information patient gb.ps, page 26 @ Preflight ( Mise en page 1 )

CONTENTS
Y OUR COMPANIONS
PAGE 3
SUMMARY
PAGE 4
THE INTRA-GASTRIC BALLOON
PAGE 5 à 7
THE PROGRAMME
PAGE 8 - 9
RECOMMENDATIONS TO BE OBSERVED AFTER
2
INSERTION OF THE BALLOON
PAGE 10
PHYSICAL ACTIVITY
PAGE 11
RULES CONCERNING DIET
PAGE 12
OBESITY
PAGE 13
CURRENT CARE AND
TREATMENTS FOR OBESITY
PAGE 14 - 15
QUESTIONS / ANSWERS
PAGE 16 à 19
BODY MASS INDEX (BMI) TABLE
PAGE 20
WEIGHT MONITORING CURVE
PAGE 21
WAIST MEASUREMENT MONITORING CURVE
PAGE 22
DIGESTION
PAGE 23
EXCESSIVE WEIGHT WEBSITE LINKS
PAGE 24
NOTES
PAGE 25 à 27
YOUR COMPANIONS – THE MULTI-DISCIPLINARY TEAM
They are there to listen to you throughout the treatment
He will insert and
extract the balloon
He supports the
paent throughout
the treatment.
He will assess and treat
the dietary behavioural
disorder
He will advise you on a
formula adapted to your
situaon taking into
account your dietary
habits.
He will monitor all your
major body funcons
throughout the procedures of inserng and
extracng the balloon.
The nutrional and behavioural treatment
is the guarantee of weight loss.
3
YOUR COMPANIONS – THE MULTI-DISCIPLINARY TEAM
Principle:
The intra-gastric balloon works by filling the stomach.
This causes a feeling of saety and a reducon in dietary
intake. Treatment with the balloon is combined with
dietec and behavioural treatment.
Non-surgical:
Endoscopic procedure*.
Characteriscs: Non-sterile, single use, bio-compable, radio-opaque,
filled with water or air.
Indicaons:
Body Mass Index (BMI) > 30 kg/m2
Before bariatric surgery for the “Super Obese” (BMI > 50 kg/m2)
Expected weight loss: At 6 months in the order of 32% of the excess weight, which
corresponds to weight loss of about 14 to 18 kg. Currently no significant study on the
maintenance of weight loss over me.
Average duraon of the operaon:
Inseron: 20-35 minutes (under general anaesthec with or without intubaon).
Removal: 30-90 minutes (under general anaesthec with intubaon).
Average length of hospitalisaon:
Day surgery or short hospitalisaon for the inseron.
Day surgery for the removal.
Duraon of treatment: ≈ 6 months maximum
Mortality linked to the operaon: 0.06% to 0.1%
Main risks of complicaons:
➢ Moderate: Abdominal pain, nausea, frequent voming inially which, in rare cases,
could lead to hypokalaemia, dehydraon or premature removal of the balloon.
Spontaneous deflaon of the balloon, gastro-oesophageal reflux, gastric ulcer,
oesophagis.
➢ Severe: Gastric perforaon, migraon of the balloon with intesnal obstrucon,
oesophageal incarceraon or oesophageal rupture during removal, acute pancreas.
Failure:
About 30% of paents do not obtain significant weight loss (> 10% of body weight).
These failures may be linked to early removal of the balloon for physical or
psychological intolerance, to premature disappearance of the effect on saety or
adaptaon of the dietary intake.
Films of the inseron and removal of the balloon may be downloaded from the
website, www.endalis.com
*Endoscopy is a method of exploraon and medical imaging which makes it possible to see inside
cavies that are inaccessible to the eye.
4
The IGB “Intra-Gastric Balloon” enables you to benefit from
the advantages of a non-surgical approach without medicaon to lose weight.
The intra-gastric balloon is an effecve aid.
The intra-gastric balloon is a starter which gives you a
feeling of fullness in the stomach and then of saety.
Your movaon and the associated nutrional and behavioural treatment will
enable you to lose weight.
Experts are agreed that to be successful, a weight loss programme should not only
help you to slim, but also not to regain the weight subsequently.
The intra-gastric balloon programme will enable you to:
•
•
•
•
•
Experience a feeling of saety
Lose more weight than with other slimming
regimes
Benefit from the support of a team of medical
experts
Learn the principles of durable success,
benefit from the advantages of a non-surgical
approach without medicaon
5
Indicaons for the balloon and place in the therapeuc strategy
In adult paents with BMI > 40 or > 35 + comorbidies
➢ Before bariatric surgery, in subjects with a BMI > 50 kg/m2, benefit of weight loss
linked to the balloon to reduce the surgical and anaesthec risks
➢ In subjects presenng a contraindicaon to bariatric surgery; within the
framework of orthopaedic surgery, the impact of weight loss before surgery.
