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• M A Y 2 0 0 1 •
NATIONAL AGENCY
FOR ACCREDITATION AND EVALUATION
Surgery
IN HEALTH (ANAES) for morbid obesity
The National Agency for Accreditation and
in adults
Evaluation in Health (ANAES) is a Public
Administrative Establishment established by the law
of 24 April 1996 reforming the public and private
hospital service, and by Decree no. 97-311 of 7 April
1997. This agency is continuing and consolidating
the missions of its predecessor ANDEM, and has
undertaken new activities, such as establishing an I N T R O D U C T I O N
accreditation procedure in public and private health
M edicinedevelopment of very
care establishments in France. today is seeing and its impact on matters of
rapid new public health;
ANAES’ Executive Director is Professor Yves Matillon, technologies for the prevention,
diagnosis and treatment of disease. • it helps health care
and the Agency is governed by an Administrative establishments provide the
Decision-makers in the health
Council. The Scientific Council is divided into two service and health care best response to patients’
sections, an Evaluation section and an Accreditation professionals have to make choices needs in order to improve
section. ANAES’ two missions are to establish the state and define strategies on the basis health care;
of knowledge concerning strategies for prevention, of criteria of safety, efficacy and
• it helps health professionals
benefit.
diagnosis and treatment of disease, and to promote define and implement the best
improvements in the quality and safety of care, both The National Agency for strategies for diagnosis and
in hospitals and in the independent sector. Accreditation and Evaluation in treatment, in conformity with
Health (ANAES) evaluates these the criteria to be met.
In response to a formal request from its various various strategies, produces a This document fulfils this mission.
partners (authorities, institutions, professional summary of available information The technological and economic
and disseminates its conclusions to information it contains has been
associations, etc.) or on the initiative of its Scientific
all partners involved in health care. independently produced using
Council, the Agency carries out evaluation studies Its role is to provide assistance with rigorous scientific methods and
using the explicit methods and principles which it has the individual and collective comes from a review of the
formulated, which are based on a rigorous analysis decision-making process: international literature and from
of the scientific literature and on the opinion of consultation with experts.
• it keeps the public authorities
health professionals. This work makes it possible for
informed of the state of
institutions and health professionals alike to base scientific knowledge, its
their decisions on the most objective information implications for medicine, Professor Yves Matillon
possible. organisation and financing, Executive Director
S
A D U L T The conclusions below are extracted from a report published by ANAES.
B A C K G R O U N D
Obesity is defined as an excess betes. The risks of obesity-related operations performed for obesity
of body fat resulting in impairment mortality and morbidity correlate over the last few years, mainly due
of health. In clinical practice, corpu- with the amount of excess weight. to the introduction of a new surgical
lence is measured by Body Mass technique, the insertion of
In most cases, obesity is treated by
Index (BMI), which relates body adjustable gastroplasty rings. There
multidisciplinary medical manage-
weight to the height of the individ- has been a slight increase in the
ment. Surgery for obesity is only
ual, i.e. weight (in kg) / height2 (in number of classical surgical proce-
considered in certain patients after dures for obesity which total about
I N
m2). Obesity is defined as a BMI this initial treatment has failed. 1 000 a year. However, over 7 000
of 30 kg/m2 or higher, and mor- French guidelines clearly specify the adjustable gastroplasty rings were
bid obesity as a BMI of 40 kg/m2 indications and contraindications for inserted during the year 2000 even
or higher. surgery for obesity, and describe the though the technique was only
O B E S I T Y
In France, the prevalence of obesity conditions under which it is per- introduced in 1994.
is growing. In adults, the current formed, and how it should be fol-
prevalence is estimated to be lowed up. In particular, they specify In view of this change in practice, 1
between 6% and 10% for men and that surgery should be reserved for ANAES has 2been asked by CANAM
between 7% and 11% for women. patients who have suffered from sta- and SNDLF to evaluate the benefit-
The prevalence of morbid obesity is ble (or worsening) obesity for at risk ratio of the principal surgical
less well known. In France, it has least five years despite multidisci- procedures for morbid obesity in
been estimated in adults to be plinary medical management. In adults.
between 0.2% and 0.3%, i.e. between addition, it should be proposed only
100 000 and 150 000 people. for patients presenting morbid obe-
The evaluation concerned the
Obesity is associated with many sity or severe obesity (BMI > 35) if
three main procedures carried
complications. First and foremost this is associated with comorbidity
out in France, i.e. insertion of
are those which increase cardiovas- factors.
adjustable gastroplasty rings,
M O R B I D
cular risk, particularly hypertension, However, in France there has been vertical banded gastroplasty and
hyperlipidaemia and type 2 dia- a considerable rise in the number of gastric bypass.
