Preoperative intragastric balloon in morbid obesity is unable to decrease early postoperative morbidity of bariatric surgery (sleeve gastrectomy and gastric bypass): a clinical assay.

INTRODUCTION: There are few studies that investigate the usefulness of the preoperative intragastric balloon (IGB). This study will evaluate if pre-surgical weight loss with IGB reduces morbidity and mortality after surgery. METHOD: Prospective randomised study of patients with morbid obesity treated with gastric bypass or vertical gastrectomy, with two arms: the balloon arm (B-arm), where an IGB was inserted within the 6 months before surgery, and the control arm (C-arm). RESULTS: The study included 66 patients: 65.6% women, 69.6% with bypass. Age: 43 years (SD 10.2) B-arm and 42.6 years (SD 9.2) in the C-arm. We found 34.4% therapeutic failures in IGB. The mean body weight loss, %EWL and BMI reduction before surgery was 16.2 kg (SD 9.84) B-arm versus 4.7 (SD 8.70) in the C-arm, 23.6% versus 4.7% (p < 0.001) and 6.04 versus 1 (p < 0.001), respectively. The hospital stay was 7 days (p25-75: 5-8) B-arm and 7 days (p25-75: 5-9) in the C-arm (p = 0.937). Post-surgical morbidity with IGB was 25% versus 29.5% in the C-arm, p = 0.689. The number needed to treat (NNT) to prevent of post-surgical morbidity was 23 patients. The B-arm presented 54.5% moderate-severe post-surgical adverse events (12.5%) versus 82.6% in the C-arm (23.5%), p = 0.111. The cost of placing a balloon was more than 4000 Euros each. CONCLUSIONS: The preoperative balloon does not achieve a reduction in the post-surgical morbidity, nor does it reduce the hospital stay or rate of re-operations. The balloon achieves a higher weight loss result when compared to a diet programme, its added cost must also be given due consideration. TRAIL REGISTRY: This study has been registered on ClinicalTrials.gov with the Identifier: NCT01998243 (November 28, 2013).

Utilidad del balón intragástrico previo a cirugía bariátrica / Usefulness of an intra-gastric balloon before bariatric surgery

Introducción: existen pocos estudios que analicen la utilidad del balón intragástrico (BIG) preoperatorio para disminuir la morbilidad relacionada con la cirugía bariátrica. En este estudio evaluamos si el adelgazamiento prequirúrgico mediante BIG disminuye la morbimortalidad tras la cirugía de la obesidad mórbida. Material y métodos: estudio caso-control emparejado 1:1 por sexo, edad y cirugía bariátrica (bypass gástrico/gastrectomía vertical). Se incluyeron pacientes con obesidad mórbida candidatos a cirugía bariátrica, siendo los casos A reclutados de un ensayo clínico en marcha y los controles H, pacientes operados previo al inicio del ensayo. El adelgazamiento prequirúrgico en el grupo A fue mediante BIG vs. dieta exclusivamente en H. Resultados: se incluyen 58 pacientes: 65,5% mujeres, 69% bypass y 31% gastrectomía vertical. La edad fue de 42 años en el grupo A y 43 en el H. Encontramos un 34,5% de fracasos terapéuticos del BIG. ASA III: 24,1% en A vs. 58,6% en H (p = 0,012). La pérdida de peso medio corporal (PPCT) antes de cirugía fue de 16,2 kg (desviación estándar [DE] 9,75) en el grupo A frente a 1,2 kg (DE 6,4) en el grupo H, p < 0,0001. El porcentaje de exceso de pérdida de peso (EPP) antes de la cirugía fue del 23,5% (DE 11,6) en el grupo A vs. 2,4 (DE 8) en el grupo H (p < 0,0001), y el porcentaje de exceso de índice de masa corporal perdida (EPIMC) fue del 34,6% (DE 24) en el grupo A vs. 0,98% (DE 12,4) en el grupo H (p < 0,0001). La estancia hospitalaria fue de siete días en el A y ocho en el H (p = 0,285). El tratamiento con BIG fracasó en el 34,5% de los pacientes. La morbilidad del BIG fue del 17,2% (6,9% grave). La morbilidad relacionada con la cirugía bariátrica/BIG fue del 41% en ambos grupos (p = 0,687); la morbilidad quirúrgica moderadagrave en el grupo A fue del 20,3% (dos pacientes, 6,9% grave) y del 27,3% en el H (cinco pacientes, 17,2% grave), sin diferencias significativas. Un paciente falleció en el grupo H (3,44%). Conclusión: el BIG preoperatorio no consigue disminuir la morbilidad postquirúrgica de la cirugía bariátrica, y tampoco la estancia ni la tasa de reoperaciones, sin olvidar su coste, pese a que el BIG consigue mayor adelgazamiento que la dieta y el aumento de actividad física (AU)