In adult paents with BMI between 25 and 35 kg/m2
Contraindicaons to the inseron of the balloon
The presence of one of the following condions contraindicates the inseron of a
balloon:
➢ History of gastric surgery
➢ Digesve pathology: large hiatus hernias (> 5 cm), acve gastroduodenal ulcers,
severe oesophagis of Grade III or IV (Savary-Miller classificaon) or Grade C or D
(Los Angeles classificaon), Crohn’s disease or any other digesve tract lesion
that might bleed, pyloric stenosis and anomalies in the structure of the digesve tract
Diseases risking the vital prognosis in the short and medium term
➢
➢ Serious cognive or mental disorders
Severe, non-stabilised dietary behavioural disorders
➢ Alcoholism or drug addicon
➢ Treatment with an-platelet drugs or non-steroidal
an-inflammatories
➢ In the absence of treatment with acid-blockers
➢ Ancoagulants
➢ Foreseeable inability of the paent to parcipate in a
prolonged medical follow-up
➢ Absence of idenfied prior medical care
6
➢ Pregnancy, desire for a pregnancy during treatment with the balloon,
➢
➢
breaseeding
Serious liver disease
Haemostasis disorder
Complicaons
Mortality (0.06% to 0.1%) is most oen linked to gastric perforaon.
Serious complicaons are rare:
➢ Gastric perforaon (0.1% to 0.2%)
➢ Migraon of the balloon leading to an intesnal obstrucon (0.2% to 0.8%)
Most oen complicaons are moderate:
➢ Abdominal pain, nausea, frequent voming in the early days which, in rare
cases, may lead to hypokalaemia, dehydraon (1.6 %) or removal of the balloon
(1.8% to 4.2%)
➢ Spontaneous deflaon of the balloon (2.5% to 33 %)
➢ Gastro-oesophageal reflux (0.5% to 1.8%)
➢ A gastric ulcer (0.4%)
➢ Oesophagis (0% to 18%)
Restricon of acvity
It is strictly forbidden for the paent to scuba
dive or to fly in an unpressurised aircra.
The pracce of combat and extreme sports is
not advised in any circumstances.
7
THE PROGRAMME
Before the procedure
3 weeks
➢ Global care
➢
➢
This must be carried out by a mul-disciplinary team liaising with
the aending physician/general praconer.
As a minimum this team includes:
❍ A gastroenterologist
❍ A doctor specialising in obesity (nutrionist,
endocrinologist or specialist in internal medicine)
❍ A diecian or an endocrinologist
❍ A psychiatrist or a psychologist
❍ An intensive care anaesthest
Informaon on the advantages and disadvantages of the
balloon, the obligaon to remove the balloon aer 6 months,
the necessity for mul-disciplinary care and a long-term
follow-up. Paents must be advised on contracepon
The decision to insert the balloon must be taken aer
discussion and consultaon with the mul-disciplinary team.
Performance of the procedure
10 to 20 minutes
The inseron of the balloon must be performed:
➢ Under general anaesthec with or without tracheal intubaon
➢
➢
➢
➢
8
Under endoscopic control
In the endoscopy theatre
With equipment for monitoring vital funcons and respirator
By professionals who have received specific training
Aer the procedure
6 months
➢ Advice on a progressive, appropriate return to normal eang
➢ Prescripon of acid-blockers for 6 months, an-emecs,
an-spasmodics and pain killers
➢ Blood ionogram and creanaemia (3rd day)
➢ Consultaon with a member of the mul-disciplinary team every
4 to 6 weeks
➢ Programme of therapeuc educaon put in place with the
➢
mul-disciplinary team before the procedure and connued
aer the procedure
Informaon on the alarm signals for complicaons, follow-up
methods, the dietec and behavioural treatment within the
framework of a programme of therapeuc educaon.
Removal of the intra-gastric balloon
Removal of the balloon at 6 months is essenal. It can be done
earlier if there is intolerance or complicaons.
Removal is a technically difficult procedure which must be performed:
➢ Under general anaesthec with tracheal intubaon
➢ Under endoscopic control using the kits supplied by the
manufacturers for first intenon surgery
➢ In the endoscopy theatre with equipment for monitoring vital
funcons and respirator
➢ By professionals who have received specific training in a referral
centre already pracsing this procedure.
