Safe and Effective Treatment of Obesity & Diabetes:Failure of the Band, Sleeve & RNYvsSuccess of the Mini-Gastric Bypass
Medical News: Bypass Surgery for Diabetes w Nonmorbid Obesity? Marlene Busko: Jun 04, 2013
BUT: Not metioned in the abstract:
22 serious complications in 60 RNY patients (36%);
2 most serious complications Anastomotic leaks (3.3%)
1 patient suffered anoxic brain injury.
RNY pts more likely to have Complications
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Sleeve, Band, RNY and the Mini-Gastric Bypass
1. Safe and Effective Treatment of
Obesity & Diabetes:
Failure of the Band, Sleeve & RNY
vs
Success of the Mini-Gastric Bypass
2. Medical News:
Bypass Surgery for Diabetes w Nonmorbid
Obesity?
Marlene Busko: Jun 04, 2013
• "In a new report,
RNY bypass in mildly to moderately obese
patients with uncontrolled diabetes had
better short-term glucose control and
weight loss than their peers who received
medications and lifestyle advice."
• JAMA. 2013 Jun 5;309(21):2240-9. Roux-en-Y gastric bypass vs intensive medical management
for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study
randomized clinical trial. Ikramuddin S, Korner J, Lee WJ, Connett JE, Inabnet WB, Billington CJ,
Thomas AJ, Leslie DB, Chong K, Jeffery RW, Ahmed L, Vella A, Chuang LM, Bessler M, Sarr
MG, Swain JM, Laqua P, Jensen MD, Bantle JP. Department of Surgery, School of Public Health,
University of Minnesota, Minneapolis, MN 55455, USA. ikram001@umn.edu
3. Medical News:
Bypass Surgery for Diabetes w Nonmorbid Obesity?
Marlene Busko: Jun 04, 2013
• BUT: Not metioned in the abstract:
• 22 serious complications in 60 RNY
patients (36%);
• 2 most serious complications
Anastomotic leaks (3.3%)
• 1 patient suffered anoxic brain injury.
• RNY pts more likely to have Complications
4. Obesity surgery-diabetes study shows pros and
cons By LINDSEY TANNER | Associated Press –
Tue, Jun 4, 2013
• "About a third of the 60 RNY's developed
serious problems within a year of the
operation"
• "That rate is similar to what's been seen in
previous studies of RNY Bypass"
• "the most serious complications —
infections, intestinal blockages and
bleeding"
5. Obesity surgery-diabetes study shows pros and
cons By LINDSEY TANNER | Associated Press –
Tue, Jun 4, 2013
• The most dangerous complication
occurred in
• one patient when stomach contents
leaked, leading to overwhelming infection,
leg amputation and brain injury.
• Lead author Dr. Ikramuddin called that
case "a fluke."
6. Obesity surgery-diabetes study shows pros and
cons By LINDSEY TANNER | Associated Press –
Tue, Jun 4, 2013
• Although RNY pts lost nearly 60 lbs
• Only 75% lowered sugar levels to normal
or near normal levels
• JAMA editorial says such devastating
complications are rare, but that
• "the frequency and severity of
complications ... is problematic"
7. We Must Ask For Better
than:
36% Serious Complications
3% Leak Rate
A case of brain damage and Leg
Amputation is NOT
"a fluke"
8. A CLARION CALL FOR BETTER
BARIATRIC SURGERY
• RNY and VBG FAIL to cut helathcare
costs or Lengthen Life in VA Studies (1)
• Bariatric Surgery; A History of
Complications & Failure
• We Need Better Bariatric Surgery
• We Simpler, Safer, More Powerful, More
Durable and Revisable and Reversible
9. Primary Objectives
• Obesity and Diabetes are Growing
Problems in India
• Surgery Can Successfully Treat Obesity
and diabetes in Both the Thin and Obese
Diabetic Patient
• The Band, the Sleeve and the RNY are
failed forms of Bariatric Surgery
• The Mini-Gastric Bypass is Both Very Safe
and Very Effective Over the Short and
Long Term
15. Surgery Can Successfully Treat Obesity and
Diabetes in Both the Thin and Obese
Diabetic Patient
• 2011: Lee et al. MGB vs SLEEVE
• 12 mos prospective study T2DM patients
• Results:
• Type 2 Diabetes resolved
• 93% MGB
16. RNY Bypass Surgery for Diabetes With
Nonmorbid Obesity? Maybe Jun 04, 2013
• 12-months, 28 participants (49%) RNY group and 11
(19%) in the lifestyle-medical management group
achieved the primary end points
• BUT
• 22 (36%) serious complications in the RNY group
• 2 most serious complications were anastomotic leak
3.3%!!,
• 1 patient suffered anoxic brain injury.
