ASMBS MANGA COMO BARIATRICO 2017
ASMBS MANGA COMO BARIATRICO 2017
ASMBS MANGA COMO BARIATRICO 2017
PII: S1550-7289(17)30377-5
DOI: http://dx.doi.org/10.1016/j.soard.2017.08.007
Reference: SOARD3097
To appear in: Surgery for Obesity and Related Diseases
Cite this article as: Mohamed Ali, Maher El Chaar, Saber Ghiassi, Ann M.
Rogers and Shanu N. Kothari, American Society for Metabolic and Bariatric
Surgery Updated Position Statement on Sleeve Gastrectomy as a Bariatric
P r o c e d u r e , Surgery for Obesity and Related Diseases,
http://dx.doi.org/10.1016/j.soard.2017.08.007
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ASMBS Guidelines/Statements
American Society for Metabolic and Bariatric Surgery Updated Position Statement on
Mohamed Ali MDa, Maher El Chaar MDb, Saber Ghiassi MDc, Ann M. Rogers MDd on behalf of
the American Society for Metabolic and Bariatric Surgery Clinical Issues Committee
a
Department of Surgery, University of California-Davis Medical Center, Sacramento, California;
b
Department of Surgery, Division of Bariatric and Minimally Invasive Surgery, the Medical
Hershey, Pennsylvania
Correspondence to:
Shanu N. Kothari, MD
La Crosse, WI 54601
Email: [email protected]
ASMBS Guidelines/Statements
American Society for Metabolic and Bariatric Surgery Updated Position Statement on
Preamble
The American Society for Metabolic and Bariatric Surgery (ASMBS) has previously
published 3 position statements on the use of sleeve gastrectomy (SG) as a bariatric procedure.1-3
These position statements were developed in response to inquiries made to the ASMBS by
patients, physicians, hospitals, health insurance payers, the media, and others regarding this
newer procedure that requires ongoing evaluation and evidence-based scrutiny. In 2012, the
procedure option.3 Since that time there have been a number of high-quality publications that
support the use of SG by demonstrating durable weight loss, improved medical co-morbidities,
and relatively low surgical risk. The Clinical Issues Committee and Executive Council of
ASMBS have determined that the emergence of SG as the most commonly performed bariatric
procedure in the world today worldwide warrants an updated statement in order to compile
available data to facilitate sharing of the evidence which supports the value of sleeve
gastrectomy, as well as to review available evidence regarding issues that may limit application
evidence and expert opinion. This statement is not intended to be, and should not be construed
as, stating or establishing a local, regional, or national standard of care for any bariatric
procedure.
significant weight loss. More recent studies have provided information comparing various
Y gastric bypass (RYGB) is felt by many to be the gold-standard procedure for weight loss and
Several studies demonstrate that SG and RYGB provide more comparable weight loss
than is seen following the adjustable gastric band (AGB) or non-surgical interventions.4-9 Leyba
et al. reported that SG and RYGB produced similar weight loss at one and five years of follow-
up.4,5 Peterli et al. reported early weight loss at 1 year after surgery to be comparable between
SG and RYGB in a randomized clinical trial.6 Vidal et al. reported no significant differences
between SG and RYGB in terms of excess weight loss (EWL) observed at 4 years of follow-up.7
Similarly, Lakdawala reported no significant early (1 year) difference in EWL between SG and
RYGB.8 Lim et al., although finding superior EWL after RYGB compared to SG at one year,
reported that the two procedures yielded similar weight loss results in the longer term of up to
five years.9 In a randomized trial of patients with a body mass index (BMI) <50 kg/m2, Kehagias
et al. found that SG yielded greater early weight loss, but this difference resolved over time
resulting in no weight loss difference between the two procedures by three years of follow-up.10
Karamanakos et al. also noted greater weight loss with SG than RYGB at one year, associated
with a statistically significant decrease in fasting ghrelin levels after SG but not after RYGB,
although the SG group was younger than the RYGB group which could be a confounding
factor.11
Other groups have reported that RYGB provides superior weight loss to that seen after
SG.12-16 In a meta-analysis of the 2-year outcomes of bariatric surgery, Zhang et al. reported that
patients undergoing RYGB achieved a lower BMI and greater %EWL compared to SG.12 A
retrospective cohort study of U.S. military veterans undergoing RYGB or SG compared with
matched patients treated without surgery demonstrated that patients undergoing RYGB lost a
mean of 27.5% of body weight, compared to 17.8% in the SG group.13 The surgical groups in
this study however were not well matched as the SG patients were older, more likely to be male,
and more likely to have diabetes, thus calling into question these results.
