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 Laparoscopic Sleeve Gastrectomy on me for the treatment
of my morbid obesity. The surgeon has explained the Laparoscopic Sleeve Gastrectomy
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 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) ________________________
_________________________________
________________________
- continued on next page -
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.
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, correct bleeding or injury of surrounding structures.
I agree to an open operation should he 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 or gastric pouch. 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 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.
________________
Patient’s Initials
__________________
Surgeon’s Initials
Informed Consent and Disclosure Form Page 3
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 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. Severe nausea possibly requiring readmission for hydration.
2. 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.
3. Gastric stenosis/obstruction which may result in blockage- preventing food from the
stomach to enter the intestine (Could require an outpatient dilation procedure).
4. Leaks involving the stomach or leading to peritonitis (infection) and probable
operation.
5. Small bowel obstruction that may result in blockage of the intestines. May require
reoperation to correct.
6. Distention or edema of the stomach pouch.
7. An abscess (a collection of pus) within the abdomen.
8. Pneumonia (infection of the lung).
9. Phlebitis (inflammation of veins).
10. Wound dehiscence (opening up of the surgical wound).
11. Breakdown of the staple line.
12. Collection of blood, fluid or pus in the surgical wound.
Informed Consent and Disclosure Form Page 4
PATIENT
13. Bleeding from any part of the surgery – could require operation and possible blood
transfusion.
14. Psychological changes/depression.
15. Dysrhythmia (irregular heart beats/ which may result in the heart not beating or
pumping properly or heart attack).
16. Death.
________________
__________________
Patient’s Initials
Surgeon’s Initials
C. COMPLICATIONS WHICH MAY OCCUR MONTHS AFTER YOUR
SURGERY:
1. Gastric stenosis/obstruction which may result in blockage preventing food from the
stomach to enter the intestine (Could require an outpatient dilation procedure)
2. Gastroplasty pouch enlarging or swelling
3. Ulcer formation in stomach or intestine
4. Small bowel obstruction (blockage) that may require operation to correct
5. Hernia in the incision that may require surgical repair
6. Cholelithiasis (gallstones in the gallbladder which may result in surgical removal of
the gallbladder )
7. Diarrhea
8. Permanent alteration of dietary and bowel habits.
9. Vomiting
10. Stretching of stomach remnant causing weight regain
11. Anorexia (lack or loss of appetite)
12. Hypoglycemia (low sugar levels in blood)
13. Protein malnutrition, vitamin, and trace mineral deficiencies, partial hair loss (which
is usually temporary), brittle nails and skin rashes
14. Peripheral and central neuropathy ( nerve tissue malfunction)
15. Psychological changes, including possible effects from new, smaller body image,
affecting interaction with friends and family.
16. Liver failure
17. Death
______________
__________________
Patient’s Initials
Surgeon’s Initials
D. IMPLICATIONS WHICH MAY OCCUR MONTHS AFTER YOUR
SURGERY:
I understand that VSG is an irreversible operation. I understand the removed
portion of the stomach cannot be replaced. This process may render other
operations requiring a complete stomach (feeding gastrostomy, esophageal
replacement for cancer, etc.) impossible.
______________
__________________
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. I have been told
particularly with this procedure that there is a minimal amount of long term data and
outcome reported and I still wish to proceed with the sleeve 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.
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 my 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.
_____________________________
Signature of Patient
___________________________________
Signature of Witness
_____________________________
Signature of Parent or Legal Guardian
Dr.
_______________
Name of Physician Obtaining Consent
Informed Consent, Disclosure and Patient Agreement Forms
Bariatric Surgery Contract
Sleeve Gastrectomy
I, ________________________, have voluntarily asked Dr. ________________and the treatment
team at The University of Mississippi Medical Center to perform a Sleeve Gastrectomy 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 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 will not smoke or use other 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.
_____Initials
continued on next page
9. 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
10. Follow and frequently reread bariatric surgery information and your patient education
manual
_____Initials
11. 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: _________________________
Sleeve contract
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