or chronic overeating may cause the band to slip which
would require an operation to repair. This may not be covered by insurance.
______Initials
12. I want to have this surgery because of the following:
___ I want to live a long life
___ I want to be able to walk up a flight of stairs and other physical activities
___ I want to improve my self-esteem
___ my weight causes me to be depressed
___ I want to socialize outside of my home & not worry about booth size, armless chairs, etc.
___ I’m tired of being discriminated against because of my size
___ I want to be more productive at work
___ I want to be able to play with my children/grandkids
According to the National Institute of Health, I am __________ lbs overweight, with a
BMI____. My target/goal is to lose
of those lbs.
I agree to follow all instructions and keep my surgeon informed of my progress regarding my
medical problems as well as any change in my address or phone number at all times. I have read
and understand this Agreement and sign it at my own free will without any coercion.
Patient Signature_________________________________ Date:_________________________
Witness ________________________________________ Date: _________________________
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