Introduction: There are only few reports regarding the use of intragastric-balloons (IGB®) to achieve weight loss and subsequently decrease surgical complications. In this study, we try to assess whether presurgery weight loss using IGB decreases the postsurgical mortality after bariatric surgery. Methods: This is a prospective case-control study. We matched 1:1 by gender, age (± 10 y-o) and type of surgery (sleeve resection [LSG] or gastric bypass [LGBP]), matching cases (A) and controls (H, from a historic cohort). Morbidly obese patients with an indication for bariatric surgery were included in the study. Cases (A) were recruited from an ongoing clinical trial, and the controls (H) came from a historic cohort prior to the start of the clinic trial. The presurgical weight loss in group A was reached by IGB combined with diet, versus only diet in group H. Results: We included 58 patients, 65.5% women, 69% LGBP/31% LSG. The mean age of group A was 42 and 43.4 years old for group H. ASA III of 24.1% group A vs 58.6% group H, p = 0.012. The mean total weight loss (TWL) before surgery was greater in group A (16.2 kg, SD 9.75) than in group H (1.2 kg, SD 6.4), p < 0.0001. The % of EWL before surgery was 23.5 (SD 11.6) in group A vs 2.4 (SD 8) in group H, p < 0.001. Hospital stay was seven days for group A, and eight days for group H, p = 0.285. The rate of unsuccessful IGB treatment to accomplish the scheduled weight loss was 34.5%. The balloon morbidity was 17.2% (6.9% severe). All in all, morbidity (due to bariatric surgery and IGB) was 41% in both groups. Postsurgical morbidity moderate-severe was 20.3% in group A (6.9% severe) and 27.3% in group H (17.2% severe) without statistical significance. One patient died in group H (mortality rate, 3.44%). Conclusion: Preoperative IGB treatment in morbid obesity has not been found to be effective at decreasing postsurgical morbidity LSG and LGBP, despite the fact that it acheives a greater weight loss than diet and exercise (AU)

Usefulness of an intra-gastric balloon before bariatric surgery.