weight loss at one year, but RYGB was found to be superior at five years.14 El Chaar et al.
reported greater overall weight loss with RYGB at two years postoperatively. In this study, the
subset of patients with BMI<40 kg/m2 yielded similar weight loss with both procedures at one
year, but EWL was less 2 years after SG compared to RYGB.15 In studies of super obese
patients (BMI ≥50 kg/m2), several studies have demonstrated significantly greater weight loss
and percent total weight loss with RYGB than with SG.16,17
In summary, studies comparing weight loss after SG and after RYGB demonstrate
variable differences between the two procedures with no reliable conclusion as to which
operation produces the greatest weight loss early after surgery. However, the weight of current
evidence appears to support the conclusion that RYGB provides greater EWL compared to SG
generally shown similarity between SG and RYGB, and superiority of both these procedures
compared to AGB.18 The results of two new randomized trials comparing SG to RYGB showed
similar weight loss outcomes and improvements in type 2 diabetes mellitus (T2D) and quality of
life (QOL) scores.6,19 In another randomized trial, the Surgical Treatment and Medications
Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial, Schauer et al. reported 5-year
outcomes comparing the effectiveness of SG and RYGB combined with medical therapy versus
intensive medical therapy alone for the treatment of T2D.20 The results showed significant
superiority of both procedures over intensive medical therapy alone in terms of glycemic control;
weight loss; reduction of medication use for T2D, lipids and hypertension (HTN); renal function;
and QOL scores. There was no significant difference between SG and RYGB in terms of
improvement of glycemic control, HTN, or lipid profiles, but there was a significant difference
in 5-year weight loss, favoring RYGB. The outcomes and conclusions of these three RTs are
summarized in Table 1.
In a large case-control study matched for age, BMI and gender, Boza et al. compared 811
SG patients with 786 RYGB patients; the improvement of T2D, HTN and lipid profiles were
similar for both groups at 1 year after surgery.21 In a report from the Michigan Bariatric Surgery
Collaborative comparing outcomes of SG, RYGB and AGB, SG was associated with remission
rates of 66% for T2D and 40% for hyperlipidemia at one year postoperatively. These rates were
significantly greater than with AGB but less than with RYGB. Remission of HTN (40%) and
obstructive sleep apnea (OSA) (57%) after SG was similar to that with RYGB and superior to
Four meta-analyses comparing SG to RYGB have been published since 2012, two of
which reported similar remission of T2D,12,23 and two of which reported superior outcomes with
RYGB for several comorbidities.24,25 Yip et al. analyzed 33 studies (N=1375), including 3
randomized trials, 18 prospective and 12 retrospective studies, and concluded there was no
significant difference in T2D remission at 1 and 3 years (SG 68% and 80% vs. RYGB 76% and
year follow-up, Li et al. found that RYGB conferred significantly greater remission or
hypercholesterolemia but a higher risk for complications and reoperation than with SG.25
comorbidities up to 7 years after surgery. Lemanu et al. reported a 42.9% remission of T2D at 5
years after SG and improvement in another 35.7%,26 while others have reported T2D remission
rates of 76.9% to 100% at five years27-30 and 83.8% at 7 years.31 The reduction in glycated
hemoglobin (HbA1c) after SG averages 1.7%-2.37% at one year, 1.8%-2.5% at three years, and
comparing complication rates after SG and RYGB found that SG was associated with
significantly fewer major complications within 30 days of surgery. There was a non-significant
trend toward fewer minor complications after SG compared to RYGB. Neither procedure was
found to have a higher readmission rate, reoperation rate, or 30-day mortality.32 The general
range of 30-day mortality and morbidity for SG in the current literature is 0-1.2% and 0-17.5%
respectively.33 Young et al analyzed 24,117 patients from the American College of Surgeons
National Surgical Quality Improvement Program (NSQIP) database in the years 2010-2011,
4945 of whom underwent SG and 19,172 of whom underwent RYGB. In this analysis, there was
a significantly greater number of RYGB patients with diabetes, chronic obstructive pulmonary
disease, HTN and smoking. However, the risk-adjusted complication rate was still significantly
lower overall among SG patients. The 30-day mortality rates of SG (0.1%) vs. RYGB (0.15%)
were both low and because of the small numbers, risk-adjusted mortality rates could not be
compared.34
Aminian et al. reported on 5871 SG cases from the NSQIP database over the period
2011-2012; the 30-day mortality rate was 0.5% and the overall rate of serious adverse events was
2.4%. Based on their analysis, they identified several factors that were predictive of adverse
