Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX).
BMJ
; 346: f1908, 2013 Apr 18.
Article
em En
| MEDLINE
| ID: mdl-23599318
ABSTRACT
OBJECTIVES:
To determine the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-oesophageal reflux disease (GORD).DESIGN:
Five year follow-up of multicentre, pragmatic randomised trial (with parallel non-randomised preference groups).SETTING:
Initial recruitment in 21 UK hospitals.PARTICIPANTS:
Responders to annual questionnaires among 810 original participants. At entry, all had had GORD for >12 months. INTERVENTION The surgeon chose the type of fundoplication. Medical therapy was reviewed and optimised by a specialist. Subsequent management was at the discretion of the clinician responsible for care, usually in primary care. MAIN OUTCOMEMEASURES:
Primary outcome measure was self reported quality of life score on disease-specific REFLUX questionnaire. Other measures were health status (with SF-36 and EuroQol EQ-5D questionnaires), use of antireflux medication, and complications.RESULTS:
By five years, 63% (112/178) of patients randomised to surgery and 13% (24/179) of those randomised to medical management had received a fundoplication (plus 85% (222/261) and 3% (6/192) of those who expressed a preference for surgery and for medical management). Among responders at 5 years, 44% (56/127) of those randomised to surgery were taking antireflux medication versus 82% (98/119) of those randomised to medical management. Differences in the REFLUX score significantly favoured the randomised surgery group (mean difference 8.5 (95% CI 3.9 to 13.1), P<0.001, at five years). SF-36 and EQ-5D scores also favoured surgery, but were not statistically significant at five years. After fundoplication, 3% (12/364) had surgical treatment for a complication and 4% (16) had subsequent reflux-related operations-most often revision of the wrap. Long term rates of dysphagia, flatulence, and inability to vomit were similar in the two randomised groups.CONCLUSIONS:
After five years, laparoscopic fundoplication continued to provide better relief of GORD symptoms than medical management. Adverse effects of surgery were uncommon and generally observed soon after surgery. A small proportion had re-operations. There was no evidence of long term adverse symptoms caused by surgery. TRIAL REGISTRATION Current Controlled Trials ISRCTN15517081.
Texto completo:
1
Coleções:
01-internacional
Temas:
Geral
/
Cirurgia_oncologica
Base de dados:
MEDLINE
Assunto principal:
Refluxo Gastroesofágico
/
Fundoplicatura
/
Procedimentos Cirúrgicos Minimamente Invasivos
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Limite:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
BMJ
Assunto da revista:
MEDICINA
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Reino Unido