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Who Would Have Thought It? Banded Gastric Bypass Works!

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Presentation on theme: "Who Would Have Thought It? Banded Gastric Bypass Works!"— Presentation transcript:

1 Who Would Have Thought It? Banded Gastric Bypass Works!
MAL Fobi MD FACS, FICS, FACN Medical Director Center for Surgical Treatment of Obesity Long Beach CA, USA

2 Banded Gastric Bypass Disclosures
President of Bariatec Corporation. A device Compny I had a Banded Gastric Bypass

3 Why the Banded Gastric Bypass?
Obesity, particularly Morbid Obesity, is a life long disease that is recalcitrant to any treatment, even surgical treatment.

4 Obesity: A World Epidemic

5 Obesity is a disease with a Genetic Predisposition
PSYCHO- LOGICAL DIS. SOCIO-ECOMOMICS EATING DIS. HORMONAL IMBALANCE WILL POWER GENETIC The exact method of genetic translation is not known at this time. The Expression of obesity varies with social, cultural, environmental, economic and psychological influences.

6 Significant ramifications of obesity
MEDICAL PSYCHOLOGICAL ECONOMIC SOCIAL

7 NIH Consensus Statements 1991
Prolonged and sustained weight loss has not bee proven with drug therapy. * Published studies of medical approaches to treatment of obesity include few reports or indications of efficacy in person with clinically severe obesity. Evidence of long-term efficacy of behavior modification in persons with clinically severe obesity is lacking. VLDC's used under close medical supervision generally have not been successful for achieving permanent weight loss.

8 Surgical Treatment and Management of Obesity
Surgical Treatment is the only treatment that provides effective long-term control Gastric Bypass/Banded Gastric bypass Gastroplasty/Sleeve Gastrectomy Gastric Banding Bilio-pancreatic Diversion with or without a Switch Intestinal Bypass

9 INTESTINAL BYPASS

10 GASTRIC BYPASS

11 Mason Gastroplasty 1971 Simple operation??? As effective
Less morbidity Less mortality

12 T

13 T

14 T

15 Evolution of the Gastric Bypass Linner’s Banded Gastric Bypass 1984

16 Vertical Gastroplasty Distal RYGBP
Evolution of the Gastric Bypass Salmon’s Banded Vertical Gastroplasty Distal RYGBP 1986

17 Evolution of the Gastric Bypass Banded Gastric Bypass
Fobi Modification 1986

18 Banded Gastric Bypass

19 Howard, Obesity Surgery, 1995
VBG VS. GBP VS 3-4cm Howard, Obesity Surgery, 1995

20 Howard, Obesity Surgery, 1995
VBG VS. GBP Howard, Obesity Surgery, 1995

21 Average PEWL (All Pts.) Banded Gastric Bypass Fobi Obes. Surg. 2005

22 Why the Banded Gastric Bypass Historical and Experimental Data:
There are eight series with long term (6-14years) follow-up documenting 70+ PEWL and weight loss maintenance in more patients, even the old and super obese Capella, USA, AJS; Fobi, USA, SOARD; White, New Zealand, Obes Surg; Salinas, Venuzuela SOARD; D.Margo, Obes Surg; Mali, Obes Surg; Cruz, Obes Surg; and Awad, Obesity Surgery 2012 There are only six long term series reported with the non-banded gastric bypass with an average of 55 PEWL, except Sutter with 70+ PEWL Pories, Sutter, Dinitz, Christou, Higa, and the Swedish study 22

23 % EWL Banded vs Non Banded Gastric Bypass Awad et al Obes. Surg. 2012
83,5(45-115) There is a significative difference in %EWL at month. We followed the banded patients for 10 and 12 years and they maintaing the same %EWL. We do not know about the non banded because we started to do it latter. 61,5(27-109) There is a significative difference in %EWL at month. We followed the banded patients for 10 and 12 years and they maintained the same %EWL. Presented at IFSO_LAC Congress Cartagenia, Columbia, March 2011

24 Banded Gastric Bypass vs. Non-Banded Gastric Bypass
Dr. Lemmens IFSO Dehli 2012 Retrospective Review

25 BGBP vs. GBP Prospective comparative evaluation of the Laparoscopically banded gastric bypass vs. the Laparoscopically non-banded gastric bypass. Banded GBP Non-Banded GBP (n= 20) (n=20) BMI Age (years) 6 months %EWL 12 months %EWL 36 months %EWL Complications %(n) %(5) %.(7) % of patients achieving 50%EWL % % Fobi et al IFSO 2011 Hamburg Germany 25

