Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study.
Surg Obes Relat Dis
; 17(5): 956-962, 2021 May.
Article
en En
| MEDLINE
| ID: mdl-33674199
ABSTRACT
BACKGROUND:
The long-term safety results of the REALIZE (Ethicon Endo-Surgery, Inc., Cincinnati, OH) adjustable gastric band collected in this prospective, multicenter study in patients with morbid obesity are presented.OBJECTIVES:
To determine the reoperation rate, including band revisions, replacements, and explants, resulting from a serious adverse device-related event through years 4 and 5. Various efficacy measures were also assessed as secondary objectives.SETTING:
Nine academic and/or private institutions.METHODS:
The participating institutions enrolled 303 patients, who were then assessed on an annual basis, with 231 patients completing 5 years of follow-up. The study parameters included reoperation rates, changes in percentage of excess weight loss (%EWL), and changes in body mass index (BMI), as well as parameters of diabetes and dyslipidemia. Quality of life was assessed using the Short Form (SF)-36 and the Impact of Weight on Quality of Life-Lite questionnaires.RESULTS:
The reoperation rate due to a serious adverse event in this population at 5 years after implantation with the REALIZE gastric band was 8.9%. The most common serious adverse event was band slippage, which affected 6.9% of the study population. The mean %EWL was 35.6% ± 26.84%, and the decrease in mean BMI was -7.01 ± 5.45 kg/m2 at 5 years. Patients experienced improvements in mean glycated hemoglobin and serum lipid levels, in addition to improvements in the quality of life measures.CONCLUSION:
No new safety concerns were identified during the 5 years of follow-up. Although the results of this study did not meet the predefined safety criteria of 8% or less, the safety profile and long-term effectiveness observed in this study are consistent with those in the current literature.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Obesidad Mórbida
/
Gastroplastia
/
Laparoscopía
Tipo de estudio:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Surg Obes Relat Dis
Asunto de la revista:
METABOLISMO
Año:
2021
Tipo del documento:
Article