10 to 20
minutes
Following the removal procedure:
➢ Endoscopic verificaon that there are no gastric or oesophageal
lesions
➢ Consultaon at about the 15th day by a member of the
mul-disciplinary team.
Further to this, the follow-up must be mul-disciplinary in accordance with
the methods defined in the recommendaons for the treatment of the
obese adult.
9
RECOMMENDATIONS TO BE OBSERVED AFTER
THE INSERTION OF THE BALLOON
➢ Eat slowly, in a calm atmosphere, and chew
the food.
➢ Split the dietary intake into small quanes
➢
➢
➢
➢
➢
➢
➢
➢
10
(use small plates)
➢ If you feel a reflux of acid liquid or bloang,
stop eang
➢ Split the food into three meals and three snacks
➢ Avoid nibbling.
Drink at least one and a half litres of water a day.
Do not eat and drink at the same me. A glass of water half an
hour before the meal and one to two glasses of water half an
hour aer the meal are useful with the aim of rehydraon and,
above all, to clean the balloon. This prevents foul-smelling burps
of the bad egg type which are linked to the stagnaon of food
around the balloon
Avoid very fizzy drinks. Very strong tea and
coffee are not recommended either.
Avoid smoking on an empty stomach.
Do not eat the evening meal too late.
Wait at least two hours before going to bed.
Pains are possible when lying down to sleep
and also when bending to the side.
Intensify physical acvity. Walk for at least
fieen minutes per day
PHYSICAL ACTIVITY
Starng a physical acvity again is very
important.
Contrary to accepted ideas sport does lile to make
you lose weight, but it does enable you to stabilise your
weight loss.
The first month: progressive restarng of physical acvity (walking).
Aer the first month: you can take up any sport again.
The simplest acvity is walking. Find me to walk each
day (get off public transport one or two stops before
your normal stop, park several miles from your place of work, take the stairs
when you only have to go up a few floors, etc.).
Restarng physical acvity must be very progressive.
The more weight you lose the easier it will seem, so take advantage of this
to increase the duraon of your physical acvity.
Recommendaon:
Buy a pedometer (a small
machine that counts steps
which can be fixed on a
belt) in a sports shop.
Try to take 10,000 to
12,000 steps a day.
11
DIETARY RULES
➢ Drink 1.5l of water/day.
➢ To preserve vitamins and minerals, cook using steam rather
than in water.
➢ You may use the list of equivalents and the calorie table
for foodstuffs to vary your diet. For vegetables, their
nutrional value remains the same whether they are raw
or cooked.
➢ Use spices, herbs and condiments which will enable you to
season your preparaons. You can use lemon juice, soy sauce, salt,
all the spices (cumin, pepper, curry powder, paprika, etc.), all the herbs
(tarragon, chives, parsley, etc.), onions, mustard, garlic, vinegar,
gherkins, capers, Tabasco sauce, and fat-free stock cubes.
➢ Do not miss a meal. Have 3 meals (breakfast, lunch and dinner)
and 1 snack in the aernoon.
➢ Avoid snacking between meals.
➢ Take part in a physical acvity regularly as this will help the
weight loss, e.g. walking, cycling, running, etc.
12
OBESITY
Pathology
Obesity is a public health challenge because of its prevalence and its constant increase.
According to the data of the ObEpi 2006 survey, the prevalence of obesity (≥ 30 kg/m2) in
France in individuals aged 15 and over was 12.4%. The prevalence of subjects with a BMI
≥ 40 kg/m2 was 0.8% (i.e. 380,000 people).
Consequences
Obesity has health consequences which range from an increased risk of premature death to various non-mortal diseases with undesirable effects on quality of life (high blood pressure, hypercholesterolaemia, alteraon to glucose tolerance, Type 2 diabetes or some hormone dependent and gastro-intesnal cancers).
Body Mass Index
BMI (Body Mass Index) is a reflecon of your excess
weight. Your BMI is obtained by dividing your weight
in kilos by your height squared.
Waist Measurement
To measure the waist, a tape measure should be used
placed as shown in the diagram below.
Example
You weigh P= 65 kg You measure T= 1.65 m
Your BMI: P/T² = 23.9 kg/m²
The interpretaon of BMI is performed in accordance
with the criteria defined by the World Health Organisaon (WHO)
Various thresholds have been set for analysing the
waist measurement: the threshold where the subject
must not put on weight (94 cm for men and 80 cm for
women) and the threshold where the subject must
lose weight (102 cm for men and 88 cm for women).
A waist measurement above these thresholds is
considered to be a cardiovascular and insulin
resistance risk factor.