26 Banded Gastric Bypass VS. Non Banded Gastric Bypass.
Prospective comparative evaluation of the Laparoscopically banded gastric bypass vs. the Laparoscopically non-banded gastric bypass in the super obese. Banded GBP Non-Banded GBP (n=46) (n=44) BMI Age (years) 6 months %EWL 12 months %EWL 24 months %EWL 38 months %EWL Complications %(n) (11) (13) % of patients achieving 50%EWL % % His conclusion: It appears the banded gastric bypass produces more weight loss in more patients Marc Bressler, SOARD, July/August 2007 26

27 BGBP vs. GBP Schauer and Associates at the Cleveland Clinic
Presented Prospective Evaluation with two year follow-up at IFSO Congress in Hamburg (2011) Showed more weight loss and maintenance with the BGBP

28 Banded Gastric Bypass vs. Non-Banded Gastric Bypass
Karcz et al. GaBP Ring European multicenter clinical trials. IFSO, Dehli 2012

29 BGBP vs. GBP Herrera, Mexico, SOARD 2009
Prospective Evaluation with two years follow-up Showed no difference

30 Banded Gastric Bypass Published reports of band placement in failed gastric bypass document increased weight loss and waight loss maintenance Bressler M. Obes Surg 2005;15: Kyzer S. Obes Surg 2001;11:66-9 Gobble RM. Surg Edosc. 2008;22: Heath D. Obes Surg 2009;19: Himpens Obes Surg 2001, 11(4):528-31 Avinoah E. obes surg 2006; 6:213-15 30

31 Adjustable Band Placement for Revision of failed Gastric Bypass
Bressler Obes. Surg. 2005

32 ( E.Mason, Obesity Surgery 1994; 4:66-72)
Banding the Pouch in GBP “Since Roux-en-Y Gastric Bypass is primarily a restriction operation, just as with VBG, it is important that the outlet of the pouch does not stretch.” ( E.Mason, Obesity Surgery 1994; 4:66-72)

33 MacLean, J Am Coll Surg 97; 185:1-7
Banded Gastric Bypass At this time, the most promising technique based on a large series is that described by Capella and Capella, the “Banded Gastric Bypass” MacLean, J Am Coll Surg 97; 185:1-7 33

34 Gastric Bypass Operation
Why the Band in the Gastric Bypass Operation Fisher after an in depth review concluded that “Long-term results suggest that a silastic ring encircling the stomach pouch proximal to the gastroenterostomy may improve the outcome following gastric bypass surgery, resulting in more weight loss by a greater number of patients sustained for a longer time” - Fisher BL, Barber AE, Eur J Gatroenterol Hepatol 1999; 11:93-97

35 %EWL for standard RYGBP and its two hybrid forms of LL-RYGBP and Banded RYGBP
[O’Brien P.E.:Systemic review of mdium term-weight loss after bariatric surgery.; Obesity Surgery:2006; 16; ]

36 Banded Gastric Bypass Why and how does banding the pouch make it more effective for weight loss and Weight loss maintenance? - Fobi,

37 Non-banded Roux-en-Y GBP
Reservoir size change with time

38 Non-banded Roux-en-Y GBP

39 Non-banded Roux-en-Y GBP

40 Banded Roux-en-Y GBP Reservoir size change with time

41 Banded Gastric Bypass

42 Ring Banded Gastric Bypass
Stubbs, Obes Surg; 2005

43 3-D Recon Image of Ring Banded Gastric Bypass
French Catheter Size 1 Fr. = 1/3 mm diameter 34 Fr. = 1.13cm diameter 40 Fr. = 1.33cm diameter 60 Fr. = 2.0cm diameter Ring or band should be loose around the pouch at time of banding Optimal Ring Size 6.5 cm 2.07cm Diameter 1.47cm functional diameter. Mohit Bhandari Indore, India 2012

44 Banded Gastric Bypass Complications from Banding the Gastric Bypass
Band erosion: %. Incident directly related to type of the device used, the diameter and size of the device and the presence of contamination or infection. Ring sizes < 6.5cm cause more erosion and dysphagia without increase in effectiveness. Kinking or Slippage: %. Functional Obstruction Treated by endoscopic dilatation or laparoscopic re exploration Solid Food intolerance: %. Not disabling. Treated by dietary counseling. Occasional need for Ring removal

45 Surgeons have used various devices to band the pouch
Surgeon fashioned devices Marlex Mesh Silastic Tubing Ethibond Suture Linea Alba Fascia Porchine Graft Bovine Graft Commercially prefabricated devices GaBP Ring. (Designed for use with the gastric bypass and sleeve gastrectomy) IOC Band AMI Band Minimizer Band Bioring

