Current through Register Vol. 49, No. 2, February 2024
Pursuant to Act 1356 of the 84th General Assembly of 2003, all
physicians in this state, prior to performing gastric bypass surgery, also
known as open or laproscopic Roux En Y, will have the patient sign an informed
consent form acknowledging that they have been told information about and
various complications that can result from the surgery. The complications and
information the patient must be informed of are as follows:
A. The potential risks, complications and
benefits of the weight loss surgery.
B. The alternatives to surgery including
non-surgical options.
C. The need
for dietary changes, a development of an exercise plan and the possible need
for counseling.
D. The importance
of proper nutrition, eating a balanced diet and taking vitamin and mineral
supplements for the remainder of their life.
E. There is no guarantee of weight loss and
the need for long term weight management as a result of getting the
surgery.
F. A life time of
follow-up medical care is required.
G. Lab work will be required annually or more
often than that as directed by the physician.
H. Potentially serious complications from the
surgery could result in death, further surgery, or prolonged hospital stays for
the patient.
I. The following
surgical complications may arise:
(1)
Bleeding, this may require a transfusion of blood or blood products
(2) Surgical site infections, either
superficial or deep to include port sites for laproscopic access. These could
lead to wound breakdowns and hernia formation.
(3) Perforations (leaks) of the stomach or
intestine causing peritonitis, subphrenic abscess or enteroenteric or
enterocutaneous fistulas.
(4)
sepsis
(5) Systemic Inflammatory
Response Syndrome (SIRS)
(6) Adult
Respiratory Distress Syndrome (ARDS)
(7) Myocardial infarction (heart
attack)
(8) Cardiac rhythm
disturbances
(9) Congestive heart
failure
(10) Atelectasis
(11) Pneumonia
(12) Pulmonary edema (fluid in the
lungs)
(13) Pleural effusions
(fluid around the lungs)
(14)
Injury to adjacent structures, including the spleen, liver, diaphragm, pancreas
and colon.
(15) Possible removal of
the spleen
(16) Stroke
(17) Kidney failure
(18) Pressure sores
(19) deep vein thrombosis (blood clots in the
legs or arms)
(20) pulmonary
embolism (clots migrating to the heart and lungs)
(21) staple line disruption
(22) Ulcer formation (marginal ulcer or in
the distal stomach)
(23) Small
bowel obstructions
(24) Internal
hernias
(25) Incisional hernias,
this includes port sites for laproscopic access
(26) Dehiscence or evisceration
(27) Inadequate or excessive weight
loss
(28) Kidney stones
(29) Gout
(30) Encephalopathy
(31) Stoma Stenosis
(32) Urinary tract infections
(33) Esophageal, pouch, or small bowel
motility disorders
J.
Nutritional Complications to include:
(1)
Protein malnutrition
(2) Vitamin
deficiencies, including B12, B1, B6, Folate and fat soluble vitamins A, D., E,
and K
(3) Mineral deficiencies
including calcium, magnesium, iron, zinc and copper and other trace
minerals.
(4) Uncorrected
deficiencies can lead to anemia, neuro-psychiatric disorders and nerve
damage
K. Psychiatric
complications to include:
(1)
Depression
(2) Bulimia
(3) Anorexia
(4) Dysfunctional social problem
L. Other Complications to include:
(1) Adverse outcomes may be precipitated by
smoking
(2) Constipation
(3) Diarrhea
(4) bloating
(5) cramping
(6) development of gallstones
(7) Intolerance of refined or simple sugars,
dumping, with nausea, sweating and weakness
(8) low blood sugar, especially with improper
eating habits
(9) vomiting, the
inability to eat certain foods, especially with improper eating habits or poor
dentition.
(10) loose
skin
(11) intertriginous dermatitis
due to loose skin
(12) malodorous
gas, especially with improper food habits
(13) hair loss (alopecia)
(14) anemia
(15) bone disease
(16) stretching of the pouch or the
stoma
(17) low blood
pressure
(18) cold
intolerance
(19) fatty liver
disease or non alcoholic liver disease (NALF)
(20) Progression of existing of preexisting
NALF or cirrhosis
(21) vitamin
deficiencies may already exist before surgery
(22) diminished alcohol tolerance
M. Pregnancy complications should
be explained as follows:
(1) Pregnancy should
be deferred for 12-18 months after surgery, or until after the weight loss is
stabilized
(2) Vitamin
supplementation during the pregnancy should be continued
(3) Extra folic acid should be taken if the
pregnancy is planned.
(4) Obese
mothers have a children with a higher incidence of neural tube defects and
congenital heart defects.
(5)
Pregnancy should be discussed with the obstetrician.
(6) Special nutritional needs may be
indicated or necessary.
(7) Secure
forms of birth control should be used in the first year after
surgery.
(8) Fertility improves
with weight loss
Some or all of the complications listed in this regulation may
exist in a patient whether the surgical procedure of gastric bypass is
performed on the patient or not. This regulation is not meant to imply that in
all cases gastric bypass surgery is the only cause of these
complications.
A failure of a physician to inform a patient prior to gastric
bypass surgery of the above complications and obtaining the patient's signature
on a form acknowledging the same will be a violation of the Medical Practices
Act and may result in disciplinary proceedings before the Board pursuant to
law.