13
CURRENT CARE AND OBESITY TREATMENTS
Treatment for obesity is global, mul-disciplinary and long-term. It involves
various complementary therapeuc approaches. The intra-gastric balloon
is offered as a non-surgical reversible technique for obesity.
Care and treatment without medicaon
The approaches are complementary and include regular
physical acvity, advice on diet (including reducon in
energy intake), cognive behavioural approaches,
psychological and/or psychotherapeuc support, and
personalised medical follow-up.
The combinaon of physical acvity (30-45 minutes, 4 to
5 mes a week), behavioural therapy and a low calorie
diet make it possible to obtain an average weight loss of 4.6 kg at one year.
Treatment with medicaon
In France, 2 medicines with different modes of acon
have markeng authorisaons: sibutramine (Sibutral)
and orlistat (Xenica, Alli). Neither of these is reimbursed.
They are indicated in obese paents (BMI > 30 kg/m2) or
overweight (BMI > 27-28/m2) paents with associated
risk factors, and if dietary measures have failed.
In comparison with a diet alone, the treatment with
medicaon leads to an addional weight loss of 3-4 kg but the weight loss
is not maintained when treatment is stopped.
14
Surgery for obesity or bariatric surgery
There are two major types of
Gastric
band
operaon:
those
based
By pass
exclusively on gastric restricon
and those involving intesnal
malabsorpon.
Obesity surgery is indicated in adult paents with a BMI > 40 kg/m2 or
even with a BMI > 35 kg/m2 associated with at least one comorbidity
likely to be improved aer surgery as second intenon aer the
failure of medical, dietec, nutrional and psychotherapeuc
treatment conducted well for 6-12 months.
All bariatric surgery techniques are effecve long-term (more than 10
years follow-up on average) on weight loss (average percentage loss of
excess weight between 40% and 80%, in the order of 25 to 60 kg), on
comorbidies (diabetes, high blood pressure (HBP), sleep apnoea
syndrome (SAS), hyperlipidaemia, etc.), and on quality of life.
In comparison with medical treatment, obesity surgery makes it
possible to reduce mortality by 10 years.
Technical descripon of the intra-gastric balloon
The intra-gastric balloon works by filling the stomach
which causes a feeling of saety and a reducon in
dietary intake.
Treatment by balloon is combined with dietec and
behavioural treatment
15
Quesons / Answers
How many kg will I lose with the balloon ?
The balloon makes it possible to lose between 10 kg and 25 kg in
6 months if it is combined with nutrional and behavioural
treatment. Connuaon of this treatment makes connued weight loss
possible aer removal of the balloon.
Will I regain weight aer the balloon is removed?
Connuaon of the nutrional and behavioural follow-up makes
it possible to avoid regaining weight aer the balloon is removed.
Dietary habits are not changed in 6 months. Stopping treatment aer
removal of the balloon exposes you to the yo-yo phenomenon.
Why must the balloon be removed aer 6 months?
The balloon becomes porous as a result of the gastric juices aer
6 months. The balloon may then deflate and move into the intesne.
There is a risk of intesnal obstrucon which would require an
emergency operaon.
In addion, the stomach gets used to the balloon aer 6 months and it
no longer causes a feeling of stomach fullness.
Can a second balloon be inserted if the desired weight has not
been lost during the 6 months?
Yes, aer at least 2 months so that the stomach is once again
sensive to the effect of the balloon.
How will I eat with the balloon?
Diet is normal several days aer inseron of a balloon. The faster
feeling of stomach fullness makes it possible to reduce the amounts
ingested and to follow the dietary changes advised by the nutrionist.
16
Will I be ill aer the balloon is inserted?
Stomach spasms, voming, and acid reflux are frequent in the 3 days
aer the inseron of the balloon. Before the inseron your doctor will
prescribe a treatment to reduce these side effects. Sick leave for 3 days
is prescribed. Somemes the symptoms may last for a week and
somemes they are treated by a short hospitalisaon. In rare cases,
the balloon has to be removed for intolerance.
Is the balloon covered by French social security?
The balloon is not covered by French social security. The endoscopy
performed before the balloon is inserted may be covered if the social
security centre has given its agreement. Removal of the balloon is not
covered by French social security.
What about pregnancy with the gastric balloon?
Pregnancy is contraindicated with the gastric balloon. Contracepon is
prescribed for women of childbearing age.
Will I feel the balloon in my stomach?
You will feel discomfort in the early days. Aer this, the main sensaon
created by the balloon is saety.
How long is the recovery aer the inseron of the balloon?
Plan at least 3 days rest in order to recover aer the operaon.
Starng work again depends on the ability of your body to adapt to the
intra-gastric balloon.
17
What are the differences in weight loss compared with other
slimming programmes?
