A STRUCTURED APPROACH TO DECISION MAKING: CHOOSING · PDF fileA STRUCTURED APPROACH TO DECISION MAKING: CHOOSING THE BEST WEIGHT LOSS SURGERY ... 11. Change in eating ... Risk of gastric

A STRUCTURED APPROACH TO DECISION MAKING:

CHOOSING THE BEST WEIGHT LOSS SURGERY

R Rutledge MD,

The Centers for Laparoscopic Obesity Surgery

www.CLOS.net

Email: [email protected]

Dr. Rutledge

USA 001-702-714-0011 [email protected]

ARE YOU CONSIDERING THE MGB? WARNING:

THERE ARE “TRICKS AND TRAPS”

OFFER A SAFE AND SUCCESSFUL

MGB PROGRAM

• Please Call / Email: Anytime question or advice on any clinical,

technical or patient MGB question

• USA 001-702-714-0011 [email protected]

• Personal Visit: Dr Rutledge Visiting Prof: Costa Rica, Turkey,

France, Austria & India, Upcoming visits Greece, Istanbul, Czech

Republic, Italy and Germany

• Please Use the Knowledge of Others Before You Start;

Experience; over 14 years, over 6,000 patients


UPCOMING “HANDS ON” MGB IN INDIA

“TRICKS AND TRAPS” TRAINING PROGRAM

• Didactic Sessions

Talk with the Leading World Experts

• Hands On Surgery (with approval)

Scrub in on cases

Assist and

Participate in MGB Surgery

• This Fall and Next Year

• Bija India, Dr Rutledge & Dr Kular


STRUCTURED DECISION MAKING

TECHNOLOGY

• Research: Human Decision Making

frequently flawed & driven by irrational thoughts

• Selecting the Best weight loss surgery should be based

on a rational review of the data avoiding emotional or

irrational biases

• Structured Decision Making Technology:

• The PrOACT Methodology

DECISION MAKING ERRORS

Recent Research in Psychology and

Neurobiology Shows that:

The Human Brain is a Notoriously

Bad Decision Maker

HUMAN DECISION MAKING ERRORS

VERY COMMON

• Exaggerate Rare Events,

Downplay Common Events

(i.e. Fear Gastric Cancer vs. Fear Bowel Obstruction)

• Underestimate risks taken Willingly, (car)

Overestimate risks Beyond Control (airplane)

• Overestimate risks Talked About

IRRATIONAL ILLOGICAL THINKING

DECISION-MAKING ERRORS

• Confirmation Bias

(favor information that confirms preconceptions)

• Herd Behavior

(group think override rational)

• “Reptilian Brain”

Amygdala is part "impulsive," primitive system that

triggers emotional override rational thinking

PRIMITIVE RESPONSE SYSTEMS

MODIFY RISK ASSESSMENT

THE REPTILIAN BRAIN:

EMOTION & DECISION MAKING

• Rational logical thinking Frontal Lobe

• Amygdala Interferes with the Frontal lobe Primitive, Impulsive

• Irrational decision-making

IRRATIONAL ILLOGICAL THINKING

CONFIRMATION BIAS

• Contrary Evidence =>

Maintains or strengthens

present beliefs

• Overconfidence

in present beliefs

• Poor Decision Making

• Especially Present in

Organizations, Military, Political & Social Groups

REPTILIAN BRAIN POOR DECISIONS

FEAR LEADS TO JUDGMENT ERRORS

• Errors in Risk Assessment

• Death Airplane Crash

• Death Car Crash

• 1 in 1,000 patient / 20 years risk

of gastric cancer

• Bowel Obstruction from internal

hernia +16% in 5 years

SURGERY

HISTORY OF POOR

DECISIONS

JOSEPH LISTER:

AMERICAN SURGEONS

DELAYED ADOPTION OF

ANTISEPSIS 10 YEARS

REPTILIAN BRAIN

POOR DECISION MAKING

• Lister

published

antisepsis

paper:

• 1867

Dr. Gross; Gross Clinic 1875

HUMAN DECISION MAKING ERRORS:

EXPECTED, NOT RARE

• Realization of Fallibility

Human Decision Making

• Humility

• Socratic Questioning of

Assumptions

• Search for Logical & Rational

Decision Making Tools &

Techniques

PR.O.A.C.T METHODOLOGY

• PR: Define the Problem

• O: Objectives: Criteria for Success

• A: Alternatives: Available Options

• C: Consequences: Outcomes/Results

• T: Tradeoffs: Weigh Pros & Cons

• a systematic way to make decisions....

PR: STATE THE PROBLEM

• Obesity Epidemic

• History of Failure of Bariatric Surgical

Procedures

• Selecting the “Ideal / BEST”

Bariatric Surgical Procedure

PR: PROBLEM

A HISTORY OF FAILURE

Procedure Assessmemt

Jejuno-ileal Bypass (Failure)

Vertical Banded Gastroplasty (Failure)

Lap Band (Fail?)

RNY Bypass (Fail?)

BPD/DS (Fail?)

Sleeve: 5% Leak, 60-80% GE Reflux,

irreversible, weight regain

(Fail?)

1. Low Risk

2. Major Weight Loss

3. Easily performed

4. Short operative times

5. Outpatient or short hospital stay

6. Minimal Blood Loss

7. No Need for ICU Stay

8. Minimal Pain

9. Very High Patient Satisfaction

10. A Good "Exit Strategy"

O: OBJECTIVES, SUCCESS CRITERIA

"IDEAL" WEIGHT LOSS SURGERY


"IDEAL" WEIGHT LOSS SURGERY 11. Change in eating behavior and preferences; Marked

Decrease in Hunger and Increased Satiety 12. Minimal Retching and Vomiting 13. Few adhesions or hernias 14. Minimal impact on Heart and Lung Function 15. Low Failure Rate 16. Low Cost 17. Short Recovery Time 18. Rapid Return to Work 19. Low Risk of Pulmonary Embolus 20. Durable weight loss


"IDEAL" WEIGHT LOSS SURGERY

21. Low Risk of Ulcer

22. Malabsorption of fat; lowering cholesterol and CV risk

23. No Plastic Foreign Body

24. Easily Verifiable Results with over 10 years of Results

25. Low Risk of Bowel Obstruction

26. Based upon sound surgical principles and experience

27. Independent confirmation of results

28. Healthy life after surgery

29. Supported by LEVEL I Evidence; RCT (Controlled Prospective Randomized Trial Demonstrate Superiority)

30. Block “Sweet Eater” Failures

A: ALTERNATIVES

• RNY

• Band

• Sleeve

• MGB

MINI-GASTRIC BYPASS

• The Mini-Gastric Bypass

1997

• Vertical Gastric Tube

(Collis Gastroplasty)

• Gastric Bypass

(Billroth II Gastro-jejunostomy)

MINI-GASTRIC BYPASS

BASED SOUND SURGICAL PRACTICE

• Performed for

over 100 years

• 16,000 BII’s in

USA in 2007

• Operation of choice:

Trauma, Ulcers,

Cancer Stomach etc.