• Patients who underwent surgery were also more likely to
have nonserious adverse events such as nutritional
deficiencies.
• JAMA. 2013 Jun 5;309(21):Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and
hyperlipidemia: the Diabetes Surgery Study randomized clinical trial. Ikramuddin S, Department of Surgery, School of Public Health, University of
Minnesota, Minneapolis, MN 55455, USA. ikram001@umn.edu
17. Primary Objectives
• Obesity and Diabetes are Growing Problems in
India
• Surgery Can Successfully Treat Obesity and
diabetes in Both the Thin and Obese Diabetic
Patient
• The Band, the Sleeve and the RNY are failed
forms of Bariatric Surgery
• The Mini-Gastric Bypass is Both Very Safe and
Very Effective Over the Short and Long Term
21. SUCCESS CRITERIA
"IDEAL" WEIGHT LOSS SURGERY
• 1. Low Risk (SAFETY)
• 2. Major Weight Loss (EFFICACY)
• 3. Easily performed
• 4. Short operative times (SAFETY)
• 5. Outpatient or short hospital stay (SAFETY)
• 6. Minimal Blood Loss (SAFETY)
• 7. No Need for ICU Stay (SAFETY)
• 8. Minimal Pain
• 9. Very High Patient Satisfaction
• 10. A Good "Exit Strategy" (SAFETY)
22. SUCCESS CRITERIA
"IDEAL" WEIGHT LOSS SURGERY
• 11. Change Behavior & Preferences;
Marked Decrease in Hunger and Increased Satiety
• 12. Minimal Retching and Vomiting
• 13. Few adhesions or hernias (SAFETY)
• 14. Minimal impact on Heart and Lung Function (SAFETY)
• 15. Low Failure Rate (EFFICACY)
• 16. Low Cost
• 17. Short Recovery Time
• 18. Rapid Return to Work
• 19. Low Risk of Pulmonary Embolus (SAFETY)
• 20. Durable weight loss (EFFICACY)
23. SUCCESS CRITERIA
"IDEAL" WEIGHT LOSS SURGERY
• 21. Low Risk of Ulcer (SAFETY)
• 22. Fat Malabsorption; low cholesterol & CV risk (EFFICACY)
• 23. No Plastic Foreign Body (SAFETY)
• 24. Easily Verifiable Results; > 10 years of Results
(EFFICACY)
• 25. Low Risk of Bowel Obstruction (SAFETY)
• 26. Based upon sound surgical principles (SAFETY)
• 27. Independent confirmation of results (EFFICACY)
• 28. Healthy life after surgery (SAFETY)
• 29. Supported by LEVEL I Evidence; RCT (Controlled
Prospective Randomized Trial) (EFFICACY)
• 30. Block “Sweet Eater” Failures (EFFICACY)
24. The Band, the Sleeve and the
RNY are Failed forms of Bariatric
Surgery
Published Data
Expert Opinion
25. Summary: Band, Sleeve & RNY
• In Short:
• Band: Now fading = Very Safe/NOT Very
Effective at 5 yrs
• Sleeve: Popular = Not very Safe/Fading
Effectiveness
• RNY: By Every Measure Most Dangerous
Bariatric Surgery & Effectiveness "Issues"
31. RNY Bypass Surgery for Diabetes With
Nonmorbid Obesity? Maybe Jun 04, 2013
• After 12-months, 28 participants (49%) in the gastric
bypass group and 11 (19%) in the lifestyle-medical
management group achieved the primary end points
• BUT
• 37% serious complications in the RNY group
• 2 most serious complications were anastomotic leak
3.3%!!,
• 1 patient suffered anoxic brain injury.
• Patients who underwent surgery were also more likely to
have nonserious adverse events such as nutritional
deficiencies.
• JAMA. 2013 Jun 5;309(21):Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension,
and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial. Ikramuddin S, Department of Surgery, School of Public Health,
University of Minnesota, Minneapolis, MN 55455, USA. ikram001@umn.edu
33. 28,000 Patients
• Ann Surg. 2011 Sep;254(3):410-20
First report from the American College of
Surgeons Bariatric Surgery Center Network
28,000 Patients
Hutter MM, Schirmer BD, Jones DB, Ko
CY, Cohen ME, Merkow RP, Nguyen NT.