events after SG, including a history of congestive heart failure, male gender, T2D, chronic
steroid use, increasing BMI, elevated preoperative total bilirubin level and low preoperative
hematocrit.35 A similar NSQIP study of 1005 bariatric patients > 65 years of age showed a 30-
day mortality rate of 0.6% for both SG and RYGB, and an overall 30-day morbidity rate of 9%
for SG and 9.1% for RYGB.36 The BariSurg multicenter randomized controlled trial in which
248 patients have been enrolled and blinded to undergo SG or RYGB will likely give us better
prospectively collected database comprising 6 bariatric centers and 5706 weight loss surgery
(WLS) patients, there were 17 patients (0.3%) with PVT, of whom 16 (94.1%) had undergone
SG.37 This particular complication requires heightened clinical suspicion on the part of
surgeons, as it will not be seen on CT scans without intravenous contrast. As PVT may prove to
be more common after SG than after other forms of WLS, this particular topic merits further
study. The mechanism of PVT after SG remains a matter of speculation at this time and no
complication.
Given the growing prevalence of severe obesity among adolescents, and the fact that
adolescent obesity predicts adult obesity, WLS among teens is becoming more accepted.38 In
addition, based on safety and efficacy data, there is a trend toward SG as the procedure of choice
for adolescents, although both RYGB and SG are routinely performed in teen WLS programs.39
One multicenter, prospective study of WLS in adolescents included 161 RYGB patients and 67
SG patients. Among the RYGB patients there was a mean 28% total body weight loss at 3 years
after surgery, and among SG patients, 26%. There were no mortalities attributable to WLS and
the major complication rate was 8%. Nutritional deficiencies were seen as with adult
populations, so the need for long-term follow-up was emphasized.40 As there is almost no
literature on the outcomes of adults who underwent WLS as teens, this area merits further study.
The effect of SG on GERD is controversial and, as a result, has been the subject of
extensive study. The existence and severity of preoperative GERD should be considered when
helping patients select the best surgical option. GERD is also an important postoperative
outcome variable after SG. In general, RYGB is considered an effective anti-reflux procedure in
patients with medically-complicated obesity and GERD. In contrast, early data suggested that
SG may worsen GERD and many recommended caution in offering SG to patients with GERD,
especially when it was severe.36 A growing body of literature, however, indicates that the rates
of development of de novo GERD and worsening of preoperative GERD after SG may be lower
than previously thought.28 While controversial, there is little evidence beyond expert opinion to
support the notion that pre-existing GERD should exclude patients from undergoing SG.
following SG. At the time of the 2012 updated sleeve position statement, some studies had
reported a significant incidence of de novo GERD following SG,41-45 but more recent systematic
reviews of this topic are inconsistent.46,47 De novo GERD has been reported to occur in 8-11%
of patients following SG,28,48-50 although one study reported an incidence of 26.7%.30 One study
at 5 years after SG reported de novo GERD in only 7.4% of patients.48 Thereaux et al. found that
when patients before and six months after SG were assessed by pH measurement, two-thirds of
patients showed evidence of acid reflux following SG, including some who were asymptomatic.
However, in patients with pre-existing GERD, SG did not increase the measured abnormalities.50
In the presence of hiatal hernia, SG with simultaneous hiatal hernia repair improved
symptoms or reduced the need for medications in 1/3 of patients with pre-existing GERD, while
de novo reflux developed in 15.6 % of previously asymptomatic patients.51 One study of 110
SG patients undergoing routine pre- and post-operative upper endoscopy at a mean 58 months of
postsurgical follow-up reported a 17.2% rate of newly diagnosed Barrett esophagus and a
symptoms.52
Improvement in GERD symptoms has also been reported following SG. A large
retrospective review, the Bariatric Outcomes Longitudinal Database (BOLD) from 2007 to 2010
with 4832 patients found the prevalence of preoperative GERD to be 44.5%. After SG, 15.9% of
these patients reported resolution of symptoms.47 SG has been reported to lead to remission of
comparison to RYGB, however, patients are more likely to require acid reduction medications
after SG.53
Finally, while expert consensus appears to support the preferential use of RYGB as
superior to SG in the presence of Barrett esophagus, not all authors consider this metaplastic
patients, further study of this issue, including evaluation of long term endoscopic findings after
SG, is needed.
