Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24 Months.

BACKGROUND: Weight regain following bariatric surgery is not uncommon. Safe, effective weight loss treatment up to 1 year has been reported with the closed-loop gastric electrical stimulation (CLGES) system. Continuous recording of eating and activity behavior by onboard sensors is one of the novel features of this closed-loop electrical stimulation therapy, and may provide improved long-term weight maintenance by enhancing aftercare. METHODS: Four centers participating in a 12-month prospective multicenter randomized study monitored all implanted participants (n = 47) up to 24 months after laparoscopic implantation of a CLGES system. Weight loss, safety, quality of life (QOL), and cardiac risk factors were analyzed. RESULTS: Weight regain was limited in the 35 (74%) participants remaining enrolled at 24 months. Mean percent total body weight loss (%TBWL) changed by only 1.5% between 12 and 24 months, reported at 14.8% (95% CI 12.3 to 17.3) and 13.3% (95% CI 10.7 to 15.8), respectively. The only serious device-/procedure-related adverse events were two elective system replacements due to lead failure in the first 12 months, while improvements in QOL and cardiovascular risk factors were stable thru 24 months. CONCLUSION: During the 24 month follow-up, CLGES was shown to limit weight regain with strong safety outcomes, including no serious adverse events in the second year. We hypothesize that CLGES and objective sensor-based behavior data combined to produce behavior change. The study supports CLGES as a safe obesity treatment with potential for long-term health benefits. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01448785.

Post-implant Analysis of Epidemiologic and Eating Behavior Data Related to Weight Loss Effectiveness in Obese Patients Treated with Gastric Electrical Stimulation.

OBJECTIVE: To determine possible preoperative predictors for obtaining clinically meaningful weight loss with gastric electrical stimulation (GES) using the "Three-Factor Eating Questionnaire" (TFEQ) as well as epidemiological data. METHODS: Ninety-seven obese participants in a prospective multicenter randomized study conducted in nine European centers were implanted laparoscopically with the abiliti® closed-loop GES system (CLGES). Five clinical variables and three preoperative TFEQ factor scores (F1-cognitive-restraint, F2-disinhibition, and F3-hunger) were analyzed in order to determine predictors of weight loss success defined as excess weight loss (EWL) > 30% and failure defined as EWL < 20% at 12 months post-surgery. RESULTS: The mean 12-month %EWL with CLGES was 35.1 ± 19.7%, with a success rate of 52% and a failure rate of 19%. Significant predictors of success were body mass index (BMI) < 40 kg/m2 and age ≥ 50 years, increasing probability of success by 22 and 29%, respectively. A low F1-cognitive-restraint score was a significant predictor of failure (p = 0.004). The best predictive model for success included F1-cognitive-restraint, F2-disinhibition, BMI < 40, and age ≥ 50 (p = 0.002). CONCLUSION: This retrospective analysis has shown that age, preoperative BMI, and F1-cognitive-restraint and F2-disinhibition scores from a preoperatively administered TFEQ are predictive of weight loss outcomes with CLGES and may be used for patient selection. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01448785.

Retroprosthetic seroma after laparoscopic ventral hernia repair: incidence, risk factors and clinical significance.

BACKGROUND: The seroma generated between the abdominal viscera and the prosthesis (retroprosthetic seroma), after laparoscopic ventral hernia repair (LVHR) with the implant of an intraperitoneal mesh is an unknown entity with few references in the literature. Our objective is to analyze its incidence, clinical repercussions and course of retroprosthetic seroma during the first 3 months post-operation and the factors related to its appearance, such as the relationship to preprosthetic seroma, the size of the prosthesis and the patient BMI. MATERIALS AND METHODS: Prospective, descriptive study in patients undergoing LVHR using the double crown technique. After surgery, the patients had follow-ups on the seventh day and the first and third months post-operation with clinical examination and abdominal CT scan. The study endpoints were: incidence and volume of retroprosthetic seroma, clinical repercussions, relationship to body mass index (BMI), prosthesis size and the existence of preprosthetic seroma. RESULTS: Fifty patients underwent LVHR using the double crown technique and were included in the study. The incidence of retroprosthetic seroma during the 3-month follow-up was 46%, there being a progressive process of spontaneous reabsorption. In just one patient (2%) there were clinical repercussions as a result of the seroma. No statistically significant relationship was found with BMI and preprosthetic seroma. A statistical relationship was found between the size of the prosthesis and the risk of suffering retroprosthetic seroma in the third month post-operation (p = 0.048). CONCLUSIONS: Retroprosthetic seroma is an entity produced in 46% of patients undergoing LVHR with few clinical repercussions (2%). In most cases it develops in the first week post-operation and then undergoes a reabsorption process that is usually complete by the third month post-operation. The size of the prosthesis delays the reabsorption process.

[Wandering spleen torsion]. / Bazo ectópico torsionado.

The ectopic spleen characterizes for absence of its suspensory ligaments and a long pedicle that are predisposed to complicate it for a torsion with commitment of the venous drainage at first and arterial at a later time himself, producing increase of its volume and infarct. This anomalous situation, it can be had to a congenital malformation of the development of its suspensory elements and fall toward the inferior abdomen or else to an inferior growth of the mesodermic yolk of that this organ originates itself. The suitable treatment is the laparoscopic splenopexy, but when it exists infarction, it is no possible avoid the splenectomy.

Bazo ectópico torsionado / Wandering spleen torsion

El bazo ectópico se caracteriza por ausencia de sus ligamentos suspensorios y un pedículo largo, que le predisponen a complicarse por una torsión, con compromiso del drenaje venoso en un principio y posteriormente arterial, produciendo aumento de su volumen e infarto. Esta situación anómala puede ser debida a una malformación congénita del desarrollo de sus elementos suspensorios y caída hacia el abdomen inferior, o bien a un crecimiento inferior de la yema mesodérmica de la que se origina este órgano. El tratamiento idóneo es la esplenopexia vía laparoscópica, pero cuando existe infarto no podemos evitar la esplenectomía (AU)

The ectopic spleen characterizes for absence of its suspensory ligaments and a long pedicle that are predisposed to complicate it for a torsion with commitment of the venous drainage at first and arterial at a later time himself, producing increase of its volume and infarct. This anomalous situation, it can be had to a congenital malformation of the development of its suspensory elements and fall toward the inferior abdomen or else to an inferior growth of the mesodermic yolk of that this organ originates itself. The suitable treatment is the laparoscopic splenopexy, but when it exists infarction, it is no possible avoid the splenectomy (AU)