Safety in bariatric surgery

1. How safe is bariatric surgery?
Presenter- Dr Toshib
Junior Resident (Surgery III)
Moderator- Prof Sandeep Aggarwal

2. Objectives
• History & Evolution
• Common procedures and complications
• Evidence of safety
• Myths and misconceptions
• How safe is it not to perform surgery?
• Safety in the COVID scenario
• Conclusion

3. History & Evolution
• Dr. Kremen and Varco developed Jejunoileal Bypass(1954).
• Over 30,000 intestinal bypass operations performed before its
complications were recognized as unacceptable.
• Eventually almost all had to be reversed (91 deaths).
• Dr. Edward Mason came up with safer gastric procedures, gastric
band and gastric bypass(1978).
• Scopinaro et al. extended gastric with biliopancreatic bypass and Hess
et al. described addition of a duodenal switch.

4. • The safety profile of Bariatric surgery has been a matter of concern
among patients and physicians alike.
• So much so that, Kuwait had to impose a ban on bariatric Surgery in
2013 for about 3 months, due to concerns about safety of Bariatric
Surgery.
• High quality evidences including RCTs and longterm studies have
shown remarkable efficacy & safety of bariatric surgery.

5. Common procedures
1) Restrictive- solely by limiting
intake (gastric banding, GS);
2) Malabsorptive- Interference
with digestion and absorption
(intestinal bypass); and
3) Mixed- limit intake and produce
malabsorption (gastric bypass,
duodenal switch).
c) Adjustable gastric band. d) Biliopancreatic diversion with duodenal switch
a) Gastric bypass.
b) Sleeve gastrectomy

6. RYGB
• First laparoscopic gastric bypass
performed by Wittgrove & Clark
in 1994
• Gastric Pouch
• Bypass

7. • Anastomosis- gastrojejunal
• Routing of the Roux Limb and
Closure of Mesenteric Defects

8. Complications
Higa et al, Surg Obes Relat Dis. 2011

9. Sleeve Gastrectomy
• Gagner in 1999 performed the
1st LSG.
• Initially used as the 1st step
procedure in BPD-DS, now used
standalone.
• Resection of approximately 80%
of stomach.

10. Complications of Sleeve Gastrectomy
Complication Incidence
(%)
Time
period
Strategies Prevention
Staple line leak
(m/c GE jn)
0.9–2.2 % Early > late DL+ T-tube placement/ drainage,
esophagogastric stent, percutaneous
drainage
Methylene blue leak
test.
Stenosis 0.1–3.9 % Late > early Endoscopy +balloon dilatation Avoid oversewing, safe
distance from bougie at
incisura.
Hemorrhage < 2 % Early > late Stabilize and resuscitate, Endoscopic /
lap control of bleed.
Staple line hemostasis.
GERD 0.5–31 % Late > early Long term PPI Pre-op identify, intra-
op HH repair
Incisional hernia < 1 Late > early
Wound infection Rare Early

11. Single Anastomosis
Duodeno-ileostomy
• Retrograde Tracing and Temporary
Tacking
• Sleeve Creation
• Duodenal Dissection and Transection
• Duodeno-ileostomy (DI)
• Anti-reflux Stitch

14. Complications
Complication %
SADI
(n/1328)
RYGB BPD-DS
Leak 0.6% 0.1–5.6% 0.5–6%
Ulcer 0.1% 0.6–20% 0.2–1.9%
Stricture 0.3% 0.4–23% 1.9–2.3%
Bile reflux 0.1% 0.9% -
Volvulus 0 2–17% -
Internal
hernia
0 0.5–16% 0.4–18%
A. Surve et al. Surgery for Obesity and Related Diseases (2018)
Zaveri et al, Obesity Surgery (2018)
Early Late

15. One anastomosis gastric bypass
(OAGB)
• Described by Carbajo,2005
• A 5–6-cm “anti-reflux” suture
approximates the mesenteric
border of the jejunal loop to the
lateral wall of the gastric pouch.
• Distal gastric pouch and the
antimesenteric border of the
jejunal loop.
• A side-to-side gastrojejunostomy
Carbajo M et al. Obes Surg. 2005;

16. Mini gastric bypass
• Described by Rutledge
• A long gastric conduit
• A wide gastrojejunal anastomosis
• End-to-side gastrojejunostomy.

17. Benefits
• Mesenteric Defects- OAGB
eliminated two of three
potential sites of internal
herniation.
• No Intussusception
• Easy Conversion to Roux-Y
Configuration

18. Complications
• Bile Reflux- 0.5-10% majority are
easily treated with once-a-day
PPI therapy. However refractory
cases may require revision to
Roux-Y gastric bypass
• Malabsorption – Excess weight
loss (0.2-1%). Biliopancreatic
alimentary limb length of
between 150 and 200 cm is
preferred.