You can expect to lose more weight with the intra-gastric balloon.
Give that the balloon produces a feeling of saety, you are more able
to control your diet and adopt healthy changes.
Does the balloon require frequent consultaons with the doctor
aer the inseron?
The follow-up programme is essenal to success and the adopon of
new life habits. You will see your doctor and your support team at least
once a month whilst the balloon is in place. During this period your
progress will be assessed and you will acquire significant medical and
nutrional knowledge as well as knowledge about physical acvity in
order to succeed in the long term.
Does the intra-gastric balloon limit acvies?
You must not plan any important acvity for the first week. Once your
body has adapted to the balloon, you can restart your usual acvies.
It is strongly recommended that you start a programme of physical
acvity to improve your chances of success.
What happens if the balloon leaks?
If the balloon leaks, you will note a change in the colour of your urine
(blue/green colour). Even though it is rare, this situaon can be serious.
If you see a change in the colour of your urine, you must call your doctor
18
immediately. He could then remove the balloon easily by the
endoscopic route without surgery. However, if you delay telling your
doctor there is a risk that the completely deflated balloon will migrate
into the digesve tract and be evacuated by the natural route. In the
worst case the balloon could create an intesnal obstrucon requiring
surgery. If the balloon deflates, it will probably be evacuated naturally
by your body. However, in some cases it may be necessary for your
doctor to remove it.
Must I take part in the follow-up visits to succeed?
The intra-gastric balloon is not a magis pill but a tool designed to change
your way of life. By taking part in the programme, you will benefit from
the training and support necessary for changing your habits and
increasing your chances of long-term success.
Can I eat everything I want? Are there dietary restricons?
You will not want to eat as much as you usually did beforehand.
In addion, if you eat sweet things or fay food, you risk having nausea.
Any excess food once the balloon is inserted is dangerous and may
cause serious medical problems.
How is the intra-gastric balloon removed?
The intra-gastric balloon is removed in the same way it was introduced,
i.e. through the mouth. This 20 minute procedure is performed under
anaesthec
19
20
Body mass index (BMI) table
Normal weight
Overweight
Obesity Class I
Obesity Class II (serious)
Obesity Class III (massive)
Classification of BMI
Height
(in metres)
BMI in kg/m2
Weight (in kg)
Body mass index (BMI) makes it possible to estimate the excess fat in the body and to define corpulence. The more the BMI increases the greater the risks linked to obesity.
To calculate BMI divide weight (in kg) by height (in metres) squared. BMI (kg/m2) = weight (kg) / height (m) x height (m).
21
160
150
140
130
120
110
100
90
80
70
60
Weight (kg)
1
2
3
4
5
6
7
8
(put the exact value in the box)
Weight monitoring curve
9
10
11
12 Time (months)
22
135
130
125
120
115
110
105
100
95
90
85
80
75
70
65
60
Waist
measurement
140
(cm)
1
2
3
4
5
6
7
8
(put the exact value in the box)
9
Waist measurement monitoring curve
10
11
12 Time (months)
Digeson
Mouth: Here food is reduced to small morsels and mixed with saliva (secreted by the salivary glands) which
starts digestion.
Oesophagus: Due to its contractions it enables food to be transported from the mouth to the stomach.
Stomach: Food is mixed and placed in contact with the gastric juices which continue the digestion.
Duodenum (small intestine): The digestive secretions from the pancreas, liver, gall bladder and intestinal
cells finish the digestion of the food.
Jejunum and ileum (small intestine): The food, reduced to nutrients, is assimilated and passes into the
general blood circulation.
Colon (large intestine): This is where water absorption and the transport of unusable food residues take place.
Rectum: Solid waste (stools) is stored here until it is eliminated through the anus.
23
A SELECTION OF WEBSITES
DEDICATED TO EXCESS WEIGHT
(for information)
http://www. imc.fr
http://www. calories, pro
http://www.poidsideal.info
http://www.ballon-intragastrique.com
http://www.ballonintragastrique.fr
http://www.dietetique.lu
http://www.Obesity-diet.com
http://www.obesite-solution-chirurgie.com
http://www.obesite-sante.com
http://www.gros.org
http://www.doctissimo.fr
http://www.vivelesrondes.com
http://www.medisite.fr
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27
Tel. +33 (0)4 37 57 57 00
Fax +33 (0)4 37 57 57 01
[email protected]
www.endalis.com
Imprimerie • 04 77 36 77 65 • ST CYPRIEN
ENDBALL-IP/GB V1
Park Avenir II - Avenue Marcel Mérieux
F 69530 BRIGNAIS