RESUMO
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).
Assuntos
Cirurgia Bariátrica/efeitos adversos , Balão Gástrico , Obesidade Mórbida/cirurgia , Complicações Pós-Operatórias/prevenção & controle , Cuidados Pré-Operatórios/instrumentação , Adulto , Cirurgia Bariátrica/métodos , Feminino , Gastrectomia/efeitos adversos , Derivação Gástrica/efeitos adversos , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Morbidade , Complicações Pós-Operatórias/etiologia , Período Pós-Operatório , Cuidados Pré-Operatórios/métodos , Estudos Prospectivos , Resultado do Tratamento , Redução de PesoRESUMO
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 (9.4â%) developed a complication such as intragastric migration of the band. Weight gain and pain were the main symptoms in 11 patients (92â%), and the mean time to the development of symptoms was 51.3 months. A single endoscopic treatment was successful in 7 of 9 patients (78â%). 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.