Department of Surgery, Massachusetts General
Hospital, Boston, MA 02114, USA.
mhutter@partners.org
39. Published Data:
ACS Study 28,000 pts: Conclusions
• Lap Band: Very Safe but 5 year Failure
• Sleeve: More Dangerous than Band and
following Band's track to 5 yr failure
• RNY: More effective but studies clearly
show long term weight regain and
recurrence of Diabetes
• RNY: Clearly the most dangerous Bariatric
Surgery (Remember 36% serious
complications and 3.3% Leak rate)
40. In Short: Published Data:
ACS Study 28,000 pts: Conclusions
• Lap Band: Safe but Fails
• Sleeve: Danger >> Band + 5 yr failure
• RNY; More effective but Most dangerous
• Needed: Safety and Effectiveness
• Mini-Gastric Bypass
41. Sleeve Gastrectomy Failure:
• Sleeve gastrectomy and the risk of leak: a
systematic analysis of 4,888 patients.
• “Risk of leak is low at 2.4%." !!
• Surg Endosc. 2012 Jun;26(6):1509-15. Epub 2011 Dec
17. Aurora AR, Khaitan L, Saber AA. Department of
Surgery, University Hospitals Case Medical Center,
Cleveland, Ohio
43. Survey Results
• As part of a Pre-Conference survey for the
• MGB/OAB Consensus Conference
• Asked Expert Surgeons to Judge 4 weight loss
procedures.
• This is a report Expert Judgment of the Band,
the Sleeve, RNY and the MGB
44. 12. Your Opinion about the LAP BAND
• LAP BAND is good, short simple surgery,
maybe the best form of WLS, I use it often
7.1%
• LAP BAND is OK it is an acceptable
alternative and I use it sometimes 46.4%
• LAP BAND is a Bad operation and should
not be used 46.4%
48. Why the Band and Sleeve Fail
Restrictive Procedures and Sweet
and "Liquid Calories"
49. Band, Sleeve vs
the Neuro-Humoral Drive to Eat
• Restrictive Procedures
• MAKE SWEET EATERS:
• Mechanical Block of
Normal Healthy Foods
• Weight Loss: Honeymoon 2 years
• Then Failure Weight Regain
• GE Reflux
(Risk of Esophageal Cancer)
50. Band & Sleeve
Block Normal Healthy Foods
• Weight Loss =>
• Increased Hunger
• Decreased Satiety
• Healthy Foods Blocked
• Drive to Eat UP
• What Happens?
55. Summary
• Most Diets &
Restrictive Procedures (Band/Sleeve)
Will Fail
• Attempts to Override
Neuro-Humoral Hunger System
Routinly Fails
• R.P.s Force Patients into Pathological
Dietary Choices
• MAKE SWEET EATERS!
56. Primary Objectives
• Obesity and Diabetes are Growing Problems in
India
• Surgery Can Successfully Treat Obesity and
diabetes in Both the Thin and Obese Diabetic
Patient
• The Band, the Sleeve and the RNY are failed
forms of Bariatric Surgery
• The Mini-Gastric Bypass is Both Very Safe and
Very Effective Over the Short and Long Term
60. Mini-Gastric Bypass
• Blocks
Neuro-Humoral Hunger
System
• Short, Simple, Durable,
30 minute Surgery that:
• Decreases Hunger &
Increases Satiety
The Mongoose
He is a Little Bit Ugly, No?
64. One Thousand Consecutive Mini-gastric Bypass:
Short- And Long-term Outcome (Noun)
• 1,000 patients who underwent MGB
• Operative time and length of stay for MGB
• 89 min
• 1.8 days
• Short-term complications 2.7%
• Obes Surg. 2012 May;22(5):697-703. One thousand consecutive mini-gastric bypass: short- and
long-term outcome. Noun et al, Department of Digestive Surgery, HĂ´tel-Dieu de France Hospital
and University Saint Joseph Medical School, Naccache, Achrafieh, BP 166830 Beirut, Lebanon.
rnoun@wise.net.lb
65. One Thousand Consecutive Mini-gastric Bypass:
Short- And Long-term Outcome (Noun)
• 0.5% Leaks
• Four (0.4%) patients, severe bile reflux Rx by
stapled latero-lateral jejunojejunostomy (Braun).
• Excessive weight loss occurred in four patients
easily revised.
• Percent excess weight loss (EWL) of 73%
occurred at 18 months
• Obes Surg. 2012 May;22(5):697-703. One thousand consecutive mini-gastric bypass: short- and long-term
outcome. Noun et al, Department of Digestive Surgery, HĂ´tel-Dieu de France Hospital and University Saint
Joseph Medical School, Naccache, Achrafieh, BP 166830 Beirut, Lebanon. rnoun@wise.net.lb
66. 9 Year MGB Follow Up
Efficacy & Safety
• Excess weight loss and mean BMI 5 years after LMGB
was 72.1% and 27.1
• Of the 1322 patients, 23 (1.7%) reop surgery during a
follow-up of 9 years.
