Professional Documents
Culture Documents
T
he increased prevalence of obesity in Germany, par-
Summary ticularly among young adults, presents a challenge
to the healthcare system with major socioeconomic
Background: 3.9% of men and 5.2% of women in Germany suffer from second-
effects both now and in the future. According to the
degree obesity (body mass index [BMI] ≥ 35 to <40 kg/m2), and 6.5 million persons
DEGS1 study (2013), 5.2% of women and 3.9% of men
suffer from diabetes. Obesity surgery has become established as a further treat-
ment option alongside lifestyle changes and pharmacotherapy. in Germany suffer from second-degree obesity (body
mass index [BMI] ≥ 35 to < 40 kg/m2); 2.8% of women
Methods: The guideline was created by a multidisciplinary panel of experts on the and 1.2% of men suffer from third-degree obesity (BMI
basis of publications retrieved by a systematic literature search. It was subjected to ≥ 40 kg/m²) (1). It is stated in the German Health Report
a formal consensus process and tested in public consultation. on Diabetes for the year 2017 that 6.5 million persons in
the country now suffer from diabetes, 95% of whom have
Results: The therapeutic aims of surgery for obesity and/or metabolic disease are to
type 2 diabetes (2).
improve the quality of life and to prolong life by countering the life-shortening effect
Surgery for obesity and metabolic disease is less
of obesity and its comorbidities. These interventions are superior to conservative
treatments and are indicated when optimal non-surgical multimodal treatment has common in Germany than in the neighboring Western
been tried without benefit, in patients with BMI ≥ 40 kg/m², or else in patients with European countries (Germany, 10.5 procedures per
BMI ≥ 35 kg/m² who also have one or more of the accompanying illnesses that are 100 000 persons per year; Benelux countries, 99.3
associated with obesity. A primary indication without any prior trial of conservative procedures per 100 000 per year), and there are also
treatment exists if the patient has a BMI ≥ 50 kg/m², if conservative treatment is differences across the individual German federal
considered unlikely to help, or if especially severe comorbidities and sequelae of states (Länder) (3).
obesity are present that make any delay of surgical treatment inadvisable. Metabolic The currently available nonsurgical treatments for
surgery for type 2 diabetes is indicated (with varying recommendation grades) for weight reduction bring about sustained weight loss in
patients with BMI ≥ 30 kg/m², and as a primary indication for patients with BMI ≥ 40 only a small fraction of the persons treated and do not
kg/m². The currently established standard operations are gastric banding, sleeve lower mortality (4). The controversial designation of
gastrectomy, proximal Roux-en-Y gastric bypass, omega-loop gastric bypass, and surgical procedures as a “last resort” no longer ap-
biliopancreatic diversion. pears in the new guideline. Moreover, the expression
“bariatric surgery” has been replaced by “obesity sur-
Conclusion: No single standard technique can be recommended in all cases. In the
gery” in order to make it clear that such procedures
presence of an appropriate indication, the various surgical treatment options for
are a treatment for the disease called “obesity.”
obesity and/or metabolic disease should be discussed with the patient.
Readers are referred to the full guideline text for a
Cite this as: discussion of special aspects such as surgery in ado-
Dietrich A, Aberle J, Wirth A, Müller-Stich B, Schütz T, Tigges H: lescence or old age, pregnancy, perioperative man-
Clinical practice guideline: Obesity surgery and the treatment of metabolic diseases. agement, and details of the surgical techniques, and to
Dtsch Arztebl Int 2018; 115: 705–11. DOI: 10.3238/arztebl.2018.0705 the guideline report for methodological aspects (5).
