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

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.

Conditions

• Obesity, Morbid

Interventions

PROCEDURE

SADI-S

Laparoscopic SADI-S, recently described as an evolution of the BPD-DS, combining the physiological advantages of pylorus preservation and the technical benefits of single-loop reconstruction, associating a sleeve gastrectomy and a duodeno-ileal bypass at 2.5 meters from the ileo-caecal valve if BMI ≥ 50 kg/m² or at 3 meters if BMI \< 50

PROCEDURE

RYGB

The laparoscopic Roux-en-Y Gastric Bypass will consist of: * a small gastric pouch (about 30cc) * an antecolic alimentary limb * a gastro-jejunal anastomosis using a linear stapler * a 150cm long alimentary limb * a 50cm biliary limb * a latero-lateral jejuno-jejunal anastomosis * closure of the mesenteric defects

Sponsors & Collaborators

• Hospices Civils de Lyon

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-18

Primary Completion

2023-12-04

Completion

2023-12-04

Countries

• France

Study Locations