Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial

Abstract

ObjectiveEndoscopic 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).DesignEligible 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.ResultsOf 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%.ConclusionsThis 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 numberNCT03255005.

Endoscopic Treatment of Obesity and Nutritional Aspects of Bariatric Endoscopy

“…In addition, the quality of life was significantly better in the Endomina group than in the control group (52.8% vs. 42.1%). No serious adverse events were recorded during the trial [40].…”

Current endoscopic closure techniques for the management of gastrointestinal perforations

“… 63 – 65 Other over the scope suturing devices, such as Endomina (Endo Tools Therapeutics, Brussels) have since come on the market, however has primarily used in endoscopic suture gastroplasty. 66 , 67 A retrospective, single-centre study, showed promising results of colonic closures with suturing devices. Of 21 patients with iatrogenic colonic perforations 5 (24%) were closed with TTSCs and 16 (76%) with an endoscopic suturing device.…”

Endobariatric procedures for obesity: clinical indications and available options

“…Although the sample size is small in this study, it showed that quality of life and weight loss improve dramatically when ESG with Endomina system is used along with lifestyle modifications. 82 …”

“…Although the sample size is small in this study, it showed that quality of life and weight loss improve dramatically when ESG with Endomina system is used along with lifestyle modifications. 82 In June 2019, a consensus meeting of 47 endoscopists experienced in ESG with 1828 procedures was held in Brazil. The published results of this study showed a TBWL of 18.2% in 1 year.…”