single-anastomosis duodeno ileal bypass (sadi) versus roux-en-y gastric bypass

Conditions: Obesity, Morbid

Summary: obesity is a major public health problem worldwide. bariatric surgery has proved to be the most effective treatment of morbid obesity in terms of weight reduction and remission of co-morbid conditions during long-term follow-up. nowadays, france is ranked 3rd in terms of bariatric surgeries performed per year. since the laparoscopic roux-en-y gastric bypass (rygb) was described in 1977, this restrictive and malabsorptive procedure has become a gold standard for morbid obesity with an average excess weight loss % (ewl%) of 72% at 2 years, and a strong metabolic effect, especially with regard to type 2 diabetes remission. nevertheless, failures are observed (up to 20%), particularly in super obese patients, which are then difficult to manage. in this population, biliopancreatic diversion with duodenal switch (bpd-ds) is indicated due to its stronger weight loss and metabolic effect, but is still little performed worldwide because of its higher morbidity, surgical complexity and risk of malnutrition. a novel technique combining the physiological advantages of pylorus preservation and the technical benefits of single-loop reconstruction was introduced in 2007 by sanchez-pernaute, who described the single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (sadi-s) as an evolution of the bpd-ds. with a 2.5-meter common channel, sadi-s seems to offer good results for the treatment of both morbid obesity and its metabolic complications, with an ewl% of up to 95% at 2 years and potentially less nutritional consequences. to date, there is only one spanish randomized trial comparing sadi-s to bpd-ds, whereas bpd-ds represents less than 1% of bariatric procedures in france and is only allowed in super obese patients. thus only preliminary data of poor scientific value exists. nevertheless, facing very encouraging short-term outcomes, there is a real need for a prospective trial comparing sadi-s to a standard bariatric procedure. the aim of the investigator's study is to assess weight loss efficiency and the morbi-mortality of the sadi-s in comparison to a standard (rygb), in order to validate this procedure among bariatric techniques hypothesis sadi-s is superior to the standard rygb for weight loss, increasing the ewl% by 10% (82% vs 72%, respectively) at 2 years.


Eligibility criteria:
inclusion criteria: * patient aged between 18 and 65 years old, * morbid obesity with bmi ≥40 kg/m2 or bmi ≥35 kg/m2 associated with one co-morbidity which will be improved by surgery (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis) * patient who has benefited from an upper gi endoscopy with biopsies to look for helicobacter pylori , within the 12 months before surgery, * patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for sadi-s or rygb as a primary surgery or after failure of sleeve gastrectomy (defined as insufficient weight loss at 18 months after surgery (ewl% \<50), or as weight regain (+ 20%)). * patient who understands and accepts the need for a long term follow-up, * patient who agrees to be included in the study and who signs the informed consent form, * patient affiliated with a healthcare insurance plan. exclusion criteria: * history of previous bariatric surgery, other than a sleeve gastrectomy, * presence of a severe and evolutive life threatening pathology, unrelated to obesity, * history of type 1 diabete, * history of chronic inflammatory bowel disease, * pregnancy or desire to be pregnant during the study, * presence of helicobacter pylori resistant to medical treatment, * presence of a unhealed gastro-duodenal ulcer or diagnosed less than 2 months previously, * mentally unbalanced patients, under supervision or guardianship, * patient who does not understand french/ is unable to give consent, * patient not affiliated to a french or european healthcare insurance, * patient who has already been included in a trial which has a conflict of interests with the present study

Keywords: obesity bariatric surgery single-anastomosis duodeno ileal bypass (sadi) roux-en-y gastric bypass