C: CONSEQUENCES/RESULTS

RNY Band SG MGB

1. Low Risk - + - +

2. Major Weight Loss + - - ++

3. Easily performed - - + + +

4. Short operative times - + + +

5. Short hospital stay - - + + +

6. Minimal Blood Loss - + + +

7. No Need for ICU Stay - + + +

8. Minimal Pain - + + +

9. High Patient Satisfaction - - - +

10. A Good "Exit Strategy" - - - + - - +


RNY Band SG MGB

11. Decrease Hunger

Increase Satiety + - + ++

12. Min Vomiting + + + +

13. No Int hernias - - - ++ ++ ++

14. Min Heart/Lung - - ++ ++ ++

15. Low Failure Rate - - - - - - ++

16. Low Cost - - - +

17. Short Recovery - + + +

18. Return to Work - + + +

19. Low Risk of PE - + + +

20. Durable wt loss - - - +

C: CONSEQUENCES / RESULTS

RNY Band SG MGB

21. Low Risk of Ulcer - + + -

22. Malabsorption of fat + - - +

23. No Foreign Body + - + +

24. Verifiable Results

>10 yrs of Good Results - - - ++

25. Bowel Obstruction - - + + ++

26. Sound surgical + - + +

27. Independent confirm - - - ++

28. Healthy life - - - ++

29. LEVEL I Evidence - - - ++

30. Block Sweet Eater + - - ++

T: TRADEOFFS

• Fear of Gastric Cancer \ Bile Reflux

• Rational vs. Reptilian Brain Decision Making

STATISTICAL ILLITERACY; "MANY DOCTORS

MISUNDERSTAND MEDICAL LITERATURE"

• Example: “In the absence of a Roux limb, the long-term effects of chronic alkaline reflux are unknown.”

• REALLY? Rational vs. Reptilian Brain thinking

• Billroth II >100 years and >1,450 papers on Billroth II

• Collins BJ, Miyashita T, Schweitzer M, Magnuson T, Harmon JW., Gastric

Bypass; Why Roux-en-Y? A Review of Experimental Data, Arch Surg. 2007; 142(10):1000-1003.

GASTRIC CANCER

RAPIDLY DECLINING

• The incidence of gastric

cancer in the United States

has

• Decreased four-fold since

1930

• Approximately 7 cases per

100,000 people.

BARIATRIC SURGEONS FEAR BILLROTH II;

CANCER SURGEONS CHOOSE BILLROTH II

• 1,490 articles on performance of the Billroth II

• General/Trauma/Oncologic surgeons commonly

use the Billroth II

• Over 16,000 Billroth II operation

performed in USA 2007

• While Bariatric Surgeons Fear the Billroth II

General Surgeons use the Billroth II routinely

BARIATRIC SURGEONS FEAR BILLROTH II

WHAT IS MAGNITUDE OF THE PROBLEM

• Mayo Clinic Study (Example)

• 338 Billroth II patients

• Followed 25-years

• 5,635 person-years

• Only 2 Cancers in 5,000+ pt years of Follow Up • Schafer et al, Risk of gastric carcinoma after treatment for benign ulcer disease.

N Engl J Med. 1983 Nov 17;309


MAGNITUDE OF THE PROBLEM

• Population based study, 338 Billroth II pts

• Followed 25-years


• Only 2 Cancers Found in 5,000 years

• Predicted 2.6 cancers (relative risk 0.8) Schafer et al, Risk of gastric carcinoma after treatment for benign ulcer disease. N Engl J Med. 1983 Nov 17;309


MAGNITUDE OF THE PROBLEM

• 338 Billroth II pts, Followed 25-years


• Only 2 Cancers in 5,000 pt years follow up

• RATE of Gastric Cancer is Declining

• 24 - 50% Expected Decrease from 1983

• Future risk ~1 patient / 5,000 pt years

ULCERS INCREASE RISK CANCER

• Meta-analysis:

7 studies Small increased risk

5 studies No Increased Risk

• Studies with increased Risk; Flawed

• Billroth II = Surgery Rx Ulcers

• ULCERS increase risk of Gastric Cancer!

• Ulcers and Gastric Cancer Common Etiology

=H. Pylori=

ULCERS INCREASE RISK CANCER

• 3,078 gastric cancer vs. 89,082 controlls

• Ulcer increases risk gastric cancer

=(relative risk 1.53)=

• Same as Increased Risk reported Billroth II

• Many other studies confirm these findings:

• Ulcer Increases Risk Gastric Cancer

• Ulcers & Gastric Cancer:

Common Etiology =H. Pylori=


GASTROENTEROLOGISTS IGNORE BILLROTH II

• Hundreds of thousands of people with Billroth II’s

• If cancer IS SUCH A BIG RISK…

• Shouldn’t gastroenterologists be looking for these

people, screening them with endoscopy?

