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C.S.T.O. Who Would Have Thought It? Banded Gastric Bypass Works! MAL Fobi MD FACS, FICS, FACN Medical Director Center for Surgical Treatment of Obesity.

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Presentation on theme: "C.S.T.O. Who Would Have Thought It? Banded Gastric Bypass Works! MAL Fobi MD FACS, FICS, FACN Medical Director Center for Surgical Treatment of Obesity."— Presentation transcript:

1 C.S.T.O. 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 C.S.T.O. Banded Gastric Bypass Disclosures President of Bariatec Corporation. A device Compny I had a Banded Gastric Bypass

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

4 Obesity: A World Epidemic

5 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. 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. EATING DIS. HORMONALIMBALANCE PSYCHO-LOGICALDIS. SOCIO- ECOMOMICS WILLPOWER GENETIC Obesity is a disease with a Genetic Predisposition

6 C.S.T.O. ECONOMIC MEDICAL SOCIAL PSYCHOLOGICAL Significant ramifications of obesity

7 C.S.T.O. 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. 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. NIH Consensus Statements 1991

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

9 C.S.T.O. INTESTINAL BYPASS

10 C.S.T.O. GASTRIC BYPASS

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

12 T

13 T

14 T

15 Evolution of the Gastric Bypass Evolution of the Gastric Bypass Linners Banded Gastric Bypass 1984

16 Evolution of the Gastric Bypass Evolution of the Gastric Bypass Salmons Banded Vertical Gastroplasty Distal RYGBP 1986

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

18 C.S.T.O. Banded Gastric Bypass

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

20 Howard, Obesity Surgery, 1995 VBG VS. GBP

21 C.S.T.O. Average PEWL (All Pts.) Banded Gastric Bypass Average PEWL (All Pts.) Banded Gastric Bypass Fobi Obes. Surg. 2005

22 C.S.T.O. Why the Banded Gastric Bypass 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 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

23 83,5(45-115) 61,5(27-109) Awad et al Obes. Surg Presented at IFSO_LAC Congress Cartagenia, Columbia, March 2011 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. % EWL Banded vs Non Banded Gastric Bypass

24 C.S.T.O. Banded Gastric Bypass vs. Non-Banded Gastric Bypass Banded Gastric Bypass vs. Non-Banded Gastric Bypass Dr. Lemmens IFSO Dehli 2012 Retrospective Review

25 C.S.T.O. 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) months %EWL months %EWL months %EWL Complications %(n) 20%(5) 35%.(7) % of patients achieving 50%EWL 85% 65% BGBP vs. GBP Fobi et al IFSO 2011 Hamburg Germany

26 C.S.T.O. 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) months %EWL months %EWL months %EWL months %EWL Complications %(n) 23.9 (11) 29.5 (13) % of patients achieving 50%EWL 63% 45% His conclusion: It appears the banded gastric bypass produces more weight loss in more patients Marc Bressler, SOARD, July/August 2007 Banded Gastric Bypass VS. Non Banded Gastric Bypass.

27 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 BGBP vs. GBP

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

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

30 C.S.T.O. 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): Avinoah E. obes surg 2006; 6: Banded Gastric Bypass

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

32 C.S.T.O. 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) 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) Banding the Pouch in GBP

33 C.S.T.O. 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 Banded Gastric Bypass

34 Fisher after an in depth review concluded thatLong-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 Why the Band in the Gastric Bypass Operation Why the Band in the Gastric Bypass Operation

35 C.S.T.O. (* P < 0.05). [OBrien P.E.:Systemic review of mdium term-weight loss after bariatric surgery.; Obesity Surgery:2006; 16; ] %EWL for standard RYGBP and its two hybrid forms of LL-RYGBP and Banded RYGBP

36 Banded Gastric Bypass

37 C.S.T.O. Reservoir size change with time Non-banded Roux-en-Y GBP

38 C.S.T.O. Non-banded Roux-en-Y GBP

39 C.S.T.O. Non-banded Roux-en-Y GBP

40 C.S.T.O. Reservoir size change with time Banded Roux-en-Y GBP

41 C.S.T.O. Banded Gastric Bypass

42 Ring Ba nded Gastric Bypass Stubbs, Obes Surg; 2005

43 C.S.T.O. Optimal Ring Size 6.5 cm 2.07cm Diameter 1.47cm functional diameter. 3-D Recon Image of Ring Banded Gastric Bypass Mohit Bhandari Indore, India 2012 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

44 C.S.T.O. Band erosion: - 0-7%. 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 Complications from Banding the Gastric Bypass Banded Gastric Bypass Banded Gastric Bypass

45 C.S.T.O. 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 Ring Autolock and Gastrostomy Site Marker Clinical Research Study Protocol IDE G 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:Sponsors Commitments Appendix 8:Investigators Qualifications and Responsibilities Appendix 9:Investigators Agreement Appendix 10:Investigators 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 GaBP Ring TM Device

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

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

49 C.S.T.O.

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

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

52 C.S.T.O. 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. 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. Symptoms of Band Erosion

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

54 Endoscopic Removal

55 C.S.T.O. Outlet Stenosis Requiring Dilatation GBP 1-16% BGBP 1-3% Outlet Stenosis Requiring Dilatation GBP 1-16% BGBP 1-3% Banded Gastric Bypass

56 C.S.T.O. Reactive Hypoglycemia: - Observed in patients with Band removal or band erosion. Fobi et al. Presentation at OSSICON, Treated with ring placement Kasper ZGraggen. Obes Surg, 2008 Reactive Hypoglycemia: - Observed in patients with Band removal or band erosion. Fobi et al. Presentation at OSSICON, Treated with ring placement Kasper ZGraggen. Obes Surg, 2008 Banded Gastric Bypass

57 C.S.T.O. 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 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 Banded Gastric Bypass

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

59 C.S.T.O. 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) 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) Banded Gastric Bypass Felipe De La Cruz, Handbook of Obesity Surgery, FD- Communications Inc 2010

60 C.S.T.O. Who would Have Thought It? Banded Gastric Bypass Works! Banded Gastric Bypass

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

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

63 C.S.T.O. Ring placement forces use of a small tubular pouch with a standard stoma


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