MGB in Obese Diabetics

K S KularDirector , Kular Hospital 

President , Kular Medical Education & Research Society

National Highway 1 , Bija , Khanna ,Punjab,India 141412

Mini-Gastric Bypass: 2 StepsStep 1: Gastric Tube; Step 2: Bypass

• Gastric Gastric TubeTube

• BypassBypass

Step 1: Creation of Gastric Tube

Step 2: Billroth IIGastro-Jejunostomy

Selecting a Surgical Procedure

Safety&

Effectiveness

Effectiveness

Data to Show

MGB Much More Effective than

Sleeve Gastrectomy

To “Bariatric” Surgeons:Never Forget YourGeneral Surgery!

General Surgery Answers to

Bariatric Surgery Questions

General Surgery:Treatment for Gastric Cancer

• ? General Surgery Management of Small Distal Gastric Cancer

• Ans: Distal Gastrectomy +Billroth I or Billroth II

Billroth I vs Billroth IIGastrectomy vs Gastrectomy + Bypass

• Primary Gastric Procedure (PGP)

• Vs

• Combined Gastric + Bypass (CGB)

• Which Leads to Greater Weight Loss?

• Which Leads to Greater Resolution of Diabetes?

• General Surgery Answer:

Outcome after gastrectomy in gastric cancer patients with type 2 diabetes

• 403 gastric cancer patients with T2DM

• BMI % Reduction

• Duodenal Bypass:

• BI: No Bypass 7.6%

• BII: Bypass 11.4%

• ** 50% Improvement **

• 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.

Outcome after gastrectomy in gastric cancer patients with type 2 diabetes

• 403 gastric cancer patients with T2DM

• Diabetes (Improved/Resolved)

• Duodenal Bypass:

• BI: No Bypass 36.7%

• BII: Bypass 51.8%

• ** 41% Improvement **

• 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.

Influence Of Gastrectomy For Stomach Cancer on

Type 2 Diabetes Mellitus For Patients With A Body Mass Index Less Than 30

Kg/M(2).

Kang KC, Shin SH, Lee YJ, Heo YS. J Korean Surg Soc. 2012 Jun;82(6):347-55.

Department of Surgery, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.

Gastrectomy for stomach cancer on type 2 diabetes (Kang)

• Conclusions:• Addition of foregut-bypass (MGB)• Improves the type 2 DM • better than Gastrectomy ALONE (Sleeve)• Diabetes remission is significantly higher

in those with duodenal bypass

Gastrectomy for stomach cancer on type 2 diabetes (Kang)

• 75 GCa Pts, 35 month FU• BI vs BII for resolution/Improvement in DM• Gastrectomy ALONE (Sleeve)

0% Resolved, 45% improved• Gastrectomy + BII (MGB)

22% Resolved, 85% Improved

Gastrectomy for stomach cancer on type 2 diabetes (Kang)

• The improvement rate of diabetes mellitus (DM) status was 7.46 times higher in B-II than in B-I patients.

• The method of reconstruction is the most powerful factor for the improvement of the disease after surgery

Gastrectomy for stomach cancer on type 2 diabetes (Kang)

• To treat Diabetes• Gastrectomy alone • Much Worse than• Gastric + Bypass

• Do Not Forget Your General Surgery Taining

J Gastrointest Surg. 2012 Jan;16(1):45-51

Gastrointestinal metabolic surgery for the treatment of diabetic patients: a multi-

institutional international study.

Lee WJ, Hur KY, Lakadawala M, Kasama K, Wong SK, Lee YC.

Department of Surgery, Min-Sheng General Hospital, No. 168, Chin Kuo Road, Tauoyan, Taiwan, Republic of China.

wjlee_obessurg_tw@yahoo.com.tw

Gastrointestinal metabolic surgery for the treatment of diabetic patients (Lakadawala)

• 200 patients, 172 (86%) underwent gastric bypass, 24 (12%) underwent sleeve gastrectomy

• Remission of T2DM was achieved in 72.4% of the patients. 

