LOS ANGELES — Laparoscopic Nissen fundoplication is superior to medication for overall symptom control in patients with gastroesophageal reflux disease, according to preliminary research presented at the annual Digestive Disease Week.
Even patients who do well on medication may be candidates for surgery, said Dr. Mehran Anvari, director of the center for minimal access surgery at McMaster University in Hamilton, Ont., the study's lead author. Dr. Anvari presented the 1-year results of the study, in which patients whose symptoms were controlled by long-term use of proton pump inhibitors (PPIs) were randomized to receive either continued PPI therapy or laparoscopic Nissen fundoplication.
Of the more than 200 patients with gastroesophageal reflux disease (GERD) who were eligible for the study, 104 gave informed consent. Four surgeons performed the surgery, using a previously published technique. Investigators evaluated symptoms every 3 months using a validated instrument and conducted 24-hour pH testing after 1 year.
Of the 104 randomized patients, 98 were available for follow-up after 1 year. Patients in both arms of the study showed improvement in 24-hour pH and in GERD symptoms. However, overall patient satisfaction with symptom control in the surgical group increased from 73.3 to 90.2 on a 100-point global rating scale, whereas results from the medication group stayed the same, compared with baseline.
Laparoscopic Nissen fundoplication may be an alternative for patients who don't want to be on long-term therapy with medication, Dr. Anvari said. Although this trial showed surgery to be an effective option, particularly in terms of overall symptom control, surgery is operator dependent, he said.
For this study, the investigators selected surgeons who had performed 50 or more laparoscopic Nissen fundoplication procedures. Dr. Anvari said that patients should select surgeons who have done at least 30 of these procedures. The 3-year follow-up data are collected and will be released in about a year, he said.