• The most common cause of revision was excess wt loss
in 9, followed by inadequate weight loss in 8, and bile
reflux in 3.
• No internal hernia or ileus during the follow-up period.
• Conclusion: MGB Excellent Durable Long Term Safe (No
Hernia/Bowel Obstruction)
• Surg Obes Relat Dis. 2011 Jul-Aug;7(4):486-91.Revisional surgery for laparoscopic minigastric bypass. Lee WJ,
Department of Surgery, Min-Sheng General Hospital, National Taiwan University, Taipei, Taiwan.
wjlee_obessurg_tw@yahoo.com.tw
67. 6436 CONSECUTIVE MINI-
GASTRIC BYPASSES: 16 YEARS
LATER
Robert RUTLEDGE1
1Director, Surgery, Center For Laparoscopic
Obesity Surgery, United States of America
68. Rutledge Results
• Mean preoperative weight
151 +/- 31 kg,
BMI 46 +/- 7. &
• 79% were female.
• Mean operative time 43 + 11 min
• Median length of stay 1 day.
• Three deaths occurred within 30 days of
surgery, (0.05%).
• None in the last 10 years.
69. Rutledge Results
• Early complications occurred in 4.9%.
• 44 (0.7%) patients had anastomotic leaks.
• Three (0.05%) patients presented with
dypepsia/bile reflux not responsive to medical
therapy and were successfully treated by Braun
side-to-side jejuno-jejunostomy.
• Gastritis/dyspepsia/marginal ulcer was the most
serious long term complication; routinely treated
medically.
70. Rutledge Results
• Excessive weight loss occurred in 1% of
patients; treated by take down of the bypass.
• Mean % excess weight loss (EWL) of 78%.
• 10 year weight regain 4.9%.
• >50% EWL was achieved for 95% of patients at
18 months and for 92% at 60 months.
• 6% of patient had inadequate weight loss or
significant weight regain were treated by
revision, (addition of ~2 meters to the bypass).
71. RNY Doubles the need for
hospitalisation
• In California from 1995 to 2004,
• 60,077 patients underwent RYGB-
11,659 in 2004 alone.
• The rate of hospitalization in the year
following RYGB was more than
double the rate in the year preceding
RYGB
• (19.3% vs 7.9%, P<.001).
• Hospitalization before and after gastric bypass surgery. Zingmond DS, McGory ML,
Ko CY. JAMA. 2005 Oct 19;294(15):1918-24.
72. MGB Decreases the Hospitalization
After Surgery
• The rate of hospitalization after MGB
• Declined from 17% to 11% the year
after and
• 2/3 of these admisions were
unrelated to MGB
• Hospitalization before and after mini-gastric bypass surgery.
Rutledge R. Int J Surg. 2007 Feb;5(1):35-40. Epub 2006 Aug 10
73. 2011: Lee et al. MGB vs SLEEVE
• 12 mos prospective study 60 T2DM
patients
• Matched for DM duration, type of DM
treatment, and glycemic control
• Results
• T2DM resolved 47% SG and 93% GBP (p
= 0.02)
• Weight loss fasting glucose, Hgba1c waist
circumfrence all worse in SG
74. 2011: Lee et al. RYGB vs SLEEVE
(Efficacy)
• Controlled Prospective Trial: SG is only
HALF as effective as MGB in inducing
remission of T2DM
50% 90%
76. What Do the Experts Say?
Survey of 102 surgeons answered
detailed survey online.
Surgeons from 6 Continents and 23
countries.
The group reported on a
past year's experience with over 39,000
cases, Very experienced surgeons.
91. Leak Rate
• Leak Rate in New Multicenter trial
• 3.3%!!
• Roux-en-Y gastric bypass vs intensive medical management for the control
of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery
Study randomized clinical trial.
• Ikramuddin S, Korner J, Lee WJ, Connett JE, Inabnet WB, Billington CJ,
Thomas AJ, Leslie DB, Chong K, Jeffery RW, Ahmed L, Vella A, Chuang
LM, Bessler M, Sarr MG, Swain JM, Laqua P, Jensen MD, Bantle JP.
• JAMA. 2013 Jun 5;309(21):2240-9.
92. Expert Opinion In Summary
• Restrictive Procedures Fail (Band Sleeve)
• Starting at 2-5 Years
• Restrictive Procedures Push Patients towards
Liquid Calories
• (Can a Sleeve stop Coke!)(Can a Sleeve stop Coke!)