19. Gastric Banding
• First performed by Cadiere in
1992
• Inflatable silicone Band placed
over upper stomach, to form a
small pouch.
• Once the leading bariatric
procedure in 2008–2010
• Over time the frequency of
complications increased up to 40% at
10 years

20. Complications of Gastric Banding
Complication Description Diagnosis Treatment
Band slippage
3–12%
Herniation of the stomach
caudally through the band,
causing obstruction
Upper GI series– evaluate
transit of contrast and
positioning of band
First – deflation of band, likely
laparoscopic removal of band
necessary
Concentric gastric
pouch dilatation
Global dilatation of the
gastric pouch secondary to
too tight of a band and
patient overeating
Upper GI series– pouch
dilatation without change
in positioning of the band
“Band holiday” – deflation of
band with gradual adjustments
after resolution of dilatation
Band erosion
0.23 to 8%
Migration of the band into
the lumen of the stomach
Upper endoscopy with
retroflexed view
Band retrieval, +/- replacement
or transition to another bariatric
procedure
Port/tubing issues
4.3–24%
Tubing disconnect or
breakage, port inversion
Abdominal X-ray,
fluoroscopy
Local vs laparoscopic procedure
to reconnect tubing or revise port
fixation
Port infection Abscess around port site,
fistula, or drainage around
port site
Abdominal X-ray, USG.
Upper endoscopy to rule
out band erosion
Drainage, possible local port
removal and replacement

21. Management of Complications
GI Leaks-
• acute (<= 7 days),
• early (1–6 weeks),
• late (6–12 weeks), and
• chronic (>12 weeks)
Procedure Leak Incidence Mortality Stent
Resolution
Reoperation
Sleeve 2- 4.7% 3.3- 9.1% 50- 100%
Bypass 1.7- 4.5% 2- 8.5%
Csendes et al, J Gastrointest Surg, 2010

22. Acute, Early Leaks Chronic leaks
• Nonoperative management,
• Reoperation with lavage +/- closure/
T-tube placement
• Intraluminal stenting
Simon, Obesity Surgery , 2013
• Endoscopic stenting/ glue
• Resection + esophagojejunostomy
/ Roux-en-Y reconstruction

23. Postoperative Bleeding
• Reported incidence ranges between 0% - 4.4%
ILB- Acute, early, late, chronic
IAB-
• Surgical- acute post-op(staple line, short gastric,
trocar site.
• Medical – Peptic ulcer

24. Acute and Early Bleeding
• Tachycardia- increase gradually
and cyclical
• IL- melena and hematemesis.
• M/c bleeding from gastric staple
line
• Resussitate- UGIE- CT

25. Late and Chronic Bleeding
• >30 days- IL > IA
• IOC- UGIE
• Double-balloon enteroscopy to
assess the excluded stomach and
duodenum (Ulcer/neoplasm)

26. Venous Thrombo-Embolism
• DVT – 0-5.4%
• PE – 0- 6.4% (Large studies <1%)
Risk factors
• Patient related
• Procedure related
ASMBS updated position statement- 2013

27. Methods to prevent VTE
• Early ambulation
• Lower extremity compression
• Graduated compression stockings
• IPC with SCD.
• Pharmacologic prophylaxis
• UFH
• LMwH
• Vena caval filter.
-Urbankova et al , Thromb Haemost. 2005
-Sachdeva Ref-Cochrane Database Syst Rev. 2010

28. Longitudinal Assessment of Bariatric Surgery
LABS-1
• A prospective, observational study, of 4,776 patients from 2005 to
2007.
• The procedures evaluated in this study included open and
laparoscopic Roux-en-Y gastric bypass, and laparoscopic adjustable
gastric banding.
• Primary goal - evaluation of short-term safety of bariatric surgery.

29. • (mean age- 44.5 years; 21.1% men; 10.9% nonwhite; median BMI-
46.5).
• RYGB- 3412 patients (with 87.2%- Lap)
• LAGB- 1198 patients;
• 166 patients- other procedures and were not included in the analysis.
• The 30-day mortality rate was an impressive 0.3%; and a major
complication rate of 4.3%.

