Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass. International, multi centre, open, prospective, randomized study

Transcription

1 Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass International, multi centre, open, prospective, randomized study Karcz W. Konrad Lemmens Luc Bukhari Walid Ribeiro Rui Nora Mario Szewczyk Tomasz Greve Jan W.M. Miller Karl Grüneberger Jodok Küsters Simon - Albert-Ludwigs University of Freiburg,, Freiburg, Germany - AZ Niklaas, Sint-Niklaas, Belgium - International Medical Center, Jeddah, Saudi Arabia - University Hospital Lisboa, Lisboa, Portugal - Hospital de Sao Sebastiao, Porto, Portugal - University Hospital, Lodz, Poland - University Hospital Maastricht, Maastricht, Netherlands - Hospital Hallein, Department of General Surgery, Hallein, Austria - Albert-Ludwigs University of Freiburg,, Freiburg, Germany - Albert-Ludwigs University of Freiburg,, Freiburg, Germany

2 START

3 OVERALL DESIGN GABY was designed as an international, multi center, open, prospective, randomized study to compare two methods of bariatric surgery: Banded versus conventional laparoscopic Roux-en-Y gastric bypass. At least 8 international high volume centres of excellence in bariatric surgery and at least 168 patients in total were enrolled into study.

4 AIM OF THE STUDY Aim of this novel study is to evaluate, if an additional restrictive GaBP Ring can avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive better postoperative weight loss and significantly improved long-term weight maintenance.

5 OPERATION TECHNIQUE AL = 150 cm BPL = 50 cm Vertical Gastric Pouch > 20 ml 6,5 cm RaBP Ring Conventional RYGB Banded RYGB

6 GaBP RING

7 CT - SCANS Conventional RYGB Banded RYGB

8 OVERALL DESIGN RANDOMISATION Randomisation was done by assigning patients to Group A laparoscopic conventional Roux-en-Y gastric bypass Group B - laparoscopic banded (GaBP Ring) Roux-en-Y gastric bypass

9 SELECTION CRITERIA PRIMARY DIAGNOSIS Morbid obesity requiring bariatric surgery INCLUSION CRITERIA Age years BMI 40 kg /m 2 to 50 kg/m 2 Eating habit: sweet eater and volume eater Signed informed consent Patients with one or two of the following comorbidities: Hypertension Diabetes mellitus Type 2 Hyperlipidemia Hyperuricemia Degenerative diseases of: Spine osteochondrosis, hip, knee, feet

10 PATIENTS ALL PATIENTS: 168 INCLUDED IN THE STUDY: 143 CRYGB: 60 BRYGB: 83

11 PRIMARY ENDPOINT The prospective study was designed to evaluate excess body weight loss measured as Body Mass Index (BMI) reduction after banded versus conventional gastric bypass (primary endpoint) after 2 and 5 years.

12 [kg] WEIGHT ,43 126, ,12 73,55 CRYGB before 2 Years after BRYGB

13 [kg/m2] BMI ,91 44, before 29,73 2 Years after 26,14 CRYGB BRYGB 0

14 [%] EWL , , Years after CRYGB BRYGB 10 0

15 [%] EBMIL , , Years after CRYGB BRYGB 0

16 SECONDARY ENDPOINTS Changes in Metabolic Syndrom Safety of operation techniques Comparing early and late postoperative complications Comparison of Adverse Incidents (AIs)

17 [mmhg] Metabolic Syndrom systolic pressure ,29 139,28 129,5 105, before 2 Years after CRYGB BRYGB 0

18 [mmhg] Metabolic Syndrom diastolic pressure ,97 84,78 82,01 70, before 2 Years after CRYGB BRYGB 10 0

19 [mg%] Metabolic Syndrom Glucose ,08 120,52 82,03 87,25 CRYGB before 2 Years after BRYGB 0

20 [%] Metabolic Syndrom HbA1c 7 6 6,49 6,22 5,51 5, CRYGB before 2 Years after BRYGB 0

21 [mg/dl] Metabolic Syndrom Triglycerids ,17 206,63 170, before 2 Years after 104,14 CRYGB BRYGB

22 [ng/ml] The only difference STRONG RESTRICTION Vit. D ,56 80,03 Compliant by Supplementation ,85 before 16,33 2 Years after CRYGB BRYGB 0

23 [ng/ml] The only difference STRONG RESTRICTION Ferritin , Compliant by Supplementation ,98 107,66 before 2 Years after 55,96 CRYGB BRYGB 0

24 COMPLICATION

25 The only difference STRONG RESTRICTION Lab. Tests After 2 Years CRYGB BRYGB Low Fe 2+ 9 (15%) 4 (4,8%) Low Ferritin 6 (10%) 4 (4,8%) Low D3 15 (25%) 9 (10,84%) Low B1 0 (0%) 1 (1,2%) Sec. Hyperparathyreoidismus 5 (8,3%) 1 (1,2%)

26 The only difference STRONG RESTRICTION RING COMPLICATIONS After 2 Years CRYGB BRYGB Ring Ruptur - 2 (2,41%) Gastritis 0 2 (2,41%) Oesophagitis 0 1(1,2%) Ring removal - 3 (3,61%) Recurrence emesis 2 (3,3%) 3 (3,61%)

27 The only difference STRONG RESTRICTION Cumulative all complications CRYGB - 14 Patients (23%) BRYGB - 16 Patients (19,27%)

28 PUBLICATION End of enrollment was clused in Dezember 2010 Presented Data state Juli 2012 The two years results will be published in April 2013

29 CONCLUSION Do not be afraid of the Ring Thank you