Safety, tolerability and efficacy of a novel self-use biodegradable device for management of obesity.

OBJECTIVE: Obesity is a major public health issue with significant impact on quality of life, morbidity and mortality rates. It is estimated that if the current trends continue, 18% of men and 21% of women worldwide will be obese by 2025. All the current therapies are not optimal due to limited efficacy or safety; thus, there is a need for additional devices for the treatment of obesity. This study aimed to examine the safety, tolerability, and efficacy of a biodegradable encapsulated Epitomee device for weight loss. The technology is based on absorbent pharmaceuticals polymers and bonding materials that self-expand in the stomach to create a pH-sensitive super absorbent gel structure for weight loss. METHODS: A prospective, 12-week twice daily use of the encapsulated device in patients with body mass index of 27-40 kg m-2. Efficacy endpoints were the percent total body weight loss (%TBWL), proportion of participants with 5% TBWL and changes in cardio-metabolic markers. Safety analysis included evaluation of adverse events, laboratory and endoscopic findings. RESULTS: Overall, 52 patients completed the study. TBWL per intension-to-treat analysis was 3.68 ± 3.07% (3.23 ± 2.69 kg) and 4.52 ± 2.97% (3.95 ± 2.57 kg) per protocol. No device serious adverse effects reported. The most common adverse events were headache (18.1%), viral infection (11.5%), abdominal discomfort (10.1%), bloating (7.9%), nausea and constipation (5% each) and flatulence (4.3%). Endoscopy in 26 patients revealed mild, asymptomatic gastric/duodenal erythema without erosions in five patients. CONCLUSIONS: Twelve weeks of Epitomee capsules treatment combined with lifestyle counselling resulted in 3.68-4.52% of TBWL. With continued research, the Epitomee capsules have considerable potential to become a non-invasive, safe and effective treatment option for weight loss.

[Prophylactics and treatment of pyo-inflammatory complications after appendectomy]. / Profilaktika i lechenie gnoino-vospalitel'nykh oslozhnenii posle appendéktomii.

The developed method of prophylactics and treatment of pyo-inflammatory complications in the wound after operation of appendectomy with the help of mid-frequency ultrasound with dioxidin as phonophoresis allows to make suppurations in the postoperative patients 5.15 times rarer and the number of pyo-inflammatory complications 6.68 times rarer. The time of healing the wounds was 1.2+/-0.3 days shorter and the duration of treatment of such patients in the hospital 1.8+/-0.8 days less.

Computer assisted physiologic monitoring and stability assessment in vascular surgical patients undergoing general anesthesia--preliminary data.

BACKGROUND: Physiologic monitors present an influx of numerical data that can be overwhelming to the clinician. We combined several parameters in an effort to reduce the amount of information that must be continuously monitored including oxyhemoglobin saturation by pulse oximetry, end-tidal CO2 concentration, arterial blood pressure, and heart rate into an integrated measure--the health stability magnitude (HSM). The HSM is computed for a predetermined basal period, the reference HSM (RHSM), and recalculated continuously for comparison with the baseline value. In this study we present the HSM concept and examine changes in the HSM during abdominal aortic aneurysm surgery. MATERIALS AND METHODS: After IRB approval, nine patients were studied. The anesthesiologist recorded all significant intra-operative events. Within a defined time interval, data were recorded and used to calculate a combined parameter, the HSM. The baseline or reference value of this index (RHSM) was calculated after the induction of anesthesia. Individual HSM values were repeatedly calculated for ten second periods after the RHSM value was established. A > 30% deviation of the HSM from the RHSM was considered significant. Deviations in the HSM were compared with events recorded by the anesthesiologist on a paper record and with the record from an electronic record-keeping system. The deviation observed between two consecutive HSMs, called dHSM, was plotted against HSM to construct a contour diagram of data from all patients to which individual cases could be compared. RESULTS: The plot showed that dHSM vs. HSM values were tightly clustered. The inner contour on the distribution plot contained 90% of values. Individual patient's time course, projected on this diagram, revealed deviations form "normal" physiology. Fifty-nine events led to > 30% deviations in the HSM; 27 were anticipated events and 32 were unanticipated. CONCLUSION: The correlation between HSM and dHSM depicts changes in multiple monitored parameters that can be viewed using a single graphical representation. Projection of individual cases on the contour diagram may help the clinician to distinguish relative intraoperative stability from important events. Data reduction in this manner may guide clinical decision-making in response to unanticipated or unrecognized events.