• No, there is no recommendation for BII follow up

screening; Why? THE RISK IS LOW

• 63,000 yrs Follow up 23 cancers = Gen Pop.

RISK OF GASTRIC CANCER AFTER

BILLROTH II IS LOW

• Follow-up study of 1000 patients

• 22-30 year follow-up

• 196 endoscopy and biopsy No Cancer of the gastric

remnant seen

• Endoscopic screening will be “unrewarding”

• Br J Surg. 1983 Sep;70(9):552-4. Risk of gastric cancer after Billroth II resection

for duodenal ulcer. Fischer AB

WHAT CAUSES GASTRIC CANCER?

ITS NOT BILLROTH II

• Diets rich in fried, salted, smoked or preserved foods

increased cancer risk in many studies.

• Foods contain nitrites and these chemicals can be

converted to more harmful compounds (carcinogens) by

bacteria in the stomach.

• Diets high in fruit and vegetables protects against Cancer

• Stomach cancer is much more common in smokers and in

those with heavy alcohol intake.

• H. Pylori, No H. Pylori No Cancer

DIET AND CANCER PREVENTION

• Avoid ETOH, Tobacco, Processed & Preserved Meats, Salt

• RX H. Pylori,

• Eat Fruits and Veggies, Yogurt and

• Drink Green Tea

• Gonzalez CA, Cancer Research, Institut Català d'Oncologia, Av. Gran Via s/n, km 2.7, 08907 L'Hospitalet, Barcelona, Spain.

CANCER QUIZ: MORE DEADLY

CANCER CAUSING AGENT? A OR B

CANCER QUIZ: MORE DEADLY

CANCER CAUSING AGENT? A OR B

• American Institute for Cancer

Research

• 50 grams of processed meat

• Hot Dog / day

• Increase the risk cancer 21%

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)



• 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



• 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



• 8. Billroth II and the Mini-Gastric Bypass

Excellent and Effective surgical procedures

• 9. FEAR Gastric Cancer?

Avoid ETOH, Tobacco, Processed & Preserved Meats,

Rx H. Pylori,

Eat Fruits and Veggies, Yogurt and Drink Green Tea;

The Billroth II probably makes no difference

T: TRADEOFFS

• Fear Gastric Cancer / Bile Reflux

• Rational Thinking vs. Reptilian Brain

T: TRADEOFFS RATIONAL VS.

FEAR OF GASTRIC CANCER

• 1. Gastric Cancer Declining Rapidly

• 2. GC Environmental Causes; Easily Prevented

• 3. Some studies show Small Increased Risk

Probably from Ulcers/H. Pylori

• 4. Many large studies: NO increased risk

• 5. Endoscopic Screening: Not Recommended

• 6. General, Trauma & Oncologic Surgeons Use BII

T: TRADEOFFS


If you FEAR gastric cancer:

Avoid Alcohol, Tobacco,

Processed & Preserved Meats,

Rx H. Pylori,

Eat Fruits and Veggies, Yogurt and

Drink Green Tea;