Summary and Recommendations
studies comparing outcomes of various surgical procedures, confirm SG provides significant and
durable weight loss, improvements in medical co-morbidities, improved QOL, and low
complication and mortality rates for obesity treatment. In terms of initial early weight loss and
improvement of most weight-related comorbid conditions, SG and RYGB appear similar. The
effect of SG on GERD, however, is less clear, as GERD improvement is less predictable and
as a first-stage procedure in high-risk patients as part of a planned, staged approach. As with any
bariatric procedure, long-term weight regain can occur after SG and may require one or more of
consistent with the consent provided for other bariatric procedures and, as such, should include
the risk of long-term weight regain. In addition, as with all currently recognized bariatric
procedures, surgeons performing SG are encouraged to prospectively collect, analyze and report
practice and is not intended, nor should it be used, to state or establish a local, regional, or
national legal standard of care. Ultimately, there are various appropriate treatment modalities for
each patient, and surgeons must use their judgment in selecting from among the different feasible
treatment options.
The ASMBS cautions against the use of this position statement in litigation in which the
clinical decisions of a physician are called into question. The ultimate judgment regarding the
appropriateness of any specific procedure or course of action must be made by the physician in
light of all the circumstances presented. Thus, an approach that differs from the position
statement, standing alone, does not necessarily imply that the approach was below the standard
of care. A conscientious physician may responsibly adopt a course of action different from that
set forth in the position statement when, in the reasonable judgment of the physician, such a
course of action is indicated by the condition of the patient, limitations on available resources, or
advances in knowledge or technology. All that should be expected is that the physician will
follow a reasonable course of action according to current knowledge, the available resources, and
the needs of the patient to deliver effective and safe medical care. The sole purpose of the present
References
1. Clinical Issues Committee of the American Society for Metabolic and Bariatric Surgery.
2. Clinical Issues Committee of the American Society for Metabolic and Bariatric Surgery.
position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis
2012;8(3):e21-6.
4. Leyba JL, Aulestia SN, Llopis SN. Laparoscopic Roux-en-Y gastric bypass versus
laparoscopic sleeve gastrectomy for the treatment of morbid obesity. A prospective study
5. Leyba JL, Llopis SN, Aulestia SN. Laparoscopic Roux-en-Y gastric bypass versus
laparoscopic sleeve gastrectomy for the treatment of morbid obesity. A prospective study
7. Vidal P, Ramón JM, Goday A, et al. Laparoscopic gastric bypass versus laparoscopic
laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for the
11. Karamanakos SN, Vagenas K, Kalfarentzos F, Alexandrides TK. Weight loss, appetite
suppression, and changes in fasting and postprandial ghrelin and peptide-YY levels after
Roux-en-Y gastric bypass and sleeve gastrectomy: a prospective, double blind study. Ann
Surg 2008;247(3):401-7.
12. Zhang C, Yuan Y, Qiu C, Zhang W. A meta-analysis of 2-year effect after surgery:
14. Zhang Y, Zhao H, Cao Z, et al. A randomized clinical trial of laparoscopic Roux-en-Y
gastric bypass and sleeve gastrectomy for the treatment of morbid obesity in China: a 5-
16. Thereaux J, Corigliano N, Poitou C, Oppert JM, Czernichow S, Bouillot JL. Comparison
of results after one year between sleeve gastrectomy and gastric bypass in patients with
17. Celio AC, Wu Q, Kasten KR, Manwaring ML, Pories WJ, Spaniolas K. Comparative
18. Jackson TD, Hutter MM. Morbidity and effectiveness of laparoscopic sleeve
gastrectomy, adjustable gastric band, and gastric bypass for morbid obesity. Adv Surg
2012;46:255-68.
19. Keidar A, Hershkop KJ, Marko L, et al. Roux-en-Y gastric bypass vs sleeve gastrectomy
2013;56(9):1914-8.
20. Schauer PR, Bhatt DL, Kirwan JP, et al. Bariatric surgery versus intensive medical
gastric bypass versus laparoscopic sleeve gastrectomy: a case-control study and 3 years
22. Carlin AM, Zeni TM, English WJ, et al; Michigan Bariatric Surgery Collaborative. The
banding procedures for the treatment of morbid obesity. Ann Surg 2013;257(5):791-7.
