ABSTRACT
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.
Subject(s)
Bariatric Surgery/methods , Electric Stimulation Therapy/instrumentation , Obesity, Morbid/surgery , Weight Gain/physiology , Electric Stimulation Therapy/methods , Feedback, Physiological , Humans , Prospective Studies , Prosthesis Implantation , Stomach/surgeryABSTRACT
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.
Subject(s)
Electric Stimulation , Feeding Behavior/physiology , Obesity, Morbid , Weight Loss/physiology , Adult , Female , Humans , Male , Middle Aged , Obesity, Morbid/epidemiology , Obesity, Morbid/therapy , Prostheses and Implants , Retrospective StudiesABSTRACT
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.
Subject(s)
Hernia, Ventral/surgery , Herniorrhaphy/adverse effects , Seroma/epidemiology , Aged , Female , Herniorrhaphy/methods , Humans , Incidence , Laparoscopy , Male , Middle Aged , Prospective Studies , Risk Factors , Seroma/etiology , Treatment OutcomeSubject(s)
Fundoplication/adverse effects , Stomach Volvulus/surgery , Esophageal Perforation/etiology , Esophageal Perforation/therapy , Hernia, Hiatal/complications , Hernia, Hiatal/surgery , Humans , Male , Middle Aged , Postoperative Complications/therapy , Radiography, Thoracic , Stomach Volvulus/diagnostic imaging , Tomography, X-Ray Computed , UltrasonographySubject(s)
Colonic Neoplasms/complications , Gastrointestinal Hemorrhage/etiology , Lipoma/complications , Rectum , Aged , Colonic Neoplasms/diagnosis , Colonic Neoplasms/pathology , Colonic Neoplasms/surgery , Colonoscopy , Humans , Lipoma/diagnosis , Lipoma/pathology , Lipoma/surgery , Male , Ulcer/etiologySubject(s)
Humans , Male , Middle Aged , Colonic Neoplasms/complications , Colonic Neoplasms/diagnosis , Gastrointestinal Hemorrhage/etiology , Lipoma/complications , Lipoma/diagnosis , Rectum/pathology , Colonic Neoplasms/pathology , Colonic Neoplasms/surgery , Colonoscopy , Lipoma/pathology , Lipoma/surgeryABSTRACT
No disponible
Subject(s)
Humans , Female , Aged , Endometrial Stromal Tumors , Rectal Neoplasms , Endometrial Stromal Tumors/diagnosis , Endometrial Stromal Tumors/surgery , Rectal Neoplasms/diagnosis , Rectal Neoplasms/surgeryABSTRACT
No disponible
Subject(s)
Humans , Female , Middle Aged , Colonic Neoplasms/complications , Intestinal Obstruction/etiology , Intussusception/complications , Lipoma/complicationsABSTRACT
La sospecha clínica de tuberculosis peritoneal debe estar presenteen todo paciente con dolor abdominal de etiología desconocida;sobre todo si se acompaña de fiebre, ascitis y distensión abdominal.El acceso por vía laparoscópica a la cavidad abdominalde forma reglada contribuye de manera primordial al diagnósticotanto por la imagen macroscópica como para la toma de biopsia,que dará posteriormente la confirmación anatomopatológica ymicrobiológica. Ayudando a discriminar entre los posibles diagnósticosdiferenciales que acontecen con clínica similar. Otraspruebas diagnósticas analíticas deben ser tenidas en cuenta paraayudar tanto a la indicación de laparoscopia como de cara al diagnóstico,son tales como la ADA, gammagrafía con Galio-67 y Ca-125
The presence of peritoneal tuberculosis has to be clinically suspectedin all patients with abdominal pain of unknown etiology,particularly when it is accompanied by fever, ascites, and abdominaldistension. Access to the abdominal cavity using routine laparoscopyprovides essential information on the diagnosis, fromboth macroscopic images and biopsy sampling, which will laterprovide a pathological and microbiological confirmation. Thishelps discriminate between potential differential diagnoses thatmay include similar symptoms. Other laboratory tests have to beconsidered as diagnostic aids, as well as for the indication of laparoscopy,including ADA, and Gallium-67 or Ca-125 scans (AU)
Subject(s)
Humans , Female , Adult , Peritonitis, Tuberculous/diagnosis , Laparoscopy , Abdominal Pain/etiology , Ascites/etiology , Diagnosis, DifferentialABSTRACT
No disponible
Subject(s)
Humans , Male , Adult , Sarcoma, Ewing/pathology , Neuroectodermal Tumors, Primitive/pathology , Soft Tissue Neoplasms/pathology , Abdominal Pain/etiologyABSTRACT
No disponible
Subject(s)
Humans , Female , Aged , Cutaneous Fistula/diagnosis , Intestinal Fistula/diagnosis , Ileal Diseases/diagnosis , Hernia, Umbilical/complications , Intestinal Perforation/complicationsSubject(s)
Angiomatosis , Disseminated Intravascular Coagulation/complications , Gastrointestinal Hemorrhage/etiology , Klippel-Trenaunay-Weber Syndrome/complications , Mesentery , Peritoneal Diseases/complications , Adult , Angiography , Humans , Klippel-Trenaunay-Weber Syndrome/diagnostic imaging , MaleABSTRACT
No disponible
Subject(s)
Male , Middle Aged , Humans , Angiomatosis/complications , Gastrointestinal Hemorrhage/etiology , Klippel-Trenaunay-Weber Syndrome/complications , Mesenteric Arteries/physiopathologyABSTRACT
The presence of peritoneal tuberculosis has to be clinically suspected in all patients with abdominal pain of unknown etiology, particularly when it is accompanied by fever, ascites, and abdominal distension. Access to the abdominal cavity using routine laparoscopy provides essential information on the diagnosis, from both macroscopic images and biopsy sampling, which will later provide a pathological and microbiological confirmation. This helps discriminate between potential differential diagnoses that may include similar symptoms. Other laboratory tests have to be considered as diagnostic aids, as well as for the indication of laparoscopy, including ADA, and Gallium-67 or Ca-125 scans.