• “Individuals who underwent gastric bypass lost more weight & higher diabetes remission than sleeve pts“

• Bypass pts included mix of MGB and RNY (per Dr. Lee)

MGB vs Sleeve

Mini-Gastric bypass 

vs Sleeve Gastrectomy for type 2 diabetes mellitus: a Randomized Controlled TrialRandomized Controlled Trial

Lee WJ, Chong K, Ser KH, Lee YC, Chen SC, Chen JC, Tsai MH, Chuang LM.

Arch Surg. 2011 Feb

Lee MGB vs SleeveRandomized Controlled Trial

• Double-blind randomized controlled trial

• 60 moderately obese patients (body mass index >25 and <35) 

• Outcome was remission of T2DM (fasting glucose <126 mg/dL and HbA(1c) <6.5% without glycemic therapy)

• All completed the 12-month follow-up

Lee MGB vs SleeveRandomized Controlled Trial

• Remission of T2DM was achieved by

• 93% in the Mini-gastric bypass group

• 47% in the sleeve gastrectomy group

• (P = .02)

Lee MGB vs SleeveRandomized Controlled Trial

• Mini-gastric bypass 

• lost more weight,

• achieved a lower waist circumference, and

• Lower glucose, HbA(1c), and

• blood lipid levels than

• the sleeve gastrectomy group

Surgery Can Successfully Treat Obesity and Diabetes in Both Thin and Obese Diabetic Patients

• 2013: Kular Hospital

• 6 year study T2DM patients

• Results:

• Type 2 Diabetes resolved

• 98% of MGB

Animal Models ConfirmDuodenal Bypass Improves Effectiveness

Animal Models ConfirmDuodenal Bypass Improves Effectiveness

• “This study shows that • bypassing Duodenum • directly Improveses type 2 diabetes, • independently of • 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,); Marescaux, Jacques MD, FRCS Annals of Surgery; 244 (5): 741-749, November 2006

Effectiveness:Conclusion

Data Show

Animal Models, General Surgery Studies & Randomized Controlled Prospective Trials

MGB IS Much More Effective than

Sleeve Gastrectomy

Sleeve Gastrectomy Does Show Some Short Term Effectiveness But…

• Numerous studies Document • Short and Long Term Failure • After Sleeve Gastrectomy• (Following the Outcomes of the Lap Band)• Initial Success Followed by Failure• The pathway followed by all previous

Restrictive Procedures• Examples Follow…

First report from the American College of Surgeons

Bariatric Surgery Center Network

28,000 Patients• Ann Surg. 2011 Sep;254(3):410-20

• Hutter MM, Schirmer BD, Jones DB, Ko CY, Cohen ME, Merkow RP, Nguyen NT.Department of Surgery, Massachusetts General Hospital, Boston, MA 02114, USA.

Band

Sleeve

RNY

Band

Sleeve

RNY

Band

Sleeve

RNY

American College of Surgeons Bariatric Surgery Center Network 28,000

Patients

Data by 12 months

already shows failure of Sleeve

Examples of Sleeve Gastrectomy Failure:

• “Sleeve Gastrectomy and Risk of Leak: 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

“Risk of leak is low at 2.4%"

Air India Airlines

Releases the following statement:

“Risk of Airplane Crashes are Low at only 2.4%"

Increase in GERD & Erosive Esophagitis 1 year Sleeve Gastrectomy

• A significant increase in

• GERD

• Preop 12.1% vs. 1 yr PostOp 47%

• Erosive Esophagitis

• Preop 16.7% vs. 1 yr PostOp 66.7%

• after Sleeve P < 0.001

Increase in GERD & Erosive Esophagitis 1 year Sleeve Gastrectomy

• A significant increase in • GERD• Preop 12.1% vs. 1 yr PostOp 47% • Erosive Esophagitis • Preop 16.7% vs. 1 yr PostOp 66.7%• after Sleeve P < 0.001

• Surg Endosc. 2013 Apr;27(4):1260-6, Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults, Tai CM, Bariatric and Metabolic International Surgery Center, E-Da Hospital, Kaohsiung, Taiwan, ROC

Erosive Esophagitis Increases Risk of Esophageal Cancer

• Danish Nationwide cohort study using data from 33,849 patients 

• The incidence of cancer among patients with erosive reflux disease was significantly greater than that expected for the general population

• Standardized incidence ratio, 2.2 times95% CI, 1.6-3.0

• Clin Gastroenterol Hepatol. 2012 May;10(5): Erosive reflux disease increases risk for esophageal adenocarcinoma, compared with nonerosive reflux, Erichsen R, Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus N, Denmar

Failed Sleeve Converted to RNY; Sept 2012, Less 24 months!

