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-esophageal reflux disease (GORD).
The research team undertook a multicenter, pragmatic randomized trial, with parallel preference groups in 21 hospitals in the United Kingdom.
The team randomized 357 surgical and medical participants, and 453 preference participants.
All participants had documented evidence of GERD and symptoms for more than 12 months.
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 team’s main outcome measures included the disease specific REFLUX quality of life score, Short Form-36, EQ-5D, medication use, and surgical complications.
These outcomes were measured at time points equivalent to 3 and 12 months after surgery.
Randomized participants had received drugs for GERD for a median of 32 months before trial entry.
The research team noted that baseline REFLUX scores were 64 and 67 in the surgical and medical randomized groups, respectively.
Of those randomized to surgery, 62% actually had total or partial fundoplication.
Surgical complications were uncommon with a conversion rate of less than 1%, and no mortality.
The team found that by 12 months, 38% randomized to surgery were taking reflux medication versus 90% randomized to medical management.
The team observed that the REFLUX score favored the randomized surgical group.
Differences of a 33% to 50% of 1 standard deviation in other health status measures also favored the randomized surgical group.
The researchers noted that baseline scores in the preference for surgery group were the worst.
By 12 months, the baseline scores were better than in the preference for medical treatment group.
Dr Grant’s team commented, “At least up to 12 months after surgery, laparoscopic fundoplication significantly increased measures of health status in patients with GERD.”