46 GaBP RingTM Device GaBP Ring Autolock™ and Gastrostomy Site Marker Clinical Research Study Protocol IDE G050231 IPERSONNEL IISTUDY SYNOPSIS IIICLINICAL TRIAL Introduction and Rationale Study Objective Effectiveness Endpoints Safety Endpoints Study Design Patient Population Exclusion Criteria Inclusion Criteria Device Characterization Intended Use and Description Study Methods Patient Entry and Pre-operative Evaluation Device Installation and Intra-operative Evaluation Post-operative Care Post-operative Evaluation Study Procedures Data Monitoring Data Reporting and Monitoring Procedures Adverse Reaction and Adverse Event Reporting Study Analysis Sample Sizes Statistical Methods Bibliography IVAPPENDICES Appendix 1:Consent to Act as a Human Research Subject Appendix 2:Device Design and Labeling Appendix 3:Prior Clinical Investigations Appendix 4:Surgical Procedure Appendix 5:Device Removal Indications and Procedures Appendix 6:Examination Procedures, Study Equipment and Techniques Appendix 7:Sponsor’s Commitments Appendix 8:Investigator’s Qualifications and Responsibilities Appendix 9:Investigator’s Agreement Appendix 10:Investigator’s Financial Disclosure Declaration Appendix 11:Declaration of Helsinki/Protection of Human Subjects/Belmont Report/Institutional Review Board Appendix 12: Physician Information Letter Appendix 13:Case Report Forms

47 GaBP RingTM Device GaBP Ring™ is a prefabricated, sterilized ring designed to band the proximal pouch of the sleeve gastrectomy and gastric bypass operations.

48 Incidence of Band Erosion
(May 1992 – May 2002) Banded Gastric Bypass 3,632 (100 %) Primary 3007 ( %) Secondary 405 ( %) Revision 220 ( 6.06 %) Band Erosion 57 ( 1.89 %) 24 ( 5.92 %) 10 ( 4.54%) Total Incidence of Band Erosion: 91/ 3,632 (2.5 %)

49

50 Banded Gastric Bypass vs. Non-Banded Gastric Bypass
Dr. Lemmens IFSO Dehli 2012 Retrospective Review

51 Banded Gastric Bypass vs. Non-Banded Gastric Bypass
Karcz et al. GaBP Ring European multicenter clinical trials. IFSO, Dehli 2012

52 Symptoms of Band Erosion
1. Outlet Stenosis/vomiting/dysphagia 2. Stomal Ulcer/ pain/bleeding/melana 3. Pain, epigastric and or left shoulder 4. UGI Bleeding 5. Acute weight loss followed by weight regain.

53 Treatment of Band Erosion
1 - Expectant treatment- spontaneous extrusion 2 - Endoscopic removal 3 - Surgical Removal with revision. Band replacement vs. addition of mal absorption component

54 Endoscopic Removal

55 Banded Gastric Bypass Outlet Stenosis Requiring Dilatation GBP 1-16%
BGBP %

56 Reactive Hypoglycemia:
Banded Gastric Bypass Reactive Hypoglycemia: -Observed in patients with Band removal or band erosion. Fobi et al. Presentation at OSSICON, 2004 -Treated with ring placement Kasper Z’Graggen. Obes Surg, 2008

57 Banded Gastric Bypass There is enough evidence that:
CONCLUSION: There is enough evidence that: “The banding the Gastric Bypass to standardize the restrictive effect: results in more weight loss results in weight loss in more patients even the super obese and results in better weight loss maintenance” 57

58 Banded Gastric Bypass There is evidence that banding the
CONCLUSION: There is evidence that banding the gastric bypass also results in less incidence of: outlet stenosis requiring dilatation, dumping syndrome reactive hypoglycemia 58

59 Banded Gastric Bypass BANDED GASTRIC BYPASS
Is an operation with weight loss outcome similar if not better than the BPD and the Duodenal Switch operations without the associated metabolic consequences and complications? 1-7% Incidence of Band related complication is observed. (erosion, slippage, obstruction, infection, and device coming apart) Felipe De La Cruz, Handbook of Obesity Surgery, FD- Communications Inc 2010

60 Who would Have Thought It? Banded Gastric Bypass Works!

61 Center for Surgical Treatment of Obesity www.bariatec.com
Thank You C.S.T.O. Merushi Dankeschön Grazie Obrigado Merci Gracias Center for Surgical Treatment of Obesity MAL Fobi MD FASMBS, FACS FICS, FACN.

62 Banded Gastric Bypass Hand Sewn Gastro-jejunostomy distal to GaBP Ring

63 Ring placement forces use of a small tubular pouch with a standard stoma


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