• Failed Sleeve in Less than 2 yrs:

• Failed Weight loss or Failed Diabetes Rx

• SEVERE New Onset or Worsening Reflux symptoms

• Note: The Time to Failure less than 24 months.

• 30% Failures were for "Severe Reflux"!!!!

• Indications and Mid-Term Results of Conversion from Sleeve Gastrectomy to Roux-en-Y Gastric Bypass. Authors Gautier T, et al. Obes Surg. 2012 Sep 23. Département de Chirurgie Digestive, Caen University Hospital, Caen Cedex, France, gautier.tho@gmail.com.

Effectiveness:Conclusion

Data Show

Animal Models, General Surgery Studies & Randomized Controlled Prospective Trials

MGB IS Much More Effective than

Sleeve Gastrectomy

Effectiveness

Much More Effective than Sleeve

Effectiveness

Much More Effective than RNY

MGB More Effective than BPDDr Tacchino MGB vs BPD

• Weight Loss and Diabetes Resolution Following Mini-Gastric Bypass and Bilio-Pancreatic Diversion. Tacchino R., Rutledge R., Università Cattolica del Sacro

Cuore, Rome, Italy • 408 pts Jan 2007 to Dec 2009 • 36 months follow-up • Mini-Gastric Bypass (n = 164) initial BMI

46.4±9.6 or • Bilio-Pancreatic Diversion (n = 244) initial BMI

46.9±7 (Tacchino’s perferred Operation)

MGB More Effective than BPDDr Tacchino MGB vs BPD

• RESULTS: • Mean BMI at two years was 28.5±3.9 kg/m2 and

at three years 27.4±4.5 kg/m2 after MGB • BMI at two years 32.7± 6.04 kg/ m2 and at three

years 33.6±5.1 kg/m2 after BPD• One year resolution of diabetes was

accomplished in: • 100% in MGB group • 95% in BPD group.

MGB More Effective than BPDDr Tacchino MGB vs BPD

• Tacchino’s conclusions: • “Both MGB and BPD resluted in excellent weight

loss, excellent resolution of co-morbities with low risk of long term complications.

• The MGB was associated with greater weight loss than BPD.

• Improvements in other cardiovascular risk factors and quality of life were similar after both procedures.”

RNY Failure(It’s the Roux Limb that Fails)

Surg Endosc. 2012 Oct;26(10):2843-7. Epub 2012 Apr 27.Refractory and New-onset Diabetes more than 5 years after

RNY gastric bypass for morbid obesity.Yamaguchi CM, Faintuch J, Hayashi SY, Faintuch JJ, Cecconello I.

Hospital das Clinicas, ICHC Sao Paulo, 05403, Brazil.

Refractory and New-onset Diabetes After RNY gastric bypass (Yamaguchi)

• Patients submitted to Roux-en-Y gastric bypass were classified as PreOp DM, elevated FBG, and Non-DM, normal controls

• Follow-up was 7-9 years • 31.4 % (16/51) of Preop DM Without

Improvement• 15.2 % (7/46) of the Non-DM converted to

New Onset DM

Lap RNY Gastric Bypass

• TABLE 2. The Rate of Postoperative Complications of the L-GBP (RNY)

• Leak 4.5%• SBO 2%• PE 1%• Death 0.7%

• Ann Surg. 2004 May; 239(5): 698–703. Multivariate Analysis of Risk Factors for Death Following Gastric Bypass for Treatment of Morbid Obesity, Adolfo Z. Fernandez, Jr, MD et al.

RouxLimbMany Studies ofvarying roux limb lengths: 60 cm to 200 cm do not predict either absolute or excess weight loss

Bilio-PancreaticLimbMost operations entail a 40 cm biliopancreatic limb

50-70% Gut Bypass has No Effect on Fat and Calorie Absorption or on Body Weight

Experimental Evaluation of the Nutritional Importance of

Proximal and Distal Small Intestine Kremen, et al.

Experimental studies in dogs reveal that animals can be deprived of from 50 to 70 per

cent of their small intestine and maintain a near normal nutritional status.

