Abstract
Background and study aims This was a single-blind, single-center, prospective randomized controlled trial aimed at comparing the efficacy of three different suture patterns for endoscopic sleeve gastroplasty using Endomina (E-ESG).
Patients and methods The suture patterns aimed to modify gastric accommodation by increasing the fundus distention ability (Group A), to reduce gastric volume (Group B) or to interrupt gastric emptying (Group C). Patients were randomized 1:1:1 and underwent clinical follow-up, gastric emptying scintigraphy, and satiety tests at baseline and 6 and 12 months post-procedure. The primary outcome was total body weight loss (TBWL) and excess weight loss (EWL) at 12 months post-procedure. Secondary outcomes included the impact of the suture patterns on gastric emptying and satiety.
Results Overall, 48 patients (40 [83.3 %] female, aged 41.9 ± 9.5 years, body mass indexI 33.8 ± 2.7 kg/m2) were randomized (16 in each group). In the entire cohort, mean (95 % confidence interval [CI]) TBWL and EWL at the end of the follow-up were 10.11 % (7.1–13.12) and 42.56 (28.23–56.9), respectively. There was no difference among the three study groups in terms of TBWL (95 %CI) (9.13 % [2.16–16.11] vs. 11.29 % [5.79–16.80] vs. 9.96 % [4.58–15.35]; P = 0.589) and EWL (95 %CI) (34.54 % [6.09–62.99] vs. 44.75 % [23.63–65.88] vs. 46.94 % [16.72–77.15]; P = 0.888) at 12 months post-procedure. The three groups did not differ in terms of mean gastric emptying time or in terms of satiety tests at the end of the follow-up. No serious adverse events occurred.
Conclusions Three different suture patterns during E-ESG demonstrated comparable efficacy in terms of weight loss, with an overall EWL of > 25 % and TBWL of > 10 % at 12 months.
