INFORMED CONSENT - University of Mississippi Medical Center

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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 Laparoscopic Roux-en-Y Gastric Bypass on me for the treatment of
my morbid obesity. Dr. __________________has explained the Laparoscopic Roux-en-Y
Gastric Bypass procedure to me along with the alternatives 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 the 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) ________________________
_________________________________
________________________
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Informed Consent and Disclosure Form Page 2
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. During the Laparoscopic Roux-en-Y Gastric Bypass procedure, stapling
creates a small (15 to 30cc) stomach pouch. The remainder of the stomach is not removed, but is
completely stapled shut and divided from the stomach pouch. The outlet from this newly formed
pouch empties directly into the lower portion of the jejunum, which is done by dividing the small
intestine just beyond the duodenum. The other end is connected into the side of the Roux limb
of the intestine creating the “Y” shape that gives the technique its name.
You have been informed that laparoscopic surgery may increase operating time and the time that
you are asleep (prolonged anesthesia). 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, or to 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 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. 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.
________________
__________________
Patient’s Initials
Surgeon’s Initials
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Informed Consent and Disclosure Form Page 3
PATIENT: ______________________________________
Your primary surgeon will determine the need for an assisting surgeon.
I voluntarily permit my 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.
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 also realize that in addition, 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, pancreas or 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. Leaks involving the stomach or intestines leading to peritonitis (infection) and probable
reoperation
4. Small bowel obstruction that may result in blockage of the intestines. May require
reoperation to correct
5. Distention or edema of the stomach pouch
6. An abscess (a collection of pus) within the abdomen.
7. Pneumonia (infection of the lung).
8. Phlebitis (inflammation of veins).
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Informed Consent and Disclosure Form Page 4
PATIENT: ______________________________________
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
Wound dehiscence (opening up of the surgical wound).
Distention or edema of the stomach pouch
An abscess (a collection of pus) within the abdomen.
Pneumonia (infection of the lung).
Phlebitis (inflammation of veins).
Wound dehiscence (opening up of the surgical wound).
Breakdown of the staple line
Collection of blood, fluid or pus in the surgical wound.
Bleeding from any part of the surgery – could require operation and possible blood
transfusion.
Bezoar obstruction (food particles causing blockage of stomach).
Psychological changes/depression.
Dysrhythmia (irregular heart beats/which may result in the heart not beating or pumping
properly or heart attack).
Death.
________________
__________________
Patient’s Initials
Surgeon’s Initials
C. COMPLICATIONS WHICH MAY OCCUR MONTHS AFTER YOUR SURGERY:
1. Gastroplasty stoma obstruction (blockage of the outlet of the stomach, usually due to
food)
2. Gastroplasty stoma stenosis (narrowing of the outlet of the stomach which may result in
an inability to eat properly and/or vomiting)
3. Gastroplasty stoma enlarging or swelling
4. Gastroplasty pouch enlarging or swelling
5. Ulcer formation in stomach or intestine
6. Small bowel obstruction (blockage) that may require operation to correct
7. Hernia in the incision that may require surgical repair
8. Cholelithiasis (gallstones in the gallbladder which may result in surgical removal of the
gallbladder )
9. Diarrhea and or foul flatulence
10. Dumping syndrome that may result in dizziness, nausea and diarrhea
11. Permanent alteration of dietary and bowel habits.
12. Difficulty in examining the lower part of the stomach after gastric bypass surgery
13. Vomiting
14. Anorexia (lack or loss of appetite)
15. Hypoglycemia (low sugar levels in blood)
16. Protein malnutrition, vitamin, and trace mineral deficiencies, partial hair loss (which is
usually temporary), brittle nails and skin rashes
17. Peripheral and central neuropathy ( nerve tissue malfunction)
18. Psychological changes, including possible effects from new, smaller body image,
affecting interaction with friends and family.
19. Liver failure
20. Death
______________
Patient’s Initials
__________________
Surgeon’s Initials
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Informed Consent and Disclosure Form Page 5
PATIENT: _____________________________________________
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 reoperation (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.
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 Dr._____________________________. 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.
_____________________________
Signature of Patient
___________________________________
Signature of Witness
_____________________________
Signature of Parent or Legal Guardian
__________________________, MD
Signature of Physician Obtaining Consent
PHYSICIAN'S SIGNATURE________________________________
Informed Consent, Disclosure and Patient Agreement Forms
Bariatric Surgery Contract
Roux-en-Y Gastric Bypass
I, __________________have voluntarily asked Dr.________________ and the treatment team at
University of Mississippi Medical Center to perform a Roux-en-Y Gastric Bypass 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, if this operation is done on me, I agree to do my part and 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. (With
special emphasis on Vitamin B-12, Iron and Calcium)
____Initials
3. I am now aware that behavior modification is an important on-going 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 will not smoke or use nicotine products after my operation.
_____Initials
5. 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
6. I will make and keep my follow-up appointments as required.
_____Initials
7. I will schedule and obtain my blood work as prescribed by my physician.
_____Initials
8. I will report problems to my physician or treatment team.
9. I understand that the use of some medications, such as long term use of NSAIDS may lead to
pouch ulceration. I will notify my surgeon, bariatric team, and/or primary care physician of any
mediations that I am prescribed.
_____Initials
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9. FEMALES: I understand that I should not become pregnant within 24 months after bariatric
surgery. 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
10. I will follow and frequently reread bariatric surgery information and my patient education
manual
_____Initials
11. I will attend surgical weight loss support groups
_____Initials
12. I want to have this surgery because of the following:
 ___I want to be able to play with my children/grandkids
 ___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 and 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
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: _________________________
Gastric Bypass contract
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