Abstract

Abstract Aims The cost of POSE 2.0 is very high, being one of the limitations of the accessibility of this procedure. The Endoscopic Sleeve Megaplication (ESM) procedure involves a novel pattern of full-thickness gastric body plications to shorten and narrow the stomach using the IOP platform (USGI Medical, San Clemente, CA) and durable suture anchor pairs g-Cath and two g-Lix simultaneously to achieve larger folds, reducing the number of sutures per procedure. Our prospective trial examined the safety and durability of ESM in adults with obesity grade I and II. Methods Adults suffering obesity underwent ESM in our centre. A single line of double plications in the greater curvature from incisura till 3-4 cm from gastro-oesophageal junction, single plications were placed in distal body anterior and posterior walls to close the diameter of the distal body under 10 mm. Primary outcomes were safety, durability of plications at 3-, 6-, 12- and 24-month follow-up and the cost effectiveness of the technique. Safety will be determined by the incidence of any serious adverse events reported either by the subject or observed by the investigator, relating to the procedure either peri-procedurally or in the follow-up period. All adverse events will be documented. Secondary outcomes were total body weight loss (%TBWL), proportion of patients achieving > 5% TBWL at 12 months and reduction of the cost of the procedure compared to standard POSE 2.0 technique, based on the average number of plications placed. Results 13 patients (7F, age 45 ± 9.9 years) underwent ESM between February 2022 to September 2022. Baseline BMI was 37.2 ± 3.1 kg/m2. Technical success was 100%. An average of 10 ± 2 suture anchor pairs were placed in each case. At six months, patients (n=13) achieved a 16.1 ± 3.9 % total weight loss (%TWL), with 84,61 % achieving more than 10 % TWL. Blood test results, state that insulin resistance and liver enzymes improved. No serious adverse events were reported. The reduction of an average of 8 plications compared to the standard POSE 2.0 pattern brings a significant reduction of the cost of the procedure. Conclusions ESM procedure happens to be effective for treating obesity and its related comorbidities. It is a safe, durable and a cost-effective procedure however, it is necessary to complete a long-term follow-up and carry out studies with larger samples to proclaim those benefits.

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