• Weight Regain is Common
• Acid Reflux 30%+
• Acid Reflux = Esophageal Cancer
95. 2006: Rubino et al.
Duodenal exclusion
• “This study shows that bypassing Duodenum
directly ameliorates type 2 diabetes,
• independently of effects on food intake, body
weight, malabsorption, or nutrient delivery to the
hindgut.”
• The Mechanism of Diabetes Control After Gastrointestinal Bypass Surgery Reveals a Role of the Proximal Small
Intestine in the Pathophysiology of Type 2 Diabetes. Rubino, Francesco, MD; Forgione, Antonello, MD;
Cummings, David E MD; Vix, Michel MD; Gnuli, Donatella MD; Mingrone, Geltrude MD; Castagneto, Marco, MD
(S); Marescaux, Jacques MD, FRCS Annals of Surgery; 244 (5): 741-749, November 2006
96. Outcome after gastrectomy in gastric
cancer patients with type 2 diabetes
• 403 gastric cancer patients with T2DM
• BMI % Reduction
• Duodenal Bypass:
• No Bypass 7.6%
• Bypass 11.4%
• Jong Won Kim, etal, Gangnam Severance Hospital, Yonsei University
College of Medicine, Seoul 135-720, South Korea, World J Gastroenterol.
2012 January 7; 18(1): 49–54.
97. Bile Acids: Critical Hormonal
Factors in glucose homeostasis
• Decrease in the bile acid pool results in
decreases in hemoglobin A1c, glucose
levels and improved insulin sensitivity.
• Duodenal bypass improve the success in
the resolution of diabetes.
• Combined procedures include duodenal
bypass which leads to decrease in bile
acid pool.
98. The Mini-Gastric Bypass
Excellent Operation with Results Reported on
Thousands of Patients Over the Past 10-15 years
• Survey Shows:
• Short, Simple, Effective, Durable,
• 30 min Operation with 1 day Hospital
Stay
• Lower Leak rate than Sleeve or RNY
• Best Weight Loss
• Easily Reversible, Revisable
99. Primary Objectives
• Obesity and Diabetes are Growing Problems in
India
• Surgery Can Successfully Treat Obesity and
diabetes in Both the Thin and Obese Diabetic
Patient
• The Band, the Sleeve and the RNY are failed
forms of Bariatric Surgery
• The Mini-Gastric Bypass is Both Very Safe and
Very Effective Over the Short and Long Term
100. Conclusions
• Sleeve: popular now; Relatively
Dangerous and shows Band's signs of
5 year failure and new onset GERD in
30%
• MGB short simple reversible and revisable
operation may be up to twice as effective
as Sleeve and has excellent long term
durability
101. Marginal Ulcer has been known since the
beginning GI Surgery
 MARGINAL, GASTROJEJUNAL OR PEPTIC ULCER
SUBSEQUENT TO GASTROENTEROSTOMY.
 Erdmann JF.
 Ann Surg. 1921 Apr;73(4):434-40.
102. UNINFORMED FEAR BILLROTH II
EDUCATED USE BILLROTH II
• 1. Gastric Cancer Declining Rapidly, > 50%
• 2. Gastric Cancer Cause:
Environmental Factors / Easily Prevented
Diet, Lifestyle changes and Rx of H. Pylori
(Avoid Etoh, smoking, processed & salted
meats and foods, seek high intake of fruits and
vegetables)
103. UNINFORMED FEAR BILLROTH II
EDUCATED USE BILLROTH II
• 3. Some studies Slight Increased Risk of
gastric cancer after 20 – 30 years (RR 1.5):
But: BII to Rx Ulcer =>
Ulcer => Increased Risk
• (Worried? Rx H Pylori, Eat healthy etc.)
• 4. Many Large Studies: No Increased Risk
Thousands of patients followed for Decades
104. UNINFORMED FEAR BILLROTH II
EDUCATED USE BILLROTH II
• 5. Endoscopic screening of Billroth II patients
is Not Recommended. Why? Low Risk!
• 6. General, Trauma and Oncologic surgeons
routinely use the Billroth II (Thousands of
publications)
• 7. 2007 ~16,000 BII procedures were
performed in the USA
105. Marginal Ulcers:
Achilles Heel of Gastric Bypass
 Management
 1. Warn Patients & Surgeon “Be Vigilant”
 2. Aggressive anti-H. Pylori Rx
 3. Aggressive use of Antacids
 4. Strict Avoidance of Ulcerogenic Agents
(NSAIDS, Etoh, Smoking, Coffee, Soda, Nitrates)
 5. Encourage: Probiotics, Yogurt, Fruits Vegetables
 BILE MAKES NO DIFFERENCE!!!