Methods
The guideline was created in accordance with the S3
Integrated Research and Treatment Center (IFB) AdiposityDiseases, University Hospital Leipzig:
Prof. Dr. med. Arne Dietrich, Dr. rer. nat. Tatjana Schütz guideline specifications of the Association of Scien-
Department of Visceral, Transplantation, Thoracic and Vascular Surgery, University Hospital Leipzig: tific Medical Societies in Germany (Arbeitsgemein-
Prof. Dr. med. Arne Dietrich schaft der Wissenschaftlichen Medizinischen Fach-
III. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg: PD Dr. med. gesellschaften e. V., AWMF) under the aegis of the
Jens Aberle Surgical Working Group for the Treatment of Obe-
Bad Rothenfelde: Prof. Dr. med. Alfred Wirth sity (Chirurgische Arbeitsgemeinschaft für Adipo-
Department of General, Visceral and Transplantation Surgery, University of Heidelberg: sitastherapie, CAADIP) of the German Society of
Prof. Dr. med. Beat Müller-Stich
General and Visceral Surgery (Deutsche Gesellschaft
Department of General, Visceral and Vascular Surgery, Klinikum Landsberg am Lech:
Dr. med. Harald Tigges für Allgemein und Viszeralchirurgie, DGAV). The
* See eTable 1 for a comprehensive list of societies, associations, authors and collaborators involved guideline was issued by the CAADIP. The German
in the development of the S3 guideline Obesity Society (Deutsche Adipositas-Gesellschaft),
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the German Diabetes Society (Deutsche Diabetes duce the new category of “centers with special exper-
Gesellschaft), and seven other medical specialty so- tise.” Such centers are supposed to be certified by a
cieties and associations were represented on the specialty society, and the experience of the respon-
guideline commission, which also included a patient sible surgeon should comprise at least 300 obesity
representative (for a list of delegates, see eTable 1). operations.
A search for relevant publications (April 2009 to There was a strong consensus among the experts
March 2016) was conducted in the Medline, Coch- that the following types of patients should undergo
rane Library, and Scopus databases. Systematic re- surgery only in a center with special expertise, and
views, meta-analyses, and randomized controlled that the specified techniques should only be per-
trials (RCTs) were sought. formed in such centers (however, this is not evidence
The literature search yielded 9099 hits (after the based):
elimination of duplicates); after multilevel screening, ● Patients under age 18, or aged 65 and above
261 were chosen for further evaluation. Priority was ● Patients at elevated risk with severe comorbidities
given to systematic reviews and meta-analyses. Evi- (American Society of Anesthesiologists [ASA]
dence tables to be used as a foundation for the cre- score >3)
ation of the guideline were prepared for 56 systematic ● Patients with BMI ≥ 60 kg/m²
reviews and meta-analyses, one RCT, and five cohort ● Distal bypass operations, conversion operations,
studies; these tables were then evaluated by the SIGN and redo operations
procedure (6). Details are given in the guideline re- ● Procedures that are primarily for the treatment of
port (5) and in the eMethods. metabolic disease (in patients with BMI <40 kg/m²,
in collaboration with a physician who is an expert in
Major elements of the guideline and changes the treatment of diabetes/a diabetologist).
since the preceding version
Treatment objectives Surgical indications
In older guidelines, weight loss was often said to be the The treating team that establishes the indication for sur-
therapeutic objective of obesity surgery. Nonetheless, gery should consist of the following members:
empirical data on weight loss in kilograms, BMI points, ● A surgeon with competence in the surgical treat-
or percentage excess weight loss (%EWL) do not ad- ment of obesity and metabolic disorders
equately reflect whether the treatment has really ● An internist/general practitioner/physician with
achieved its objective. special expertise in nutrition who has competence
The newly formulated objective of obesity surgery in the surgical treatment of obesity and metabolic
and metabolic procedures is to bring about a sustained disorders
loss of weight and, through the beneficial effects of ● A mental health professional with experience in
weight loss, to achieve the following: obesity surgery
● Better quality of life ● A nutritionist or physician with special expertise in
● Remission, improvement, and/or prevention of the nutrition who has experience in obesity surgery
comorbidities and sequelae of obesity ● A physician who is an expert in the treatment of
● Longer survival diabetes/a diabetologist, if surgery for metabolic
● Continued participation in work and in social and indications (type 2 diabetes) is to be performed.