INTRODUCTION: There are only few reports regarding the use of intragastric-balloons (IGB®) to achieve weight loss and subsequently decrease surgical complications. In this study, we try to assess whether presurgery weight loss using IGB decreases the postsurgical mortality after bariatric surgery. METHODS: This is a prospective case-control study. We matched 1:1 by gender, age (± 10 y-o) and type of surgery (sleeve resection [LSG] or gastric bypass [LGBP]), matching cases (A) and controls (H, from a historic cohort). Morbidly obese patients with an indication for bariatric surgery were included in the study. Cases (A) were recruited from an ongoing clinical trial, and the controls (H) came from a historic cohort prior to the start of the clinic trial. The presurgical weight loss in group A was reached by IGB combined with diet, versus only diet in group H. RESULTS: We included 58 patients, 65.5% women, 69% LGBP/31% LSG. The mean age of group A was 42 and 43.4 years old for group H. ASA III of 24.1% group A vs 58.6% group H, p = 0.012. The mean total weight loss (TWL) before surgery was greater in group A (16.2 kg, SD 9.75) than in group H (1.2 kg, SD 6.4), p < 0.0001. The % of EWL before surgery was 23.5 (SD 11.6) in group A vs 2.4 (SD 8) in group H, p < 0.001. Hospital stay was seven days for group A, and eight days for group H, p = 0.285. The rate of unsuccessful IGB treatment to accomplish the scheduled weight loss was 34.5%. The balloon morbidity was 17.2% (6.9% severe). All in all, morbidity (due to bariatric surgery and IGB) was 41% in both groups. Postsurgical morbidity moderate-severe was 20.3% in group A (6.9% severe) and 27.3% in group H (17.2% severe) without statistical significance. One patient died in group H (mortality rate, 3.44%). CONCLUSION: Preoperative IGB treatment in morbid obesity has not been found to be effective at decreasing postsurgical morbidity LSG and LGBP, despite the fact that it acheives a greater weight loss than diet and exercise.

Endoscopic extraction of adjustable gastric bands after intragastric migration as a complication of bariatric surgery: technique and advice.

BACKGROUND: Surgery has been the method most widely used to manage the extraction of gastric bands with inclusion as a late complication of bariatric surgery; however, surgical extraction entails morbidity and limits future surgical procedures. The development of endoscopic techniques has provided an important means of improving the treatment of this complication, enabling minimally invasive and safe procedures that have a high success rate. METHODS: A retrospective analysis was conducted of patients who had laparoscopic gastric banding complicated by intragastric migration and were treated endoscopically. A technique already described for managing this complication was employed. An MTW Endoskopie Dormia basket for mechanical lithotripsy or a standard 0.0035-in guidewire was placed around the band, and an MTW Endoskopie emergency lithotripter was used to section it, after which the band was extracted with a standard polypectomy snare. Also analyzed were the initial symptoms of patients with this complication, the mean time from surgery to development of the event, the success rate of endoscopic treatment, and complications, Results: A total of 127 patients had undergone gastric banding surgery in our Bariatric Surgery Center; of these, 12 patients (9.4 %) developed a complication such as intragastric migration of the band. Weight gain and pain were the main symptoms in 11 patients (92 %), and the mean time to the development of symptoms was 51.3 months. A single endoscopic treatment was successful in 7 of 9 patients (78 %). Only 1 complication, involving ventilation during anesthesia, occurred; no other adverse events were recorded. CONCLUSIONS: The endoscopic extraction of bands with inclusion is feasible and can be performed easily and successfully. The procedure is available in all hospitals and has a low incidence of related complications, so that unnecessary surgical procedures can be avoided.

Adrenalectomy for solid tumor metastases: results of a multicenter European study.

BACKGROUND: We assessed the results of adrenalectomy for solid tumor metastases in 317 patients recruited from 30 European centers. METHODS: Patients with histologically proven adrenal metastatic disease and undergoing complete removal(s) of the affected gland(s) were eligible. RESULTS: Non-small cell lung cancer (NSCLC) was the most frequent tumor type followed by colorectal and renal cell carcinoma. Adrenal metastases were synchronous (≤6 months) in 73 (23%) patients and isolated in 213 (67%). The median disease-free interval was 18.5 months. Laparoscopic resection was used in 46% of patients. Surgery was limited to the adrenal gland in 73% of patients and R0 resection was achieved in 86% of cases. The median overall survival was 29 months (95% confidence interval, 24.69-33.30). The survival rates at 1, 2, 3, and 5 years were 80%, 61%, 42%, and 35%, respectively. Patients with renal cancer showed a median survival of 84 months, patients with NSCLC 26 months, and patients with colorectal cancer 29 months (P = .017). Differences in survival between metachronous and synchronous lesions were also significant (30 vs. 23 months; P = .038). CONCLUSION: Surgical removal of adrenal metastasis is associated with long-term survival in selected patients.