clinical audit of sleeve gastrectomy, rny & mgb to find safe and effective bariatric &...

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CLINICAL AUDIT January 2007 to March 2014 For Effective and Safe BARIATRIC & METABOLIC PROCEDURE Dr. G. S. Jammu MS, FAIS Director cum Chief Bariatric Surgeon JAMMU HOSPITAL, JALANDHAR (PUNJAB) INDIA Email : [email protected] www.jammuhospital.com

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Page 1: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

CLINICAL AUDITJanuary 2007 to March 2014

For Effective and SafeBARIATRIC & METABOLIC PROCEDURE

Dr. G. S. JammuMS, FAIS

Director cum Chief Bariatric Surgeon

JAMMU HOSPITAL, JALANDHAR (PUNJAB) INDIAEmail : [email protected] • www.jammuhospital.com

Page 2: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Disclosures

Dr. G. S. JammuMS, FAIS

Director cum Chief Bariatric Surgeon

No Disclosure

Page 3: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Introduction

Obesity is complex disease, its epidemic is increasing not only

in developed countries but also in developing countries like

India. Obesity leads to many diseases like T2D, hypertension,

sleep apnea and fatty liver disease.

Bray, G.A. 1999. “Nutrition and obesity: Prevention and treatment”, Journal of Nutrition

Metabolic Cardiovascular Disease 9: 21-32.

Page 4: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Introduction

In 2013, 13% people were obese world wide. India is the

third most obese country with figures as high as 30 million.

In India problem is associated with under nutrition and the

significant proportion of overweight and obese people now

coexist. (Popkin, 2002).

• Lancet Journal

• Popkin, 2002

Page 5: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Objectives

Primary

To formulate safe & effective surgical policy for bariatric and

metabolic procedures.

Secondary

To analyze the post operative complications developed in

respective procedures by comparing LSG, RNY and MGB in

bariatric surgery.

Page 6: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Material and Methods

Audit is based on retrospective study carried out at a single centre Jammu Hospital Jalandhar, Indiafrom Jan 2007 to March 2014

by a Medical Audit Committee

• Bariatric Surgeon• Physician• Anesthetist• Bariatric Counselor• Nutritionist

Page 7: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

A Inclusion Criteria for complication part :

All 1,107 cases (87 months period).

B Inclusion Criteria for EWL & resolution of comorbidities

part :

Cases with mean follow-up of 53.5 months (Max. 87

months and Min. 20 months)

Material and Methods

Page 8: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

A Data Collection (Complication Part)

------------------------------------------------------------------------------------------Sample size : 1107 cases------------------------------------------------------------------------------------------Female : 63.0% (697) Male : 37.0% (410)------------------------------------------------------------------------------------------Mean Age : 46.5 Years (18-72 Years) Mean BMI : 42 (30-72)------------------------------------------------------------------------------------------T2D : 48.6% (538) HTN : 47.7% (528) Dyslipidemia : 42.7% (473)------------------------------------------------------------------------------------------LSG : 339 (30.6%) RNY : 295 (26.5%) MGB : 473 (42.7%)------------------------------------------------------------------------------------------Mean Surgery Time (Mins.) :MGB : 57.5 (42-75) RNY : 160.5 (123-198) LSG : 60 (45-75)------------------------------------------------------------------------------------------

Page 9: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Comorbidities

T2D : 29.0% (118)HTN : 30.7% (125)Dyslipidemia : 28.5% (116)

B Data CollectionEWL & Resolution of Comorbidities

( Mean follow-up of 53.5 months)

Types of Surgeries

LSG : 97 (23.83%)RNY : 143 (35.13%)MGB : 167 (41.03%)

Total sample size : 407 cases

Page 10: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

1. Complicationsa. Life threatening Complicationsb. Non Life threatening Complications

2. BenefitsEWL & Resolution of Comorbidities

Observations

Page 11: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Prevalence of Iron, folate & Vitamin B12 deficiency anemia after laparoscopic Roux-en-y gastric bypass. Vargas-Rulz AG, Hernonlez Rivera G, Herrera MI, Obes Surgery 2008 Mar. 18 (3), 288-93

Nutritional Deficiencies following Bariatric Surgery: What Have We Learned? Richard D. Bloomberg, MD, FRCSC; Amy Fleishman, MS, RD, CDN; Jennifer E. Nalle, RN, MS, FNP; Daniel M. Herron, MD, FACS; Subhash Kini, MD, FRCS

After gastric bypass surgery : Managing medical & surgical disorder : Macronutrient & Micronutrient disorders. Bikram Bal, MD, Timothy R. Koch, MD, Frederick C Fineli, MD, JD, Michael G.Sars, MD. CME Released 5/11/2010.