30. • The LABS-1 30-day major complication rate (composite end point of
death, major thrombotic complication(DVT/PE), reintervention and
prolonged hospitalization) was
-- LAGB- 1.0 %
-- LRYGB- 4.8%
-- ORYGB- 7.8%
• MC being abdominal reoperation (2.6%) and endoscopic intervention
(1.1%).
30-day Mortality N= 18 ( 18/6118, 0.3%)
sepsis 33%
cardiac causes 28%
pulmonary embolism 17%

31. 30-day major complication rate

32. Critisism
• LABS-1 data underestimates the true morbidity and mortality of
bariatric surgery, as the procedures were performed by highly skilled
surgeons at high-volume centers of excellence .
• Previous research, however, has revealed that outcomes of both high-
volume and low-volume programs are similar between centers of
excellence and centers without said designation.

33. • Despite multiple coexisting conditions in severely obese
population,the 30-day mortality(0.3%) and major adverse outcomes
rate were surpisingly low.
• Characteristics of the patients (e.g., male gender, coexisting medical
conditions, and a higher BMI), and
• Characteristics of the operation (i.e., degree of invasiveness), of the
surgeon, and of the site have been thought to increase the risk of
adverse outcomes.

34. Bariatric surgery: an updated systematic review and
meta-analysis, 2003–2012 (2014)
• Of the 25,060 initially identified articles, 259 met the inclusion
criteria. (b/w 2003-2012)
• 164 studies were included (37 RCTs and 127 observational studies).
• 161,756 patients with mean age 45 years and BMI: 46 kg/m2
Hu Sin Chang et al. JAMA Surg 2014

35. • The post-surgery five years complication rate was 17% (11-23%)
and the reoperation rate was 7% (3-12%)
Peri-operative mortality Post-operative mortality Complication rate Reoperation rate
RCTs 0.08% [0.01%–0.24%] 0.31% [0.01%–0.75%] 17% [11%–23%] 7% [3%–12%]
OBSs 0.22% [0.14%–0.31%] 0.35% [0.20%–0.52%] 10% [7%– 13%] 6% [4%–8%]
OBSs Peri-operative mortality Post-operative mortality
AGB 0.07% [0.02%–0.12%] 0.21% [0.08%–0.37%]
SG 0.29% [0.11%–0.63%] 0.34% [0.14%–0.60%]
GB 0.38% [0.22%–0.59%] 0.72% [0.28%–1.30%]

36. • Gastric bypass (GB) -more effective in weight loss but associated with more
complications.
• Adjustable gastric banding (AGB) had lower mortality and complication rates; yet,
the reoperation rate was higher and weight loss was less substantial than GB
Hu Sin Chang et al. JAMA Surg 2014
Reoperation rate Complication rate
RCTS GB 3% [1%– 5%] 21%
SG 9% [1%–35%] 13%
AGB 12% 13%
OBSs GB 5% [4%–6%] 18%
SG 3% [2%–5%] 11%
AGB 7% 10%

37. How safe is metabolic/diabetes surgery?
Diabetes, Obesity and Metabolism 2014.
• Data extracted from ACS-NSQIP database.(374 sites in 2012)
• Patients with T2DM who underwent LRYGB or one of seven
procedures b/w Jan’ 2007 and Dec’ 2012 were compared.
• Of the 66,678 patients included, 16,509 underwent LRYGB
A. Aminian et al. Diabetes, Obesity and Metabolism 2014

38. • Gastric bypass cases had a mean age of 50±10.5 years and a mean
BMI of 46.5±8.4 kg/m2.
• LRYGB group had significantly higher ASA scores. Despite that, had
lower 30 day complication and mortality rates.
Baseline Characteristics of Diabetic Patients Who Underwent Gastric Bypass and Other Types of Surgery (n=66,678)
Variables* Lap RYGB CABG Infrainguinal Bypass
Lap Partial
Colectomy
Lap
Cholecystectomy
Lap Appendectomy Lap Hysterectomy
Total Knee
Arthroplasty
Gender (female), % 71.5 30.8 38.5 46.8 59.7 49.0 100.0 60.3
Age (year),
mean±SD
50.0±10.5 65.7±9.9 67.3±10.9 68.3±10.9 60.1±14.5 53.6±15.8 53.7±12.2 67.6±8.9
BMI (kg/m2),
mean±SD
46.5±8.4 31.5±6.6 29.1±6.3 31.4±6.9 33.3±8.3 32.4±8.3 36.8±9.4 35.6±7.5
Insulin use, % 37.4 42.1 55.7 28.0 33..3 41.0 25.9 23.8
Hypertension, % 79.0 91.2 90.0 83.7 76.8 65.5 70.4 87.6
ASA Score,
mean±SD
2.9±0.4 3.8±0.4 3.2±0.5 2.8±0.6 2.7±0.6 2.6±0.6 2.6±0.5 2.7±0.5
*All baseline variables of the comparator groups were statistically significant compared to the RYGB group (p < 0.001).

