Introduction
Obesity awareness has recently increased following its pandemic evolution. Besides nutritional and lifestyle modifications and pharmacological therapy, many other therapeutic strategies have been evaluated, with fluid-filled intragastric balloon (FF-IB) being the most prevalent. There is still no consensus around which is the best filling volume for FF-IB, that is usually filled according to the physician’s expertise, with the purpose to tailor the filling on patient’s BMI and stomach shape. This study aimed to find out any differences in terms of outcomes of different FF-IB’s filling volume.
Aims & Methods
This was a single-center, observational prospective study of obese patients undergoing FF-IB (Medsil, Orbera) for 6 months, with a random filling volume of 500, 600, or 700 ml of saline and Methylene Blue (fig.1). The outcomes were evaluation of early post-procedural complications (pain, nausea and/or vomiting in the first 24 hours), percentage of early removal for intolerance, percentage of Total Body Weight Loss (TBWL%) and percentage of Excess Weight Loss (EWL%) at 6 months follow-up, quality of Life (QoL, measured by EQ-5D test) at 1, 3, and 6 months follow-up and modifications of blood tests and blood pressure at 6 months.
Results
Between July 2020 and May 2023, 180 obese patients (41.7±9.02 kg/m2, 46.2±14 years, 70% female, 53% obesity class III, Fatty Liver Disease as the main comorbidity; other baseline characteristics in table 1) underwent a FF-IB placement, that was removed after 180±12 days. Pain was the most frequent complication in the first 24 hours, being encountered in 77.5 % of patients, while nausea and/or vomiting were detected in 50.7 % of cases; no differences were observed among the three groups with different filling volume (pain p=0.180, nausea p=0.718, and vomiting p=0.480). Early removal was detected at a mean time of 75±43 days in 19 patients (10.6 %), with no differences among the 3 groups (p=0.870). At 6 months follow-up the mean TBWL% was 14.6±7.14, EWL% was 30.8±23.30, with no differences among the three groups (p=0.882 and p=0.733, respectively). QoL at 1, 3, and 6 months follow-up significantly improved from the baseline in each time frame (p<0.001) and this improvement was the same among the three groups (p=0.819, p=0.822, p=0.849). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and HbA1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after FF-IB placement (P<0.05), and no differences among the three groups of filling volume were detected.
Conclusion
An IB’s filling volume of 500, 600, or 700 ml seems to give the same outcomes in terms of post- procedural complications, percentage of early removal, TBWL%, EWL%, QoL, and improvement of blood tests and blood pressure, regardless of the baseline characteristics of patients.
Disclosure
The following authors have completed their 2024 DDW disclosure: Salvatore Vadalà di Prampero: Disclosure completed | Ica Bassu: No Answer. | Valentina Cosseddu: No Answer. | Alessandro Zuddas: No Answer. | Federica Di Maio: No Answer. | Paola Bazzu: No Answer. | Jessica Formichetti: No Answer. | Chiara Rocchi: No Answer. | Marco Massidda: No Answer. | Simona Masia: No Answer. | Giacomo Faleschini: No Answer. | Nikola Panic: No Answer. | Gabriella Manzoni: No Answer. | Guido Costamagna: No Answer. | Milutin Bulajic: No Answer.