Open label, prospective, randomized controlled trial of an endoscopic duodenal-jejunal bypass sleeve versus low calorie diet for pre-operative weight loss in bariatric surgery
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The duodenal-jejunal bypass sleeve (DJBS) has been shown to achieve a completely endoscopic duodenal exclusion without the need for stapling. This report is the first randomized controlled trial for weight loss.
In a 12-week, prospective, randomized study, subjects received either a low fat diet and the DJBS or a low fat diet control (no device). Twenty-five patients were implanted with the device and 14 received the control. The groups were demographically similar. Both groups received counseling at baseline only, which consisted of a low calorie diet, and exercise/behavior modification advice. No additional counseling occurred in either group. Measurements included starting and monthly body weight and serum blood tests. The device group also had a plain abdominal film post implant, a monthly KUB and a 4-week post explant EGD.
Twenty device (80%) subjects maintained the DJBS without a significant adverse event for the 12-week duration. At 12 weeks, the mean excess weight loss was 22% and 5% for the device and control groups, respectively (p < 0.001). Five subjects (20%) were endoscopically explanted early secondary to upper GI (UGI) bleeding (n = 3), anchor migration (n = 1) and sleeve obstruction (n = 1). The UGI bleeding occurred at a mean of 13.8 days post implant. EGD was performed in each of these cases with no distinct bleeding source identified. No blood transfusion was required. The migration occurred on day 47 and manifested as abdominal pain. The subject with the sleeve obstruction presented with abdominal pain and vomiting on day 30. Eight subjects (40%) underwent the 4 week post explant EGD at which time mild degrees of residual duodenal inflammation was noted.
The DJBS achieves noninvasive duodenal exclusion and short term weight loss efficacy. Longer term randomized controlled sham trials for weight loss and treatment of T2DM are underway.
- Namba RS, Paxton L, Fithian DC, Stone ML (2005) Obesity and perioperative morbidity in total hip and total knee arthroplasty patients. J Arthroplasty 20(7 Suppl 3):46–50 CrossRef
- Gillespie GN, Porteous AJ (2007) Obesity and knee arthroplasty. Knee 14:81–86 (Epub 22 December 2006) CrossRef
- Modlin CS, Flechner SM, Goormastic M, Goldfarb DA, Papajcik D, Mastroianni B, Novick AC (1997) Should obese patients lose weight before receiving a kidney transplant? Transplantation 64:599–604 CrossRef
- Tsereteli Z, Pryor BA, Heniford BT, Park A, Voeller G, Ramshaw BJ (2007) Laparoscopic ventral hernia repair (LVHR) in morbidly obese patients. Hernia, Epub ahead of print
- Raftopoulos I, Courcoulas AP (2007) Outcome of laparoscopic ventral hernia repair in morbidly obese patients with a body mass index exceeding 35 kg/m2. Surg Endosc 21:2293–2297 (Epub 24 May 2007) CrossRef
- Alvarado R, Alami RS, Hsu G, Safadi BY, Sanchez BR, Morton JM, Curet MJ (2005) The impact of preoperative weight loss in patients undergoing laparoscopic Roux-en-Y gastric bypass. Obes Surg 15:1282–1286 CrossRef
- Alami RS, Morton JM, Schuster R, Lie J, Sanchez BR, Peters A, Curet MJ (2007) Is there a benefit to preoperative weight loss in gastric bypass patients? A prospective randomized trial. Surg Obes Relat Dis 3:141–145 discussion 145–146 (Epub 27 February 2007) CrossRef
- Liu RC, Sabnis AA, Forsyth C, Chand B (2005) The effects of acute preoperative weight loss on laparoscopic Roux-en-Y gastric bypass. Obes Surg 15:1396–1402 CrossRef
- Still CD, Benotti P, Wood GC, Gerhard GS, Petrick A, Reed M, Strodel W (2007) Outcomes of preoperative weight loss in high-risk patients undergoing gastric bypass surgery. Arch Surg 142:994–998 (discussion 999) CrossRef
- National Institutes of Health clinical guidelines on the identification, evaluation and treatment of overweight and obesity in adults. NIH publication 98-4083, September 1998
- Rodriguez-Grunert L, Galvao Neto MP, Alamo M, Ramos AC, Baez PB, Tarnoff M (2008) First human experience with endoscopically delivered and retrieved duodenal-jejunal bypass sleeve. Surg Obes Relat Dis 4:55–59 CrossRef
- Moo TA, Rubino F (2008) Gastrointestinal surgery as treatment for type 2 diabetes. Curr Opin Endocrinol Diabetes Obes 15:153–158
- Open label, prospective, randomized controlled trial of an endoscopic duodenal-jejunal bypass sleeve versus low calorie diet for pre-operative weight loss in bariatric surgery
Volume 23, Issue 3 , pp 650-656
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- Duodenal bypass
- Preoperative weight loss
- Industry Sectors
- Author Affiliations
- 1. Department of Surgery, Tufts–New England Medical Center, Boston, MA, USA
- 2. Centro de Cirugía de la Obesidad, Hospital Dipreca, Santiago de Chile, Chile
- 3. Departamento de Cirugía Digestiva, Pontificia Universidad Católica de Chile, Facultad de Medicina, Santiago, Chile
- 4. Department of Bariatric Surgery, Gastro Obeso Center, Sao Paulo, Brazil