23. Yip S, Plank LD, Murphy R. Gastric bypass and sleeve gastrectomy for type 2 diabetes: a
24. Li JF, Lai DD, Ni B, Sun KX. Comparison of laparoscopic Roux-en-Y gastric bypass
with laparoscopic sleeve gastrectomy for morbid obesity or type 2 diabetes mellitus: a
25. Li JF, Lai DD, Lin ZH, Jiang TY, Zhang AM, Dai JF. Comparison of the long-term
results of Roux-en-Y gastric bypass and sleeve gastrectomy for morbid obesity: a
26. Lemanu DP, Singh PP, Rahman H, Hill AG, Babor R, MacCormick AD. Five-year
results after laparoscopic sleeve gastrectomy: a prospective study. Surg Obes Relat Dis
2015;11(3):518-24.
remission of type 2 diabetes in morbidly obese patients after sleeve gastrectomy. Surg
28. Rawlins L, Rawlins MP, Brown CC, Schumacher DL. Sleeve gastrectomy: 5-year
laparoscopic sleeve gastrectomy as a primary bariatric procedure. Surg Obes Relat Dis
2014;10(6):1129-33.
31. Casella G, Soricelli E, Giannotti D, et al. Long-term results after laparoscopic sleeve
32. Osland E, Yunus RM, Khan S, Alodat T, Memon B, Memon MA. Postoperative early
33. Fischer L, Wekerle AL, Bruckner T, et al. BariSurg trial: sleeve gastrectomy versus
Roux-en-Y gastric bypass in obese patients with BMI 35-60 kg/m2 - a multi-centre
randomized patient and observer blind non-inferiority trial. BMC Surg 2015;15:87.
34. Young MT, Gebhart A, Phelan MJ, Nguyen NT. Use and outcomes of laparoscopic
36. Spaniolas K, Trus TL, Adrales GL, Quigley MT, Pories WJ, Laycock WS. Early
morbidity and mortality of laparoscopic sleeve gastrectomy and gastric bypass in the
38. Linden BC, Barnett SJ. Adolescent bariatric surgery. In Agrawal S (ed), Obesity,
Bariatric and Metabolic Surgery: A Practical Guide, New York, Springer International
39. Desai NK, Wulkan ML, Inge TH. Update on adolescent bariatric surgery. Endocrinol
40. Inge TH, Courcoulas AP, Jenkins TM, et al; Teen-LABS Consortium. Weight loss and
2016;374(2):113-23.
42. Hutter MM, Schirmer BD, Jones DB, et al. First report from the American College of
morbidity and effectiveness positioned between the band and the bypass. Ann Surg
2011;254(3):410-20.
43. Keren D, Matter I, Rainis T, Lavy A. Getting the most from the sleeve: the importance of
patients over 59 years: early recovery and 12-month follow-up. Obes Surg
2011;21(8):1180-7.
45. Chiu S, Birch DW, Shi X, Sharma AM, Karmali S. Effect of sleeve gastrectomy on
2011;7(4):510-5.
46. Oor JE, Roks DJ, Ünlü Ç, Hazebroek EJ. Laparoscopic sleeve gastrectomy and
2016;211(1):250-67.
47. DuPree CE, Blair K, Steele SR, Martin MJ. Laparoscopic sleeve gastrectomy in patients
2014;149(4):328-34.
gastrectomy as sole procedure in patients with clinically severe obesity (BMI </=50
49. van Rutte PW, Smulders JF, de Zoete JP, Nienhuijs SW. Outcome of sleeve gastrectomy
51. Samakar K, McKenzie TJ, Tavakkoli A, Vernon AH, Robinson MK, Shikora SA. The
52. Genco A, Soricelli E, Casella G, et al. Gastroesophageal reflux disease and Barrett's
medication use following gastric bypass and sleeve gastrectomy. Surg Endosc
2017;31(1):410-15.
(kg/m2)
comorbidity response,
quality of life at 12
months.
TBW at 12 mos.
Schauer et SG (47) 36.1 60 18.6% Bariatric surgery is
improvement.
SG = sleeve gastrectomy; RYGB = Roux-en-Y gastric bypass; BMI = body mass index; EMBIL
= excess body mass index loss; TBW = total body weight; GERD = gastroesophageal reflux