S U M M A RY
Two main types of surgical proce- tion. Gastroplasty rings reduce term results, expressed weight loss
dures are performed in France to try the volume of the stomach by in different ways, and contained
to reduce excess weight: putting a ring around the top of incomplete information, particularly
the stomach. in relation to the methods used and
1. Procedures which restrict stom-
F O R
ach capacity. These include gas- 2. Mixed procedures (gastric expression of statistical results. Simi-
troplasty (basically, vertical bypasses) combine a reduction in larly, patient follow-up was often
banded gastroplasty) and stomach capacity with a bypass to incomplete. In the virtual absence of
adjustable gastroplasty rings. the proximal small intestine, randomised controlled trials, any
They involve creating a very which also provides a certain conclusions on the superiority of
small volume (15 to 20 ml) stom- degree of malabsorption. any technique should be viewed
with great caution.
U R G E R Y
ach pouch, which forces the The literature review showed that
patient to limit their intake of the most commonly used efficacy
solid food. The term “vertical endpoint was weight loss, rather
Efficacy of surgery
banded gastroplasty (VBG)” than endpoints measuring quality of – Short-term efficacy judged by
covers a number of techniques life and impact on comorbidity fac- weight loss
used to reduce stomach volume tors, which were very rarely One year after the procedure, all
either by stapling or by transsec- addressed. Most papers gave short- three surgical techniques pro-
1 Caisse Nationale d’Assurance Maladie des Professions Indépendantes - the French National Health Insurance Fund for Independent Pro-
S
fessions.
2 Société de Nutrition et de Diététique de Langue Française - the French Language Society for Nutrition and Diet.
S
vided a substantial mean weight ulation follow-up incomplete and reports of stenosis of the gas-
loss of about –20 to –50 kg. Trials short term, complications not rou- trojejunal anastomosis and
using the gastroplasty ring tech- tinely recorded). This suggests that onset of stomal ulcers.
U R G E R Y
nique reported a mean loss of the reported incidence of complica-
45% of excess weight. For vertical tions is probably underestimated. – All three techniques have caused
banded gastroplasty and gastric functional complications such as
Classical postoperative complica- vomiting, heartburn with œsophagi-
bypass, the figures were 61% and tions in obese patients are parietal.
68%, respectively. tis or dysphagia. Gastric bypass also
They were reported more frequently causes diarrhoea, which may or
– Long-term efficacy judged by when a laparotomic approach was may not be associated with dump-
weight loss used.
ing syndrome.
Long-term maintenance of weight – Figures for early postoperative
loss was generally poorly docu- – Nutritional and metabolic compli-
death range from a mean of 0.1% for
mented, particularly in the case of rings to 0.35% for vertical banded cations, such as iron deficiency,
gastroplasty rings. For vertical gastroplasty and 0.5% for gastric vitamin B-12 deficiency and folic
banded gastroplasty, weight loss
F O R
bypass. Pulmonary embolism was acid deficiency, anaemia, and dis-
tended to be maintained to some the most common cause of death orders of the nails and hair, have
extent; patients reported that (up to 70% of cases for vertical also been reported with greater
their weight remained stable or banded gastroplasty and around frequency and severity for gastric
went up again slightly. Similar 50% for the other two techniques). bypass than for pure stomach
results were reported for gastric reduction techniques. Patient fol-
bypass, with a larger proportion – All three techniques carry the clas-
low-up should include regular
M O R B I D
of trials where weight loss was sical per- and postoperative com-
plications related to the surgery checking for such deficiencies,
maintained over time.
itself, together with certain compli- which should be prevented by
– Quality of life cations which are specific to each appropriate supplementation with
Quality of life was not addressed technique. Occasionally these micronutrients.
in any depth in the trials complications have required revi-
reviewed. In spite of the draw- sion surgery.
backs of the procedure, it seems • For gastroplasty rings: gastric
to have improved in patients who perforation, bleeding at the
had surgery, particularly in terms trocar site or related to the
of psychological impact. prosthetic material implanted
– Effect on comorbidities (suppuration or malpositioning
O B E S I T Y
The medical profession accepts of the port, migration or rup-
that substantial weight loss in an ture of the ring). Dilatation of
obese patient improves comor- the pouch is one of the most • THE FULL REPORT
bidities. However, this aspect of feared late complications, as it
efficacy has received virtually no may be complicated by acute CAN BE DOWNLOADED
attention in studies of surgery. volvulus, gastric necrosis or
perforation.
