Single-anastomosis Duodeno Ileal Bypass (SADI) Versus Roux-en-Y Gastric Bypass — SADISLEEVE  

Obesity, Morbid Clinical Trial

Official title: Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Single-anastomosis Duodeno Ileal Bypass With Sleeve Gastrectomy (SADI-S) Versus Roux-en-Y Gastric Bypass (RYGB)

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Obesity, Morbid

• NCT number: NCT03610256
• Study type: Interventional
• Source: Hospices Civils de Lyon
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 18, 2018
• Completion date: December 2031