Dr Adrian Grant and colleagues from the United Kingdom determined the relative benefits and risks of laparoscopic fundoplication surgery as an alternative to long term drug treatment for chronic gastro-oesophageal reflux disease (GERD).
The research team conducted a multicenter, pragmatic randomized trial in 21 hospitals in the United Kingdom.
The team randomized 357 participants and 453 preference participants with a mean age of 46 of which 66% men.
All participants had documented evidence of GERD and symptoms for over 12 months.
|38% randomized to surgery vs 90% to medical management were taking reflux medication|
|British Medical Journal|
The type of laparoscopic fundoplication used was left to the discretion of the surgeon.
Those allocated to medical treatment had their treatment reviewed and adjusted as necessary by a local gastroenterologist.
The team reported that subsequent clinical management was at the discretion of the clinician responsible for care.
The research team’s main outcome measures included the disease specific REFLUX quality of life score, Short Form-36, EQ-5D, and medication use.
These were measured at time points equivalent to 3 and 12 months after surgery, and surgical complications.
Randomized participants had received drugs for GERD for median of 32 months before trial entry.
Baseline REFLUX scores were 64 and 67 in the surgical and medical randomised groups, respectively.
Of those randomized to surgery, 62% actually had total or partial fundoplication.
Surgical complications were uncommon with a conversion rate less than 1% and no mortality.
The team noted that by 12 months, 38% randomized to surgery were taking reflux medication versus 90% randomized medical management.
The research team found that the REFLUX score favored the randomized surgical group.
Differences of a third to half of 1 standard deviation in other health status measures also favored the randomized surgical group.
Baseline scores in the preference for surgery group were the worst.
The researchers found that by 12 months these were better than in the preference for medical treatment group.
Dr Grant’s, “At least up to 12 months after surgery, laparoscopic fundoplication significantly increased measures of health status in patients with GERD.”