– Comparison between the vari- • For vertical banded gastro- FOR FREE FROM
ous techniques plasty: gastric fistulae, pul-
The few direct comparisons monary emboli and staple line
found in the literature review THE ANAES WEBSITE:
disruption. There have also
mainly concerned gastric bypass been reports of stenosis of the
and vertical banded gastroplasty. mouth of the anastomosis, caus- http : //www.anaes.fr
The studies were of medium ing dilatation of the pouch and,
I N
quality and showed that more more rarely, gastric erosions.
weight was lost after gastric OR
• For gastric bypass: some cases
bypass than after vertical banded of severe bleeding and deep
gastroplasty. abscesses. The incidence of http : //www.sante.fr •
A D U L T
staple line disruption is
Complications of surgery decreasing, with more recent
The trials addressing complications techniques involving transsec-
had many design deficiencies (pop- tion. There have also been
• THE POSITIONS AND RECOMMENDATIONS EXPRESSED IN THIS DOCUMENT ARE THOSE OF ANAES,
AND NONE OF THE EXPERTS CONSULTED IS REGARDED AS INDIVIDUALLY RESPONSIBLE FOR THEM •
S
C O N C L U S I O N
Obesity is an increasingly important tages in relation to the surgery
public health problem which usu- itself. It also has the advantages of
ally requires multidisciplinary man- being closer to the normal physio-
agement for prevention and treat- logical situation and of being
ment. reversible. However, it seems to
Indications, conditions for perfor- be slightly less effective in terms of
mance of surgery and type of weight loss than vertical banded
surgery for obesity are clearly gastroplasty and gastric bypass. In
defined in existing guidelines. addition, lack of follow-up means
that its long-term benefits have not T heofclinicalby DLepoutre MsikaDunderreportdirec-
produced
r
tion D Agnès
literature analysis and
r
Simon the
r
and Stéphane Beu-
were
The increased prevalence of obesity yet been evaluated.
and the use of new techniques zon.
– All three techniques may involve The report was supervised by D r Bertrand Xerri,
(laparoscopic approach, insertion of Head of the Technology Assessment Department.
gastroplasty rings) have resulted in complications common to any
type of surgery, together with
a large increase in the number of
surgical procedures performed. complications specific to the pro- D ocumentary research was carried help by
Emmanuelle Blondet, with the
Laurence Frigère.
out
of
cedure. These are rarely severe
When patients have been properly but often require revision surgery.
selected, the benefit-risk ratio for
vertical banded gastroplasty and In view of the inadequate long-term
evaluation of either efficacy or inher-
S ecretarial services were provided by Laurence
Touati and Hélène Robert-Rouillac.
gastric bypass is acceptable. This
also applies for gastroplasty rings ent risk of gastroplasty rings (notably
WORKING GROUP EXPERTS:
with regard to short-term evaluation risks relating to how the prosthetic
of the procedure. material is tolerated, and risk of • Dr Bruno Berthet, surgeon specialising in
migration of the ring into the stom- gastroenterology, Marseille;
The following points need to be ach), the working group was con- • Professor Martine Laville, endocrinologist,
emphasised: cerned about the extensive and Lyon;
– The gastroplasty ring technique is unevaluated diffusion of this tech- • Professor Jean-Pierre Marmuse, surgeon, Paris;
the simplest, which gives it advan- nique which is currently taking place. • Professor Bertrand Millat, surgeon, Montpellier;
• Professor Jean Mouiel, surgeon specialising in
gastroenterology, Nice;
P R O S P E C T S • Dr Catherine Pommet-Nicot, endocrinologist,
Lyon;
Evaluation of surgical techniques of obesity and the issue of comor- • Professor Monique Romon, nutritionist, Lille;
for obesity needs to be continued, bidities. • Dr Michel Scotte, surgeon, Rouen;
and in particular a more precise • Dr Chantal Simon, endocrinologist, Strasbourg;
Furthermore,
evaluation of adjustable gastroplasty • Professor Karem Slim, surgeon specialising in
rings needs to be conducted. – the incidence of complications gastroenterology, Clermont-Ferrand;
has to be known and needs to be • Dr Bassam Tantawi, surgeon specialising in
Trials should: better evaluated from exhaustive gastroenterology, Quincy s/Senart;
– be long-term trials: It is impor- recording of complications. It • Professor Jean-Marie Zimmermann, surgeon
tant to have a follow-up period should be possible to reduce their specialising in chest medicine and gastro-
equivalent to that reported in incidence; enterology, Marseille.
some trials of gastric bypass (10 to – quality of life should also be bet-
15 years);
– be controlled prospective trials
ter evaluated as such an evaluation
is a fundamental criterion entering W eANAES’ Scientificthank the members of
would like to
Council, who kindly
reread this document and provided useful criti-
which compare insertion of gas- into the assessment of both cism.
troplasty rings with older tech- surgery and medical treatment.
niques (vertical banded gastro- The insertion of gastroplasty rings is
plasty, gastric bypass); increasing in France. The indica-
– ideally compare laparoscopic tions for their insertion need to be
Ag e n c e N a t i o n a l e
procedures in view of their complied with, and the procedure d’A c c r é d i t a t i o n e t
to be used for follow-up of surgery d’É v a l u a t i o n e n S a n t é
increasing use in this type of
needs to be defined. Information
surgery;
derived from medical device vigi-
159, rue Nationale - 75640 Paris cedex 13
– include an economic arm which lance reporting may also be useful Tel. : +33-1 42 16 72 72 - Fax : +33-1 42 16 73 73
would address direct and indirect in documenting the safety of these http : //www.anaes.fr
costs incurred by the management devices. http : //www.sante.fr
