5Obesity is a disease with a Genetic Predisposition PSYCHO-LOGICALDIS.SOCIO-ECOMOMICSEATING DIS.HORMONALIMBALANCEWILLPOWERGENETICThe exact method of genetic translation is not known at this time. TheExpression of obesity varies with social, cultural, environmental, economicand psychological influences.
6Significant ramifications of obesity MEDICALPSYCHOLOGICALECONOMICSOCIAL
7NIH 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.
8Surgical Treatment and Management of Obesity Surgical Treatment is the only treatment that provides effective long-term controlGastric Bypass/Banded Gastric bypassGastroplasty/Sleeve GastrectomyGastric BandingBilio-pancreatic Diversion with or without a SwitchIntestinal Bypass
22Why 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 obeseCapella, 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 2012There are only six long term series reported with the non-banded gastric bypass with an average of 55 PEWL, except Sutter with 70+ PEWLPories, Sutter, Dinitz, Christou, Higa, and the Swedish study22
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
24Banded Gastric Bypass vs. Non-Banded Gastric Bypass Dr. LemmensIFSO Dehli2012RetrospectiveReview
25BGBP vs. GBPProspective comparative evaluation of the Laparoscopically banded gastricbypass vs. the Laparoscopically non-banded gastric bypass.Banded GBP Non-Banded GBP(n= 20) (n=20)BMIAge (years)6 months %EWL12 months %EWL36 months %EWLComplications %(n) %(5) %.(7)% of patients achieving 50%EWL % %Fobi et al IFSO 2011 Hamburg Germany25
26Banded Gastric Bypass VS. Non Banded Gastric Bypass. Prospective comparative evaluation of the Laparoscopically banded gastricbypass vs. the Laparoscopically non-banded gastric bypass in the super obese.Banded GBP Non-Banded GBP(n=46) (n=44)BMIAge (years)6 months %EWL12 months %EWL24 months %EWL38 months %EWLComplications %(n) (11) (13)% of patients achieving 50%EWL % %His conclusion: It appears the banded gastric bypass producesmore weight loss in more patientsMarc Bressler, SOARD, July/August 200726
27BGBP 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
28Banded Gastric Bypass vs. Non-Banded Gastric Bypass Karcz et al. GaBP Ring European multicenter clinical trials.IFSO, Dehli 2012
29BGBP vs. GBP Herrera, Mexico, SOARD 2009 Prospective Evaluation with two years follow-upShowed no difference
30Banded Gastric BypassPublished reports of band placement in failed gastric bypass document increased weight loss and waight loss maintenanceBressler M. Obes Surg 2005;15:Kyzer S. Obes Surg 2001;11:66-9Gobble RM. Surg Edosc. 2008;22:Heath D. Obes Surg 2009;19:Himpens Obes Surg 2001, 11(4):528-31Avinoah E. obes surg 2006; 6:213-1530
31Adjustable Band Placement for Revision of failed Gastric Bypass BresslerObes. 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 pouchdoes not stretch.”( E.Mason, Obesity Surgery 1994; 4:66-72)
33MacLean, J Am Coll Surg 97; 185:1-7 Banded Gastric BypassAt 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; 185:1-733
34Gastric Bypass Operation Why the Band in theGastric Bypass OperationFisher 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; ]
36Banded Gastric BypassWhy and how does banding the pouch make it more effective for weight loss and Weight loss maintenance?- Fobi,
37Non-banded Roux-en-Y GBP Reservoir sizechange with time
433-D Recon Image of Ring Banded Gastric Bypass French Catheter Size1 Fr. = 1/3 mm diameter34 Fr. = 1.13cm diameter40 Fr. = 1.33cm diameter60 Fr. = 2.0cm diameterRing or bandshould be loosearound the pouchat time of bandingOptimal Ring Size6.5 cm2.07cm Diameter1.47cm functionaldiameter.Mohit BhandariIndore, India 2012
44Banded Gastric Bypass Complications from Banding the Gastric Bypass Band erosion: %. Incident directly related totype of the device used, the diameter and size of the device and thepresence of contamination or infection.Ring sizes < 6.5cm cause more erosion and dysphagiawithout increase in effectiveness.Kinking or Slippage: %. Functional ObstructionTreated by endoscopic dilatation or laparoscopic re explorationSolid Food intolerance: %. Not disabling.Treated by dietary counseling.Occasional need for Ring removal
45Surgeons have used various devices to band the pouch Surgeon fashioned devicesMarlex MeshSilastic TubingEthibond SutureLinea Alba FasciaPorchine GraftBovine GraftCommercially prefabricated devicesGaBP Ring. (Designed for use with the gastric bypass and sleeve gastrectomy)IOC BandAMI BandMinimizer BandBioring
46GaBP RingTM DeviceGaBP Ring Autolock™ and Gastrostomy Site Marker Clinical Research Study ProtocolIDE G050231IPERSONNEL 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
47GaBP RingTM DeviceGaBP Ring™ is a prefabricated, sterilized ring designed to band the proximal pouch of the sleeve gastrectomy and gastric bypass operations.
48Incidence of Band Erosion (May 1992 – May 2002)Banded Gastric Bypass3,632 (100 %)Primary3007( %)Secondary405( %)Revision220( 6.06 %)Band Erosion57 ( 1.89 %)24 ( 5.92 %)10 ( 4.54%)Total Incidence of Band Erosion:91/ 3,632 (2.5 %)
50Banded Gastric Bypass vs. Non-Banded Gastric Bypass Dr. LemmensIFSO Dehli2012RetrospectiveReview
51Banded Gastric Bypass vs. Non-Banded Gastric Bypass Karcz et al. GaBP Ring European multicenter clinical trials.IFSO, Dehli 2012
52Symptoms of Band Erosion 1. Outlet Stenosis/vomiting/dysphagia2. Stomal Ulcer/ pain/bleeding/melana3. Pain, epigastric and or left shoulder4. UGI Bleeding5. Acute weight loss followed byweight regain.
53Treatment of Band Erosion 1 - Expectant treatment-spontaneous extrusion2 - Endoscopic removal3 - Surgical Removal with revision.Band replacement vs. addition ofmal absorption component
56Reactive Hypoglycemia: Banded Gastric BypassReactive Hypoglycemia:-Observed in patients with Band removal or band erosion.Fobi et al. Presentation at OSSICON, 2004-Treated with ring placementKasper Z’Graggen. Obes Surg, 2008
57Banded Gastric Bypass There is enough evidence that: CONCLUSION:There is enough evidence that:“The banding the Gastric Bypass tostandardize the restrictive effect:results in more weight lossresults in weight loss in more patients even the super obese andresults in better weight loss maintenance”57
58Banded Gastric Bypass There is evidence that banding the CONCLUSION:There is evidence that banding thegastric bypass also results in lessincidence of:outlet stenosis requiring dilatation,dumping syndromereactive hypoglycemia58
59Banded 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 isobserved.(erosion, slippage, obstruction, infection, and device coming apart)Felipe De La Cruz,Handbook of Obesity Surgery, FD- Communications Inc 2010
60Who would Have Thought It? Banded Gastric Bypass Works!
61Center for Surgical Treatment of Obesity www.bariatec.com Thank YouC.S.T.O.MerushiDankeschönGrazieObrigadoMerciGraciasCenter for Surgical Treatment of ObesityMAL Fobi MD FASMBS, FACS FICS, FACN.
62Banded Gastric BypassHand Sewn Gastro-jejunostomy distal to GaBP Ring
63Ring placement forces use of a small tubular pouch with a standard stoma