cultural activities. The term “obesity surgery” refers to any operation
The goals of treatment should always be individ- (e.g., sleeve gastrectomy) that is intended to bring
ually defined and adapted to any changes that take about sustained weight loss and thereby prevent or
place. This formulation met with a strong consensus improve obesity-associated comorbidities and im-
among the experts. prove the patient’s quality of life. The recommen-
dations of the current guideline of the German Obe-
Definition of centers sity Society (Deutsche Adipositas-Gesellschaft) (11)
Centers were defined in accordance with the certifi- and of the American guideline (12) have been
cation rules of the DGAV (7) and the Swiss guideline adopted.
on the surgical treatment of obesity (8). Obesity surgery is indicated in the following situ-
The Barmer Health Report (9) and current German ations:
registry data (10) reveal that perioperative morbidity ● In patients with BMI ≥ 40 kg/m2 without any co-
and mortality are lower in certified centers (e.g., morbidities or contraindications, when conser-
30-day mortality after Roux-en-Y gastric bypass: vative treatment options have been exhausted and
0.2% in certified centers, 0.5% in uncertified centers, after the patient has been thoroughly informed.
p = 0.002). There are also differences between the ● In patients with BMI ≥ 35 kg/m2, after the exhaus-
various types of certified center. For example, mor- tion of conservative treatment options, in the pres-
bidity was lower in reference and excellence centers ence of one or more obesity-associated comorbid-
than in competence centers (10). To take due account ities, such as: type 2 diabetes, coronary heart
of these data (even though their evidential quality is disease, congestive heart failure, hyperlipidemia,
not high), the guideline commission decided to intro- arterial hypertension, nephropathy, obstructive
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TABLE 2
*1 No data are available for percentage loss of excess weight after biliopancreatic diversion.
*2 proximaler Roux-en-Y-gastric bypass (RYGB), mini-bypass, and bypass procedures that were not further specified.
*3 High heterogeneity in definitions of diabetes remission between primary studies and systematic reviews.
Fields are left empty if no high-quality evidence on the level of a systematic review or a meta-analysis is available.
All evidence summarized here is from systematic reviews and meta-analyses with SIGN evidence level 2+/++. The evidence tables corresponding to the systematic reviews and meta-analyses
cited here are presented in the guideline report. CI, confidence interval
or even a remission of their diabetes. Many studies ● If the patient is in an unstable psychopathological
of high quality (RCTs and meta-analyses) have state, e.g., untreated bulimia nervosa or ongoing
shown the superiority of surgery over conservative substance dependence
treatment in these situations, justifying the recom- ● In the presence of underlying diseases associated
mendations above (15). with a catabolic state, malignant neoplasms, un-
Zhang et al., in a meta-analysis of 21 studies, treated endocrine disturbances, or other chronic
found a significant advantage of Roux-en-Y gastric diseases that could be made worse under the cata-
bypass (RYGB) over sleeve gastrectomy (SG) with bolic conditions brought about by the operation
respect to the rate of remission of type 2 diabetes ● If the patient is pregnant or intends to become
(odds ratio [OR] = 3.29, 95% confidence interval pregnant in the near future.
[CI]: [1.98; 5.49], p <0.001) (16). These contraindications are relative, except for
Schauer et al. performed a randomized controlled pregnancy, and they are not supported by evidence.
trial comparing conservative treatment versus SG or The decision should be made on the basis of an indi-
RYGB in patients with poorly controlled type 2 dia- vidualized, interdisciplinary risk–benefit analysis.
betes. Five years after treatment, 45% of patients in Decisions against surgery should be re-evaluated if
the RYGB group were in complete remission (normal the disease that was considered a contraindication has
HbA1c without antidiabetic medication); the figure in been successfully treated, or if the contraindicating
the SG group was only 25% (p <0.05) (17). psychopathological state has been stabilized.
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18.8 kg/m2 (95% CI: [18.9; 18.7]); RYGB, SG, sleeve gastrectomy; RYGB, proximal Roux-en-Y gastric bypass; BPD-DS, biliopancreatic diversion with
duodenal switch.
