[PMID]: | 27049778 |
[Au] Autor: | Richmond BK; Grodman C; Walker J; Dean S; Tiley EH; Hamrick RE; Statler K; Emmett M |
[Ad] Endereço: | Department of Surgery, West Virginia University/Charleston Division, Charleston, WV. Electronic address: brichmond@hsc.wvu.edu. |
[Ti] Título: | Pilot Randomized Controlled Trial of Laparoscopic Cholecystectomy vs Active Nonoperative Therapy for the Treatment of Biliary Dyskinesia. |
[So] Source: | J Am Coll Surg;222(6):1156-63, 2016 Jun. |
[Is] ISSN: | 1879-1190 |
[Cp] País de publicação: | United States |
[La] Idioma: | eng |
[Ab] Resumo: | BACKGROUND: Despite widespread adoption by the surgical community, high-quality prospective data supporting the practice of laparoscopic cholecystectomy (LC) for the treatment of biliary dyskinesia (BD) are lacking. STUDY DESIGN: Adult patients meeting criteria for diagnosis of BD (Rome III symptoms, normal ultrasound, gallbladder ejection fraction < 38%) were randomized to either LC or a trial of nonoperative (NO) therapy with a low-dose neuromodulator (amitriptyline 25 mg/day). Patients in the NO arm were allowed to cross over to the surgical arm and remain in the study for any reason. Besides collection of basic demographics and medical/surgical history, patients were administered a standardized quality of life (QOL) assessment (Short Form-8) and a symptom-specific questionnaire (Rome III criteria) at enrollment and monthly through the study to assess the effect of treatment on biliary symptoms and overall QOL. RESULTS: Thirty patients were enrolled over 12 months (15 LC, 15 NO). In the LC group, 13 underwent LC, 1 refused surgery, 1 withdrew. In the NO group, 14 crossed over to the LC group (13 of whom had LC), yielding 26 patients who underwent LC. The SF-8 physical scores (PCS-8) were significantly improved at both the first and last follow-up visits (p < 0.0001, p = 0.0003, respectively). The SF-8 mental scores (MCS-8) were also significantly improved at both the first and last follow-up visits (p = 0.0187, p = 0.0017, respectively). With median follow-up of 12 months (range 3 to 14 months), all 26 reported relief of pain. CONCLUSIONS: This pilot study raises doubts regarding the feasibility of a randomized trial, presumably due to both clinician and patient bias toward LC and the lack of "gold-standard" nonoperative treatments. However, these prospective data indicate that, with careful patient selection (standardized symptom criteria/imaging methodology), LC results in pain relief and significant improvement in QOL in BD patients. Further prospective study of these findings is warranted. |
[Mh] Termos MeSH primário: |
Inibidores da Captação Adrenérgica/uso terapêutico Amitriptilina/uso terapêutico Discinesia Biliar/terapia Colecistectomia Laparoscópica
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[Mh] Termos MeSH secundário: |
Adolescente Adulto Idoso Esquema de Medicação Estudos de Viabilidade Feminino Seguimentos Seres Humanos Masculino Meia-Idade Projetos Piloto Estudos Prospectivos Qualidade de Vida Resultado do Tratamento Adulto Jovem
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[Pt] Tipo de publicação: | COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL |
[Nm] Nome de substância:
| 0 (Adrenergic Uptake Inhibitors); 1806D8D52K (Amitriptyline) |
[Em] Mês de entrada: | 1707 |
[Cu] Atualização por classe: | 170721 |
[Lr] Data última revisão:
| 170721 |
[Sb] Subgrupo de revista: | AIM; IM |
[Da] Data de entrada para processamento: | 160407 |
[St] Status: | MEDLINE |
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