39. Early postoperative mortality rates

40. • The 30-day mortality risk for LRYGB is one-tenth that of
cardiovascular surgery
• Total knee arthroplasty, has higher complication rate and similar
mortality rate to that of LRYGB.
A. Aminian et al. Diabetes, Obesity and Metabolism 2014

41. Complication Rate LRYGB
COMPLICATIONS RATE
Need for transfusion 1.22%
Sepsis 0.81%
Pneumonia 0.66%
DVT 0.36%
Septic Shock 0.30%
Acute renal failure 0.22%
PE 0.22%
MI 0.16%
Stroke 0.05%
Composite complication
rate
3.43%

42. • Many physicians do not consider the option of surgery.
• One reason may be an incorrect perception of the risk-to-benefit ratio
of medical vs surgery in obesity and diabetes management
• LRYGB can be considered a safe procedure.
• With similar short-term morbidity, as that of common procedures
such as a cholecystectomy and appendectomy.
• Has a mortality rate similar to that of knee arthroplasty.

43. Bariatric surgery versus non-surgical
treatment for obesity
• The meta-analysis included 11 studies with 796 patients follow-up of
2 years.
• Allocated to bariatric surgery or Medical management
• Compared with non-surgical treatment, surgery leads to greater
weight loss and higher remission rates of T2DM and metabolic
syndrome.
• There were no cardiovascular events or deaths reported after
bariatric surgery.
V Gloy et al, BMJ 2013

44. Mean change in body weight Type 2 diabetes remission
V Gloy et al, BMJ 2013

45. Long term effects of surgery vs non-surgical
treatment
• The prospective, non-randomised Swedish Obese Subjects study
involved 4047 obese subjects (avg 10.9 years of follow-up)
• 2010- bariatric surgery and 2037 received conventional treatment.
• Bariatric surgery was associated with a long-term reduction in
overall mortality.
• Decreased incidence of diabetes, myocardial infarction, stroke and
cancer (significant in women)
L. Sjostrom, Journal of Internal Medicine, 2012

46. Surgical complications and postoperative mortality
• 89% operations were open
surgery.
• 5 deaths (0.25%) in surgical group
(<90 days)
• 292 (14.5%) had nonfatal
complication (<90 days)
• Mortality risk reduction was
almost 30%
L. Sjostrom, Journal of Internal Medicine, 2012

47. Bariatric Surgery Centre of Excellence(BSCOE)
• By ASMBS and ACS.
• 125 procedures/year
• Rigorous 3 yearly inspections
• Multidisciplinary team and care
• Reporting outcomes to national registry
• A total of around 823 centers throughout the United States are
certified as ASMBS Centers of Excellence.

48. • The standardisation of Bariatric care and Improvement in the surgical
techniques and perioperative management protocols has led to
continuous improvement of the safety profile.
• Mortality has decreased substantially from 1.5-2% two decades ago
to 0.1-0.3%.
• Safety of bariatric Surgery can be enhanced if performed in high
volume centers, if high risk patients are identified preoperatively and
if the appropriate procedure is tailored to the right patient.

49. Myths
• Obesity is a diet issue, which can be managed by conservative
methods.
• Bariatric surgery is cosmetic.
• Bariatric surgery is risky and morbid procedure.
• Bariatric surgery is performed only to decrease weight.
• Bariatric surgery leads to nutrition deficiencies.

50. COVID scenario- Safer through surgery
• ASMBS asserts that metabolic and bariatric surgery is NOT elective.
• These are life-saving surgery, with evidence confirming the survival
benefit over those treated without surgery.
• It creates long-term changes in metabolism and reduces or eliminates
multiple serious obesity-related diseases improving long-term health
and quality of life as well as survival.
• Appropriately termed “medically necessary time-sensitive surgery” or
“medically necessary nonemergent surgery,”
ASMBS Guidelines/Statements, 2020

51. • Obesity-related diseases have been identified as independent risk
factors for adverse outcomes in COVID-19 infection
• The local prevalence of COVID-19, the availability of testing, the
available resources, including hospital beds, ventilators and personal
protection equipment, as well as strategies to protect healthcare
workers and patients.
• In the era of COVID-19, “safer through surgery” for patients with
obesity may prove to be even more important than before.

52. Risk stratification for reintroducing bariatric surgery after the peak of
COVID-19 at the Cleveland Clinic

53. Conclusion
• The history of bariatric surgery has left a lasting impact and increased
myths and misconceptions.
• Metabolic and bariatric surgery is safe and increasing experience has
further reduced complication profile.
• Its safety is comparable to routine elective procedures.
• There is need to restart metabolic and bariatric surgeries as we live in
this COVID era.
• This can be achieved in a tiered approach.

54. THANK YOU