12.6 kg/m2 (95% CI: [20,1; 5,1]); AGB (adjustable These recommendations are for the prevention of deficiency states; dose adaptation is necessary for
gastric banding), 11.3 kg/m2 (95% CI: [13.4; 9.2]); patients with documented deficiency or corresponding symptoms. Regardless of the procedure performed,
sleeve gastrectomy, 10.4 kg/m² (95% CI: [15.0; 5.7]). adequate amounts of MVM cannot be given immediately postoperatively because of the temporary restric-
tion of food intake. Patients who have undergone surgery with techniques that cause more pronounced
The rate of complete remission of pre-existing type malabsorption (all distal bypasses with a short common channel or long alimentary and/or biliopancreatic
2 diabetes for all procedures combined was 64.7%, loops) should receive the same type of supplementation as patients who have had a BPD-DS procedure.
and the rate of improvement or remission was 89.2%. There are no data or recommendations on the appropriate duration of prophylactic supplementation after
LAGB (laparoscopic adjustable gastric banding) or SG. Patients who have undergone any type of bypass
The remission rate was highest after BPD/DS should receive supplementation for life. Depending on the type of surgical procedure and the patient’s
(99.2%; 95% CI: [97.0; 99.8]), followed by RYGB nutritional state, adequate intake of macro- and micronutrients may be at least partly achievable.
(74.4%; 95% CI: [66.9; 80.6]), SG (61.3%; 95% CI: After LAGB, an MVM preparation qd + 1200–1500 mg calcium + 3000 IU vitamin D are recommended.
[45.9; 74.8]), and AGB (33.0%; 95% CI: [16.1;
55.8]). Subgroup analyses revealed no statistically
significant differences across procedures with re-
spect to either weight loss or diabetes remission. [0.01; 0.24]), which is lower than that of laparoscopic
Long-term data are available, for example, from cholecystectomy. The perioperative morbidity in the
the SOS study (a prospective interventional study) RCTs was 17% (95% CI: [11; 23]), consisting mainly
(20). The mean weight loss among patients who of minor complications (18). The most common com-
underwent surgery was 18% at 20 years after the pro- plications of obesity surgery (all of them rare) were
cedure. These patients, in comparison to the conser- staple-line fistula, anastomosis insufficiency, abscess,
vatively managed control group, had lower overall and bleeding.
mortality (adjusted hazard ratio [HR] 0.71, 95% CI:
[0.54; 0.92]; p = 0.01) and lower rates of myocardial Postoperative care
infarction and stroke (adjusted HR 0.71, p = 0.02, and Meticulous postoperative care is indispensable and is
0.66, p = 0.008, respectively). supported by a strong expert consensus. The evidence
All of the standard procedures of obesity surgery regarding the proper extent of postoperative care is not
were rated as positive over the long term in a of high quality, but the outcome is clearly better in
risk–benefit analysis (18, 20, 21). patients who receive intensive postoperative care and
The perioperative morbidity and mortality of obe- participate in self-help groups (22). The key elements
sity surgery are relatively low. In the large-scale of postoperative care are the following:
meta-analysis of Chang et al. (18), the 30-day mortal- ● Checking whether the goal of treatment has been
ity of surgery in the RCTs was 0.08 % (95% CI: reached
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15. Müller-Stich BP, Senft JD, Warschkow R, et al.: Surgical versus 22. Kim HJ, Madan A, Fenton-Lee D: Does patient compliance with follow-
medical treatment of type 2 diabetes mellitus in nonseverely obese up influence weight loss after gastric bypass surgery? A systematic
patients: a systematic review and meta-analysis. Ann Surg 2015; 261: review and meta-analysis. Obes Surg 2014; 24: 647–51.
421–9. 23. Trastulli S, Desiderio J, Guarino S, et al.: Laparoscopic sleeve
16. Zhang Y, Wang J, Sun X, et al.: Laparoscopic sleeve gastrectomy gastrectomy compared with other bariatric surgical procedures:
versus laparoscopic Roux-en-Y gastric bypass for morbid obesity and a systematic review of randomized trials. Surgery Obes Relat Dis
related comorbidities: a meta-analysis of 21 studies. Obes Surg 2015; 2013; 9: 816–29.
