TY - JOUR T1 - Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial JF - Gut JO - Gut DO - 10.1136/gutjnl-2020-322026 SP - gutjnl-2020-322026 AU - Vincent Huberty AU - Ivo Boskoski AU - Vincenzo Bove AU - Pauline Van Ouytsel AU - Guido Costamagna AU - Marc A Barthet AU - Jacques Devière Y1 - 2020/10/28 UR - http://gut.bmj.com/content/early/2020/10/27/gutjnl-2020-322026.abstract N2 - Objective Endoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium).Design Eligible patients (body mass index 30–40 kg/m2) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG.Results Of the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%.Conclusions This study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment.Trial registration number NCT03255005. ER -