Experimental Evaluation of the Nutritional Importance of Proximal and Distal Small Intestine

• Study showed that after sacrifice of major lengths of the proximal small intestine,

• the animal's weight is satisfactorily maintained near preoperative levels, and

• no great interference with fat absorption is observed.

Note: Duodenum is Preserved

Massive bypass = No Effect

• The small intestine in adults is a long and narrow tube about 7 meters (23 feet) long

• 50% Bypass = 11.5 ft (3.5 meters)• Minimal Weight Loss!• WHEN DUODENUM IS PRESERVED

What if the Duodenum is Bypassed?

What is Roux-en-Y Gastric Bypass Surgery?

• Roux-en-Y Gastric Bypass (RYGB) combines both

• Restrictive and • Malabsorptive • Components

The contribution of malabsorption to the reduction in net energy absorption after long-limb Roux-en-Y gastric bypass

• Roux-en-Y gastric bypass (RYGB) restricts food intake, and

• when the Roux limb is elongated to 150 cm, the procedure is believed to induce malabsorption

• Objective measure reduction calories after RYGB

• Restriction of food intake vs Malabsorption

• The contribution of malabsorption to the reduction in net energy absorption after long-limb Roux-en-Y gastric bypass, Elizabeth A Odstrcil, et al. Am J Clin Nutr October 2010 vol. 92 no. 4 704-713

The contribution of malabsorption to the reduction in net energy

absorption after long-limb Roux-en-Y gastric bypass

The contribution of malabsorption to the reduction in net energy absorption after long-limb Roux-en-Y gastric bypassElizabeth A Odstrcil, Juan G Martinez, Carol A Santa Ana, Beiqi Xue, Reva E Schneider, Karen J Steffer, Jack L Porter,

John Asplin, Joseph A Kuhn, and John S FordtranAm J Clin Nutr October 2010 vol. 92 no. 4 704-713

The contribution of malabsorption to the reduction in net energy absorption after long-limb Roux-en-Y gastric bypass

• No statistically significant effects of RYGB on

• Protein or • Carbohydrate

absorption coefficients

• The contribution of malabsorption to the reduction in net energy absorption after long-limb Roux-en-Y gastric bypass, Elizabeth A Odstrcil, et al. Am J Clin Nutr October 2010 vol. 92 no. 4 704-713

The contribution of malabsorption to the reduction in net energy absorption after long-limb Roux-en-Y gastric bypass

• 5 months after bypass, • Malabsorption reduced

absorption of combustible energy by 124 ± 57 kcal/d, whereas

• Restriction of food intake reduced energy absorption by 2062 ± 271 kcal/d

• In RNY Restriction 16 times more important than Malabsorption

• The contribution of malabsorption to the reduction in net energy absorption after long-limb Roux-en-Y gastric bypass, Elizabeth A Odstrcil, et al. Am J Clin Nutr October 2010 vol. 92 no. 4 704-713

The contribution of malabsorption to the reduction in net energy absorption after long-limb Roux-en-Y gastric bypass

• 14 months after bypass, • Malabsorption reduced

absorption of combustible energy by 172 ± 60 kcal/d, whereas

• Restriction of food intake reduced energy absorption by 1418 ± 171 kcal/d

• Restriction 8 times as important as Restriction

• (Why: Restriction Beginning to Fail)

• The contribution of malabsorption to the reduction in net energy absorption after long-limb Roux-en-Y gastric bypass, Elizabeth A Odstrcil, et al. Am J Clin Nutr October 2010 vol. 92 no. 4 704-713

The contribution of malabsorption to the reduction in net energy absorption after long-limb Roux-en-Y gastric bypass

• On average, malabsorption accounted for 6% and 11% of the total reduction in ccaloric intake at 5 and 14 mo, respectively, after 150 RNY gastric bypass

• RNY: Primarily a Restrictive Procedure

• NOTE: Early signs of failure

• The contribution of malabsorption to the reduction in net energy absorption after long-limb Roux-en-Y gastric bypass, Elizabeth A Odstrcil, et al. Am J Clin Nutr October 2010 vol. 92 no. 4 704-713

