Dr Grant and colleagues from the United Kingdom determined the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-esophageal reflux disease (GERD).
The research team performed a 5-year follow-up of multicenter, pragmatic randomized trial.
Setting Initial recruitment in 21 UK hospitals.
Responders to annual questionnaires among 810 original participants.
At entry, all had had GERD for more than 12 months.
The surgeon chose the type of fundoplication.
Medical therapy was reviewed and optimized by a specialist.
Subsequent management was at the discretion of the clinician responsible for care, usually in primary care.
|44% of those randomized to surgery were taking antireflux medication |
|British Medical Journal |
The researchers' primary outcome measure included self reported quality of life score on disease-specific REFLUX questionnaire.
The team's other measures were health status, use of antireflux medication, and complications.
By 5 years, 63% of patients randomised to surgery, and 13% of those randomized to medical management had received a fundoplication.
Among responders at 5 years, 44% of those randomized to surgery were taking antireflux medication versus 82% of those randomised to medical management.
The research team noted that differences in the REFLUX score significantly favoured the randomized surgery group.
The team observed that SF-36 and EQ-5D scores also favored surgery, but were not statistically significant at 5 years.
After fundoplication, 3% had surgical treatment for a complication, and 4% had subsequent reflux-related operations—most often revision of the wrap.
The research team found that long term rates of dysphagia, flatulence, and inability to vomit were similar in the 2 randomized groups.
Dr Grant's team concludes, "After 5 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."