Complication External Bleeding

Internal Bleeding

Leaks Pulmonary Embolism

& DVT

Respiratory Failure

Persistent vomiting

Anaemia Mortality HypoAlbumin-

emia

LSG 1.42 0.44 0.71 1.33 3.56 2.14

RNY 0.625 0.625 0.625 4.05 0.625

Standard RNY1.9

-----------DistalRNY14.0

MGB 1 0.5 4.52 13.1

ObservationsLife Threatening Complications

Page 12: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Complication External Bleeding

Internal Bleeding

Leaks Pulmonary Embolism

& DVT

Respiratory Failure

Persistent vomiting

Anaemia Mortality HypoAlbumin-

emia

LSG 1.42 0.44 0.71 1.33 3.56 2.14

RNY 0.625 0.625 0.625 4.05 0.625

Standard RNY1.9

-----------DistalRNY14.0

MGB 1 0.5 4.52 13.1

ObservationsLife Threatening Complications

Prevalence of Iron, folate & Vitamin B12 deficiency anemia after laparoscopic Roux-en-y gastric bypass. Vargas-Rulz AG, Hernonlez Rivera G, Herrera MI, Obes Surgery 2008 Mar. 18 (3), 288-93

Nutritional Deficiencies following Bariatric Surgery: What Have We Learned? Richard D. Bloomberg, MD, FRCSC; Amy Fleishman, MS, RD, CDN; Jennifer E. Nalle, RN, MS, FNP; Daniel M. Herron, MD, FACS; Subhash Kini, MD, FRCS

After gastric bypass surgery : Managing medical & surgical disorder : Macronutrient & Micronutrient disorders. Bikram Bal, MD, Timothy R. Koch, MD, Frederick C Fineli, MD, JD, Michael G.Sars, MD. CME Released 5/11/2010.

Page 13: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Hypoalbuminemia in MGB

The high incidence of hypoalbuminemia was noticed in longer bypass

more than 230 cm.

In all the cases in which length of bypass was 200 cm or less, the

incidence of hypalbuminemia was not seen.

Except in one patient who had 200 cm bypass and hypoalbuminemia

was 3.0 g/dl. This patient was suffering from diabetic nephropathy. To

control the falling albumin levels in this patient we had to pay special

attention on his nutrition part and it was seen once patient started having

protein rich diet his level improved.

Page 14: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Step 1 • Nutritional Supplementation• In patients with Albumin Level between 2.6-3.5 g/dl

Step 2 •Reversal of Bypass•In patients with persistant Albumin Levels below 2.5 g/dl with ankle oedema

Management ofHypoalbuminemia in MGB

Page 15: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Management ofHypoalbuminemia in MGB

1 case of hypoalbuminemia had to be reversed.

All other cases of mild hypoalbuminemia responded to good nutritional

supplementation in the form of high protein diet and did not require any

intervention.

Now in all our patients the length of bypass is 200 cm and no

hypoalbuminemia is found in these patients.

Page 16: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Management of Hypoalbuminemiain Distal RNY

Revision Surgery is difficult, long and cumbersome.

Reversal requires revision of two anastamosis.

Page 17: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Complication Nausea Dumping Internal Hernia

Constipation Hair Loss GERD Weight Regain

Less ofExcess

weight loss

Gall Stone Formation

LSG 8

2.23 8 9.82 14 13.39 4.46

RNY 4.29 2.73 2.34 2.73 8 1.56 8 6.25 7.03

MGB 7.81 5.93

1.87 10 0.625

8.75

Predictors of gallstone formation after bariatric surgery : a multivariate analysis of risk factor compassing gastric bypass, gastric banding & sleeve gastrectomy. LIVK, Pulido N, Fajnwaks P, Szomstein S, Rosenthal R, Sury Endasc. 2008 Dec 5.

Bile reflux after Roux-en-Y gastric bypass; an unrecognized cause of postoperative pain. Swartz DE, Modley E, Felix EL, Sury Obes, Retat DA. 2009 Jan-Feb; 5(1):27-30.

ObservationsNon-Life Threatening Complications

Page 18: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Complication Nausea Dumping Internal Hernia

Constipation Hair Loss GERD Weight Regain

Less ofExcess

weight loss

Gall Stone Formation

LSG 8

2.23 8 9.82 14 13.39 4.46

RNY 4.29 2.73 2.34 2.73 8 1.56 8 6.25 7.03

MGB 7.81 5.93

1.87 10 0.625

8.75

Predictors of gallstone formation after bariatric surgery : a multivariate analysis of risk factor compassing gastric bypass, gastric banding & sleeve gastrectomy. LIVK, Pulido N, Fajnwaks P, Szomstein S, Rosenthal R, Sury Endasc. 2008 Dec 5.

Bile reflux after Roux-en-Y gastric bypass; an unrecognized cause of postoperative pain. Swartz DE, Modley E, Felix EL, Sury Obes, Retat DA. 2009 Jan-Feb; 5(1):27-30.