Billroth II Probably Makes NO Difference

T: TRADEOFFS


A Billroth II Probably

Makes No Difference

T: TRADEOFFS


A Billroth II Probably

Makes No Difference


RNY Band SG MGB

1. Low Risk - + - +

2. Major Weight Loss - - - +

3. Easily performed - - + + +

4. Short operative times - + + +

5. Short hospital stay - - + + +

6. Minimal Blood Loss - + + +

7. No Need for ICU Stay - + + +

8. Minimal Pain - + + +

9. High Patient Satisfaction - - - +

10. A Good "Exit Strategy" - + - +


RNY Band SG MGB

11. Decrease Hunger

Increase Satiety + - + +

12. Min Vomiting + + + +

13. No Int hernias - + + +

14. Min Heart/Lung - + + +

15. Low Failure Rate - - - +

16. Low Cost - - - +

17. Short Recovery - + + +

18. Return to Work - + + +

19. Low Risk of PE - + + +

20. Durable wt loss - - - +

C: CONSEQUENCES / RESULTS

RNY Band SG MGB

21. Low Risk of Ulcer - + + -

22. Malabsorption of fat + - - +

23. No Foreign Body + - + +

24. Verifiable Results

>10 yrs of Good Results - - - +

25. Bowel Obstruction - + + +

26. Sound surgical + - + +

27. Independent confirm - - - +

28. Healthy life - - - +

29. LEVEL I Evidence - - - +

30. Block Sweet Eater + - - +

CONCLUSIONS:

PROACT

• Pr: Choice of Obesity Surgery

• O: Objectives “Ideal” Weight Loss Surgery

• A: RNY, Band, Sleeve, MGB

• C: MGB meets almost all objectives/success criteria

• T: Fear of Gastric Cancer Not Supported by the Data

• Rational Decision Making: Best Choice;

Mini-Gastric Bypass

WHY CRITICS ONLY CARE FOR MGB?

• Why do Critics only care about the

Mini-Gastric Bypass?

• 100,000’s of people already have and are living with

and are getting the Billroth II every day

• Why haven’t concerned bariatric surgeons stepped

forward to stop all general, trauma and oncologic

surgeons from performing this Billroth II surgery?





forward to start a fund to help suffering Billroth II

patients get needed conversions of their surgery

to Roux-en-Y?

• Why don’t they write letters to the editor calling for the

Billroth II to be declared a operation non-grata?





forward to national funding for lifetime endoscopic

screening of Billroth II patients to find dreaded gastric

cancers?

• It seems odd doesn’t it?

• There is a simple reason


• There is a simple reason

• The critics of the MGB do not do those things because

they are ridiculous

• Such actions are Not supported by the data

• The Billroth II and the MGB are both good operations

• Published data Does Not support the critics misreading

of the medical literature

CRITICS OF THE

MINI-GASTRIC BYPASS

SHOULD BE EMBARRASSED

Dr Rutledge; USA 001-702-714-0011 [email protected]

ARE YOU CONSIDERING THE MGB?

WARNING: THERE ARE “TRICKS AND TRAPS”

OFFER A SAFE AND SUCCESSFUL

MGB PROGRAM

• Please Call / Email: Anytime question or advice on any

clinical, technical or patient MGB question


• Personal Visit: Dr Rutledge Visiting Prof: Costa Rica, Turkey,

France, Austria & India, Upcoming visits Greece, Istanbul,

Czech Republic, Italy and Germany

• Please Use the Knowledge of Others Before You Start;

Experience; over 14 years, over 6,000 patients


UPCOMING “HANDS ON” MGB IN INDIA

“TRICKS AND TRAPS” TRAINING PROGRAM

• Didactic Sessions

Talk with the Leading World Experts

• Hands On Surgery (with approval)

Scrub in on cases

Assist and

Participate in MGB Surgery

• This Fall and Next Year

• Bija India, Dr Rutledge & Dr Kular


THE TIDE BEGINS TO TURN

TO THE MINI-GASTRIC BYPASS

• “Not too long ago, the bariatric community questioned the

role of the mini-gastric bypass and its appropriateness as a

durable operation for obesity.”

• The experience of Lee et al. with a large cohort suggests

some answers.”

• Michel M. Murr, M.D.

• “The Journal continues to commit to open, spirited, and

balanced discussions that are supported by data and

withstand the test of common sense.”

A CLARION CALL FOR BETTER

BARIATRIC SURGERY

• RNY and VBG FAIL to Lengthen Life!

• Bariatric Surgery; A History of Complications &

Failure

• We Need Better Bariatric Surgery

• We Simpler, Safer, More Powerful, More Durable

and Revisable and Reversible

• We Need the MGB

MGB, 9 YEARS LATER!