Safety

MGB Safer than Sleeve and RNY

Medscape Medical News: Bypass Surgery for Diabetes With Nonmorbid Obesity? Maybe

Marlene Busko: Jun 04, 2013

• "new report, RNY bypass in patients with uncontrolled diabetes

• better glucose control and weight loss than control"

• JAMA. 2013 Jun 5;309 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, et al. Department of Surgery, School of Public Health, University of Minnesota, Minneapolis, MN 55455, USA. ikram001@umn.edu

Medscape Medical News: Bypass Surgery for Diabetes With Nonmorbid Obesity? Maybe

Marlene Busko: Jun 04, 2013

• BUT Not metioned in the abstract:

• There were 22 serious complications

60 RNY pts (36%)

• 2 most serious complications Leaks (3.3%)

• 1 Leak pt suffered anoxic brain injury

• RNY pts more likely to have other Complications such as nutritional deficiencies.

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."

Bariatric surgery versus intensive medical therapy in obese patients with diabetes (Shauer)

• Serious adverse event• ReHospitalization RNY: 22%, Sleeve:

8%• Reoperation: RNY 6%, Sleeve: 2%• Leak: Sleeve 2%• Hernia (SBO?) RNY 2%• Hypoglycemia: RNY 56% Sleeve: 80%• Anemia (1yr): RNY: 12% Sleeve: 12%• Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S,

Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76

Bariatric surgery versus intensive medical therapy in obese patients with diabetes (Shauer)

• Serious adverse event• Anastomotic ulcer: RNY: 8%• Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood

B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76

6,436 MINI-GASTRIC BYPASSES:

16 YEARS LATER

Robert RUTLEDGE

Rutledge MGB Results

• Mean preoperative weight 151 +/- 31 kg, BMI 46 +/- 7. &

• 79% were female. • 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.

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 5%; routinely treated medically.

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)

MGB Resolved Diabetes In 93% At 3 Years

• Study in 1,202 Type II Dabetic MGB patients

• At three years Diabetes had resolved (no medication requirement) in 93% of patients.

Dr. K.S. Kular;

Kular Hospital

• 1054 pts (342 m 712 f), Age 38 yrs• Preop wt 128 kg mean BMI 43 kg/m2• Op-time 52 min, Hosp stay 2.5 days• Minor complications 4.6%• 14 major complications (1.3%)• Two leaks (0.2%) • Resolution Diabetes 98%• Anemia 68 pts (6.4%)• %EWL 48% 6 m, 84% 12 m & 91% 2 yrs

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

RNY vs MGB

• Resolution DM : 49% • Serious

Complications: 36%• Leaks: 3.3%

• Resolution DM : 98% • Serious

Complications: 1.3%• Leaks: 0.2%

Ikramuddin Kular & Manchanda

University of Minnesota Medical Center:

Ranked One BestHospitals in

America

Leak Rate 3.3%

Bleeding Ulcer 1.6%

Internal Hernia / Small Bowel

Obstruction 3.3%

Kular Hospital:Outcomes as

Good or Better than the Best Hospitals in

America

Leak Rate 3.3% 0.2%

Bleeding Ulcer 1.6%

Internal Hernia / Small Bowel

Obstruction 3.3% 0.0%

Excess weight loss was remarkably good,

48% 6 months, 85% 12 months and

91% at 2 years3 yrs 88% , 4 yrs 86% 5 yrs 87% 6 yrs 85%

Patterns of readmission and reoperation within 90 days after Roux-en-Y gastric bypass

• The <90-day all-cause ED visit, readmission, and reoperation rate was * 21% *

• Kellogg TA, Swan T, Leslie DA, Buchwald H, Ikramuddin S. Patterns of readmission and reoperation within 90 days after Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2009 Jul-Aug;5(4):416-23

Kular Hospital

• Confirms previous publications over past 16 years

• MGB is safe, low risk, effective & durable long term weight loss

• MGB works especially well in Indian pts

• Study is unique in shows good outcomes can also be expected in a community hospital setting in a smaller city in India

Selecting an Operative Procedure

Safety and Effectiveness

Personal Experience, Animal Models, Expert Judgment, Published Data and Controlled Prospective Randomized Trials all show:

MGB is More Effective than Sleeve & RNYMGB is Safer than Sleeve & RNY