25: 19–26. 24. Panunzi S, de Gaetano A, Carnicelli A, Mingrone G: Predictors of
17. Schauer PR, Bhatt DL, Kirwan JP, et al.: Bariatric surgery versus remission of diabetes mellitus in severely obese individuals under-
intensive medical therapy for diabetes—5-year outcomes. N Engl J going bariatric surgery: do BMI or procedure choice matter? A
Med 2017; 376: 641–51. meta-analysis. Ann Surg 2014; 26: 459–67.
25. Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachge-
18. Chang SH, Stoll CR, Song J, Varela JE, Eagon CJ, Colditz GA: The
sellschaften e. V.: Das AWMF-Regelwerk Leitlinien. www.awmf.org/
effectiveness and risks of bariatric surgery: an updated systematic fileadmin/user_upload/Leitlinien/AWMF-Regelwerk/AWMF-Regel-
review and meta-analysis, 2003–2012. JAMA Ssurgery 2013; 149: werk.pdf (last accessed on 12 March 2018).
275–87.
19. Yu J, Zhou X, Li L, et al.: The long-term effects of bariatric surgery for Correspondence address
type 2 diabetes: systematic review and meta-analysis of randomized Prof. Dr. med. Arne Dietrich
and nonrandomized evidence. Obes Surg 2014; 25: 143–58. Klinik für Viszeral-, Transplantation-, Thorax- und Gefässchirurgie
Universitätsklinikum Leipzig
20. Sjöström L: Review of the key results from the Swedish Obese
Liebigstr. 20, 04103 Leipzig, Germany
Subjects (SOS) trial—a prospective controlled intervention study of arne.dietrich@medizin.uni-leipzig.de
bariatric surgery. J Intern Med 2013; 273: 219–34.
21. Buchwald H, Estok R, Fahrbach K, et al.: Weight and type 2 diabetes ►Supplementary material
after bariatric surgery: systematic review and meta-analysis. Am J eMethods, eTables and eFigure:
Med 2009; 122: 248–56. www.aerzteblatt-international.de/18m0705
CLINICAL SNAPSHOT
Adhesions and Abdominal Pain: Ileal Perforation by a Sharp Ingested Foreign Body With
Mechanical Erosion at the Base of the Appendix
A 56-year old man presented to the emergency department with a Figure: Frontal recon-
2-day history of lower abdominal pain. Clinical examination struction of the contrast-
revealed pressure sensitivity in the right lower abdomen with local enhanced abdominal CT
shows a longitudinal
peritonism. Laboratory analysis showed a normal leukocyte count
radiodense foreign body
of 8790/µL but CRP elevation to 5.7 mg/dL. Sonography showed in the right lower
no clearly pathological findings. Subsequent computed tomography abdomen. This object
(CT) showed a radiodense structure (arrow). Urgent laparoscopic extends beyond the
intervention was converted to longitudinal lower abdominal lapa- bowel wall with projec-
rotomy owing to extensive adhesions. The intestinal perforation tion of the point towards
was located in the ileum, caused by a 3-cm-long fishbone; the base the cecum. In this area
of the appendix was involved. After removal of the bone, the per- there is an inflammatory
wall reaction in the
foration was repaired and the appendix resected. The patient
pericecal fatty tissue
recovered quickly and was discharged 5 days after surgery. He close to the base of the
must have accidentally swallowed the bone while eating a carp 3 appendix corresponding
days previously. Complications are described in only 1% of in- to the tubular structure
gested foreign bodies, but for sharp objects the rate rises to 35%. seen on the initial
sonogram.
Jens Strohäker, Dr. med. Robert Bachmann, Klinik für Allgemeine,
Viszeral- und Transplantationschirurgie, Universitätsklinikum Tübingen,
jens.strohaeker@med.uni-tuebingen.de
Conflict of interest statement: The authors declare that no conflict of interest exists.