OUT PERFORMS RNY

• Stunning new results of the MGB:

• “Of the 1,322 patients, 23 (1.7%) had undergone

revision surgery during a follow-up of 9 years.”

• Excess weight loss at 5 years after MGB was 72.1%

• No patient had surgery for internal hernia

SURVEY: MGB OUT-PERFORMS

BAND & RNY

• Follow up survey of bariatric surgery results in 1,500 patients’ friends, family and acquaintances

• Patient Reported Success in Friends Family:

36% RNY, 24% Band and 93% MGB

EXAMPLE FEAR & DECISION MAKING

SBO VS. GASTRIC CANCER

• Which is more Deadly?

• Gastric Cancer or Small

Bowel Obstruction?

• Which is more

fearsome?

11+ RNY STUDIES INTERNAL HERNIA

BOWEL OBSTRUCTION

• 1 - 16% Internal Hernia /Small Bowel

Obstruction

• Follow Up 1-10 years (only 7% at 10 years)

• Note: Dead patients cannot return for follow up

• =15/18 patients, ReOp, failed closure USA=

DEATH AFTER

SMALL BOWEL OBSTRUCTION

• 877 patients who underwent 1,007 operations for SBO from 1961 to 1995

• Risk of bowel obstruction increases over time

• 52 Deaths 6% Death Rate

• Ann Surg. 2000 April; 231(4), Complications and Death After Surgical Treatment

of Small Bowel Obstruction A 35-Year Institutional Experience Fevang et.al., Department of Surgery, University Hospital, University of Bergen, Norway

FEAR AND DECISION MAKING



• Gastric Cancer or

Small Bowel

Obstruction?

• Which is more

fearsome?



• 1,000 RNYs, Estimate 20% SBO => 200 operations

for SBO in 5-10 years (? How many more for 20

years?)

FEAR?


• 1,000 RNYs, 20% SBO => 200 operations for SBO in

5-10 years (? How many for 20 years?)

• 6% Death Rate => 12 dead before the end of 10

years from SBO

FEAR?





years from SBO

• 1,000 MGBs After 20 years possibly increased risk

of cancer of 1 / 1,000

FEAR?





years from SBO

• 1,000 MGBs After 20 years possibly increased risk

of cancer of 1/1,000

• Deaths at 10 years from Gastric Cancer 0.0

FEAR?


• 1,000 RNYs, 20% SBO => 200 operations for SBO in 5-10 years (? How many for 20 years?)

• 6% Death Rate => 12 dead before the end of 10 years from SBO

• 1,000 MGBs After 20 years possibly increased risk of cancer of 1/1,000

• Death at 10 years from Gastric Cancer 0.0

• Death SBO 12/10 years, Deaths Gastric Cancer 10-20 years 0-1

WHICH DO YOU FEAR?


• 1,000 RNYs = 200 SBO operations

• Death from RNY SBO 12 deaths / 10 years

• 1,000 MGB’s 0-1 Gastric Cancer @ 20 yrs

• Deaths Gastric Cancer 10-20 years 0-1?




• Gastric Cancer or

Small Bowel

Obstruction?

• Which is more

fearsome?

FOLLOW UP EFFECT • Unbiased Population based studies => Poor Results of RNY

• Positive Results of RNY reported from RNY centers

• Suffer from “Follow Up Effect”

• Patient Returns to clinic doing well: Greeted Warmly with Great Joy

• Patient Returns to clinic doing poorly: Greeted with anger and

disapproval

• Successful pt => Good Follow Up / Failed pt tacitly sent away

• Now; Center reports excellent results; (30%) follow up

• Weight Regain, Band Erosion, Death

• Not Seen, Not Reported

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A STRUCTURED APPROACH TO DECISION MAKING: CHOOSING · PDF fileA STRUCTURED APPROACH TO DECISION MAKING: CHOOSING THE BEST WEIGHT LOSS SURGERY ... 11. Change in eating ... Risk of gastric