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1.
Surg Obes Relat Dis ; 15(8): 1348-1354, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31302000

RESUMO

BACKGROUND: The AspireAssist is the first Food and Drug Administration-approved endoluminal device indicated for treatment of class II and III obesity. OBJECTIVES: We earlier reported 1-year results of the PATHWAY study. Here, we report 4-year outcomes. SETTING: United States-based, 10-center, randomized controlled trial involving 171 participants with the treatment arm receiving Aspiration Therapy (AT) plus Lifestyle Therapy and the control arm receiving Lifestyle Therapy (2:1 randomization). METHODS: AT participants were permitted to continue in the study for an additional year up to a maximum of 5 years providing they maintained at least 10% total weight loss (TWL) from baseline at each year end. For AT participants who continued the study, 5 medical monitoring visits were provided at weeks 60, 68, 76, 90, and 104 and thereafter once every 13 weeks up to week 260. Exclusion criteria were a history of eating disorder or evidence of eating disorder on a validated questionnaire. Follow-up weight, quality of life, and co-morbidities were compared with the baseline levels. In addition, rates of serious adverse event, persistent fistula, withdrawal, and A-tube replacement were reported. All analyses were performed using a per-protocol analysis. RESULTS: Of the 82 AT participants who completed 1 year, 58 continued to this phase of the trial. Mean baseline body mass index of these 58 patients was 41.6 ± 4.5 kg/m2. At the end of first year (at the beginning of the follow-up study), these 58 patients had a body mass index of 34.1 ± 5.4 kg/m2 and had achieved an 18.3 ± 8.0% TWL. On a per protocol basis, patients experienced 14.2%, 15.3%, 16.6%, and 18.7% TWL at 1, 2, 3, and 4 years, respectively (P < .01 for all). Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal. Improvements in quality of life scores and select cardiometabolic parameters were also maintained through 4 years. There were 2 serious adverse events reported in the second through fourth years, both of which resolved with removal or replacement of the A tube. Two persistent fistulas required surgical repair, representing approximately 2% of all tube removals. There were no clinically significant metabolic or electrolytes disorders observed, nor any evidence for development of any eating disorders. CONCLUSIONS: The results of this midterm study have shown that AT is a safe, effective, and durable weight loss alternative for people with class II and III obesity and who are willing to commit to using the therapy and adhere to adjustments in eating behavior.


Assuntos
Cirurgia Bariátrica , Drenagem , Gastrostomia , Obesidade Mórbida/terapia , Adulto , Cirurgia Bariátrica/efeitos adversos , Cirurgia Bariátrica/métodos , Cirurgia Bariátrica/estatística & dados numéricos , Índice de Massa Corporal , Drenagem/efeitos adversos , Drenagem/métodos , Drenagem/estatística & dados numéricos , Endoscopia Gastrointestinal , Gastrostomia/efeitos adversos , Gastrostomia/métodos , Gastrostomia/estatística & dados numéricos , Humanos , Pessoa de Meia-Idade , Resultado do Tratamento , Redução de Peso
2.
Gastroenterol Nurs ; 25(1): 15-9, 2002.
Artigo em Inglês | MEDLINE | ID: mdl-11852826

RESUMO

It is estimated that more than 15 million Americans suffer daily from gastroesophageal reflux disease (GERD) (De Vault, 1995). The spectrum of symptoms for GERD ranges from simple heartburn and regurgitation to persistent esophageal tissue damage with subsequent development of serious complications. The frequent occurrence and intensity of GERD symptoms can severely impact a person's quality of life (Behar, 1990). Until recently, treatment options included a lifetime of drug therapy, disagreeable daily lifestyle changes, and the possibility of invasive surgery. In 2000, the Food and Drug Administration cleared a new endoscopic tool called the EndoCinch, a device that enables endoscopic endoluminal gastroplication as an outpatient procedure for the treatment of GERD. Endoscopic endoluminal gastroplication has been shown to be a safe and effective therapeutic outpatient procedure offering sustainable clinical benefits and cost savings to patients suffering with GERD (Patel, 2001; Raijman, 2001; Weiland, 2001). The purpose of this article is to present an overview of GERD with a particular focus on management of the disease using this new procedure.


Assuntos
Refluxo Gastroesofágico/enfermagem , Refluxo Gastroesofágico/cirurgia , Gastroscopia/métodos , Procedimentos Cirúrgicos Ambulatórios , Desenho de Equipamento , Feminino , Seguimentos , Refluxo Gastroesofágico/diagnóstico , Gastroscópios , Humanos , Masculino , Cuidados Pós-Operatórios/enfermagem , Índice de Gravidade de Doença , Técnicas de Sutura , Resultado do Tratamento
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