Translated from the original German by David Roseveare
Cite this as: Strohäker J, Bachmann R: Adhesions and abdominal pain: ileal perforation by a sharp ingested foreign body with mechanical erosion at the base of the appendix.
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The guideline committee good or very good quality were not individually evaluated. If two
As required by the Association of Scientific Medical Societies in or more reviews overlapped in more than half of the studies that
Germany (AWMF), other specialty societies (i.e., societies other they included, only the review that was of the highest quality and
than the one mainly responsible for the guideline), corresponding had the most recent publication date was considered. In this way,
to the intended users of the guideline, were included in the com- the 261 publications chosen for analysis after full-text screening
mittee; a patient representative was included as well (eTable 1). were reduced to a set of 56 systematic reviews and meta-analyses
The conflict of interest statements submitted by all committee and, as requested by the experts, one RCT and five cohort studies.
members, as required by the AWMF, are incorporated in the PRISMA charts on the screening algorithm for the literature
guideline report (5). search on each topic, including reasons for the exclusion of pub-
lications, can be seen in the guideline report (eFigure) (5). In the
The literature search next step, data were extracted from the included publications and
The guideline was created in collaboration with the User- summarized in the form of evidence tables.
Group—Medizinische Leitlinienentwicklung e. V., CGS Clinical
Guideline Services, Berlin, and with the counseling and interac- Structured consensus-finding and formulation of the
tive support of the AWMF. The literature search and evaluation recommendations
were carried out by the UserGroup—Medizinische Leitlinienent- After formulation of the guideline text and recommendations, the
wicklung e. V. in collaboration with the guideline committee. On latter were evaluated and commented upon online in the frame-
the basis of questions formulated according to the PICO scheme, work of a formal consensus-finding process with two rounds of
and corresponding algorithms, a search for literature published voting, then discussed a final time in the subsequent structured
from April 2009 to March 2016 was carried out in the Medline, consensus conferences, where they were assigned recommen-
Cochrane Library, and Scopus databases. Systematic reviews, dation grades (eTable 3) and consensus strengths (eTable 4).
meta-analyses, and randomized controlled trials (RCTs) were The recommendation grades were assigned on the basis of
sought. the evidence, as well as further criteria such as the consistency
of study findings, the clinical relevance of the endpoints and ef-
Results of the literature search fect strengths, risk–benefit ratios, the applicability of the study
The literature search yielded 9099 hits (after the elimination of findings to the target group of patients and to the healthcare
duplicates), which were subjected to multilevel screening. 7920 system, the implementability of the recommendations in rou-
were excluded by screening of titles and abstracts, leaving 1179 tine care, patient preferences, and ethical and legal aspects.
for full-text screening. 833 were excluded, leaving 353 publi- Recommendations that were not study-based were desig-
cations that were intended to be used in the evaluation of the nated as “expert consensus.” These recommendations represent
literature on all key questions. After correction for publications good clinical practice still in need of confirmation by scientific
that were counted more than once because they were relevant to studies, or for which such confirmation cannot be expected
multiple key questions, and therefore appeared in multiple lit- because any relevant studies would be considered unethical.
erature groups, the number remaining for evaluation was 261. The resulting guideline text was submitted to all participat-
ing specialty societies (and by some of these to their respec-
Evaluation of the evidence tive membership), discussed in multiple rounds, and amended
The evidence was evaluated by the SIGN method (eTable 2) (6). as indicated. Compromises that were acceptable to the guide-
Systematic reviews and meta-analyses were given priority. RCTs line committee could be found on all points, so that no special
and cohort studies that were included in systematic reviews of votes were necessary.
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eTABLE 1
Composition of the guideline group: the participating specialty societies and associations and their delegates to the
guideline-creating committee (collaborators*)
eTABLE 2
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eTABLE 3 eTABLE 4
Recommendation grades, according to the AWMF (25) Adapted AWMF classification of consensus strength (25)
eFIGURE 1
Sleeve gastrectomy
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