Long-Term Complications of Open Mason's Vertical Banded Gastroplasty at a Single Tertiary Center and Literature Review.

Vertical banded gastroplasty (VBG), introduced by Mason in 1982, is now discarded because of important long-term complications and technical difficulties to do revisional surgery. We investigated the long-term complications of VBG in our center and compared it with the literature data. Patients who underwent an open VBG at the University Hospital of Nantes between October 1991 and May 2006 were included. We reviewed preoperative clinical data, long-term outcome in weight loss, complications, and revisional surgeries with a long follow-up. Sixty-three patients (52 women and 11 men) were included, with a mean age of 43 ± 10 years and a body mass index of 46.7 ± 8.3 kg/m². The mean follow-up was 8.2 ± 4.2 years. At the end of follow-up, the mean excess weight loss (EWL) was 29.8%. Long-term success (excess weight loss > 50%) of the procedure was observed in 25 patients (39.7%). A second intervention was performed in 15 patients (23.8%), and three needed a third redo procedure. Six patients (40%) had this new intervention for late complications, and nine (60%) for weight regain. Weight loss is satisfying in the long term although the rate of reintervention is high. Long-term complication can be severe, especially with gastric stenosis that could lead to esophageal cancer. A second reintervention could be technically demanding, especially by laparoscopy, and the patients should be referred to a specialized center.

Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial.

BACKGROUND: Closed-loop insulin delivery systems are expected to become a standard treatment for patients with type 1 diabetes. We aimed to assess whether the Diabeloop Generation 1 (DBLG1) hybrid closed-loop artificial pancreas system improved glucose control compared with sensor-assisted pump therapy. METHODS: In this multicentre, open-label, randomised, crossover trial, we recruited adults (aged ≥18 years) with at least a 2 year history of type 1 diabetes, who had been treated with external insulin pump therapy for at least 6 months, had glycated haemoglobin (HbA1c) of 10% or less (86 mmol/mol), and preserved hypoglycaemia awareness. After a 2-week run-in period, patients were randomly assigned (1:1) with a web-based system in randomly permuted blocks of two, to receive insulin via the hybrid closed-loop system (DBLG1; using a machine-learning-based algorithm) or sensor-assisted pump therapy over 12 weeks of free living, followed by an 8-week washout period and then the other intervention for 12 weeks. The primary outcome was the proportion of time that the sensor glucose concentration was within the target range (3·9-10·0 mmol/L) during the 12 week study period. Efficacy analyses were done in the modified intention-to-treat population, which included all randomly assigned patients who completed both 12 week treatment periods. Safety analyses were done in all patients who were exposed to either of the two treatments at least once during the study. This trial is registered with ClinicalTrials.gov, number NCT02987556. FINDINGS: Between March 3, 2017, and June 19, 2017, 71 patients were screened, and 68 eligible patients were randomly assigned to the DBLG1 group (n=33) or the sensor-assisted pump therapy group (n=35), of whom five dropped out in the washout period (n=1 pregnancy; n=4 withdrew consent). 63 patients completed both 12 week treatment periods and were included in the modified intention-to-treat analysis. The proportion of time that the glucose concentration was within the target range was significantly higher in the DBLG1 group (68·5% [SD 9·4] than the sensor-assisted pump group (59·4% [10·2]; mean difference 9·2% [95% CI 6·4 to 11·9]; p<0·0001). Five severe hypoglycaemic episodes occurred in the DBLG1 group and three episodes occurred in the sensor-assisted pump therapy group, which were associated with hardware malfunctions or human error. INTERPRETATION: The DBLG1 system improves glucose control compared with sensor-assisted insulin pumps. This finding supports the use of closed-loop technology combined with appropriate health care organisation in adults with type 1 diabetes. FUNDING: French Innovation Fund, Diabeloop.