This section describes efficacy outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 In a case series of 100 patients with morbid obesity or metabolic disease treated with single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI‑S), the mean excess weight loss (EWL calculated from an ideal body mass index [BMI] of 25 kg/m2) was 95% at 12 months. This was maintained for maximum of 48 months of follow-up, with no significant differences between those who had SADI‑S 200 cm from the ileocecal valve and those with SADI‑S 250 cm. In a case series of 97 patients with obesity and type 2 diabetes treated with SADI‑S, EWL was 92% (74/80) at 2‑year follow-up and 98% (425/32) at 5‑year follow-up. Six percent (6/97) of patients failed to reach 50% EWL. In a case series of 123 patients with morbid obesity treated with stomach intestinal pylorus sparing (SIPS) procedure, EWL was 72% (64/102) at 1‑year follow-up.
4.2 In the case series of 97 patients, overall weight loss was 39% at 2‑year follow-up and 38% at 5‑year follow-up. In the case series of 123 patients, overall weight loss was 39% and patients had an average change in BMI of 19 kg/m2 at 1‑year follow-up.
4.3 In the case series of 100 patients, the mean glycaemia level decreased from 178.2 mg/dl at baseline to 94.2 mg/dl at 1‑year follow-up and to 79.6 mg/dl at 4‑year follow-up. The mean glycated haemoglobin (HbA1c) level decreased from 7.9% at baseline to 5.3% at 1‑year follow-up and to 5.0% at 4‑year follow-up. In the case series of 97 patients, the mean glycaemia level reduced from 167.6 mg/dl at baseline to 93.0 mg/dl at 1‑year follow-up and to 101.6 mg/dl at 5‑year follow-up. The mean HbA1c level reduced from 7.6% at baseline to 5.1% at 1‑year follow-up and to 5.5% at 5‑year follow-up.
4.4 In the case series of 97 patients, the overall diabetes remission rate (defined as HbA1c below 6% without antidiabetic medication for more than 1‑year) was 77% at 2 years and 52% at 5 years. Remission rates were higher for those having oral therapy (n=14) than for those having insulin therapy (n=40) (97% versus 54% at 2 years; 75% versus 38% at 5 years).
4.5 In the case series of 97 patients, type 2 diabetes recurred in 8% (4/97) of patients within 5 years (308 patient-years follow-up).
4.6 In the case series of 123 patients, mean values for the nutritional data (Vitamin A, B1, B12, D and albumin) were at normal levels at 1‑year follow-up.
4.7 The specialist advisers listed key efficacy outcomes as weight loss, remission of type 2 diabetes, resolution of obesity-related comorbidities and improvement in quality of life.