ObservationsNon-Life Threatening Complications

Page 19: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

LSG RNY MGB

Excess Weight Loss 53.57 72.26 92.18

Dyslipidemia 55.80 75 93.43

T2D 59.37 76.17 94.37

Hypertension 45.98 72.65 84.06

EWL & Resolution of Comorbidities

Bariatric surgery and diabetes remission : sleeve gastrectomy or mini gastric bypass ? Marco Milone, Matteo Nicola Dario Di Minno, Maddalena Leongito, Paola Maietta, Paolo Bianco, Caterina Taffuri, Dario Gaudioso, Roberta Lupoli, Silvia Savastano, Francesco Milone, and Mario Musella J Gastroenterol. Oct 21, 2013; 19(39): 6590–6597.

The laparoscopic mini-gastric bypass: the Italian experience: outcomes from 974 consecutive cases in a multicenter review. Musella M1, Susa A, Greco F, De Luca M, Manno E, Di Stefano C, Milone M, Bonfanti R, Segato G, Antonino A, Piazza L. Surg. Endosc. 2014 Jan 28(1), 156-63

Page 20: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

LSG RNY MGB

Excess Weight Loss 53.57 72.26 92.18

Dyslipidemia 55.80 75 93.43

T2D 59.37 76.17 94.37

Hypertension 45.98 72.65 84.06

EWL & Resolution of Comorbidities

Bariatric surgery and diabetes remission : sleeve gastrectomy or mini gastric bypass ? Marco Milone, Matteo Nicola Dario Di Minno, Maddalena Leongito, Paola Maietta, Paolo Bianco, Caterina Taffuri, Dario Gaudioso, Roberta Lupoli, Silvia Savastano, Francesco Milone, and Mario Musella J Gastroenterol. Oct 21, 2013; 19(39): 6590–6597.

The laparoscopic mini-gastric bypass: the Italian experience: outcomes from 974 consecutive cases in a multicenter review. Musella M1, Susa A, Greco F, De Luca M, Manno E, Di Stefano C, Milone M, Bonfanti R, Segato G, Antonino A, Piazza L. Surg. Endosc. 2014 Jan 28(1), 156-63

Page 21: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Summary

Audit indicted that … Mortality rate was 2.14 % in cases with LSG and 0.625 % in RNY

and NIL in MGB.

Leaks were highest in LSG (1.42 %) followed by RNY (0.625 %) and NIL

in MGB.

Persistent vomiting was in LSG only.

Weight regain was 14 % in LSG and 8 % in RNY but Nil in MGB.

Hypoalbuminemia was minimal in LSG, 1.9% in Standard RNY, 14% in

Distal RNY and 13.1% in MGB.

Resolution of Comorbidities like Dyslipidemia, T2D, Hypertension,

Excess Weight Loss was maximum in MGB

Page 22: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Obesity surgery results depending on technique performed; Long term outcome. Grecia JA, Martinez M, Ella M, Agculella V, Royo P, Jimenez A, Bielsa MA, Arribas D, Obes Sury. 2008 Nov 12

Benefits Excess weight loss Mortality Weight regain Hypertension T2D resolved Dyslipidemia

LSG 53.57 2.14 14 45.98 59.37 55.80

RNY 72.26 0.625 8 72.65 76.17 75

MGB 92.18 0 0 84.06 94.37 93.43

So, Why MGB ?

Page 23: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Obesity surgery results depending on technique performed; Long term outcome. Grecia JA, Martinez M, Ella M, Agculella V, Royo P, Jimenez A, Bielsa MA, Arribas D, Obes Sury. 2008 Nov 12

Benefits Excess weight loss Mortality Weight regain Hypertension T2D resolved Dyslipidemia

LSG 53.57 2.14 14 45.98 59.37 55.80

RNY 72.26 0.625 8 72.65 76.17 75

MGB 92.18 0 0 84.06 94.37 93.43

So, Why MGB ?

Page 24: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

2007 2008 2009 2010 2011 2012 20130

50

100

150

200

250

LSG RNY MGB

Transition of bariatric proceduresat our Centre

Page 25: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Conclusions

• On the basis of audit we concluded that MGB which is a

combination of sleeve and bypass is technically more easy to

perform in minimum time period comparative to LSG and RNY.

• Above all mortality rate was zero in MGB.

• EWL and resolution of comorbidities was highly significant in

our audit which simply makes MGB the simplest and most

effective procedure.

Page 26: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure

Policy

On the basis of this audit we suggest MGB is the procedure of

choice in patients with morbid obesity, who are compliant in taking

their vitamins, calcium and iron supplements.

LSG maybe done in non-compliant patients and who are ready to

accept weight regain.

RNY and MGB both procedures act on the same principle of

restriction and malabsorption but MGB supersedes RNY in its

technique, efficacy, reversibility and revisibility.

Page 27: Clinical Audit of Sleeve Gastrectomy, RNY & MGB to find safe and effective Bariatric & Metabolic Procedure