PHILADELPHIA — Laparoscopic Nissen fundoplication appears to offer better overall control of gastroesophageal reflux disease symptoms than does optimized medical therapy for patients who are stable and symptomatically controlled on long-term medical therapy, according to a randomized study of 101 patients.
At 3 years after the start of the trial, surgical patients generally had more symptom-free days, greater satisfaction with their control of symptoms, less esophageal acid exposure, and better quality of life than did patients who received optimal proton pump inhibitor (PPI) therapy throughout the trial, Dr. Mehran Anvari reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.
In a randomized, nonblinded study, Dr. Anvari, director of the centre for minimal access surgery at McMaster University, Hamilton, Ont., and his colleagues compared the 3-year results of 101 patients who underwent either laparoscopic Nissen fundoplication or optimized PPI therapy.
The patients had controlled their GERD symptoms with PPIs but still required long-term PPI therapy. All of them had been taking PPIs continuously for at least 1 year and had good symptom control—a GERD symptom scale (GSS) score of less than 18 on a range of 0–60 and a visual analog scale score of greater than 70 on a range of 1–100.
The operations were done by four surgeons who each had performed more than 50 laparoscopic Nissen fundoplication procedures. Surgical patients stopped using PPIs after their operation. Patients randomized to medical therapy received treatment using a standardized management protocol based on best evidence and published guidelines.
The average GSS scores were similar in both groups at 1 and 3 years. At 3 years, the 51 patients randomized to surgery had an average of nearly 7 symptom-free days a week, compared with about 6 a week in the 50 patients randomized to medical therapy. Unlike medical therapy, surgery was associated with normalization of lower esophageal sphincter pressure.
On 24-hour pH monitoring at 3 years, surgical patients spent a mean of 2% of the duration of monitoring with a distal esophageal pH less than 4, but patients on medical therapy spent more than 4% of the duration with a pH below 4 even though they remained on PPIs. However, each group had a similar drop in the percentage of time spent at a pH less than 4.
At 3 years, satisfaction with symptom control was 15% higher in surgical patients than it was in patients on medical therapy. Although both treatments helped patients maintain a high quality of life as measured on the Short Form-36 questionnaire, surgery was superior to medical therapy in improving quality of life, said Dr. Anvari, professor of general surgery at the university.
Treatment failures occurred in 18% of surgical patients (three required revisions because of persistent dysphagia, and six needed PPI therapy) and in 16% of patients on medical therapy (eight required surgery).
“Laparoscopic Nissen fundoplication should be offered to patients requiring more than 2 years of PPI therapy who are seeking alternatives. And it should be a standard for comparison [against] all endoscopic antireflux procedures that are being devised,” Dr. Anvari advised.
He reported no relevant conflicts of interest and said there was no industry involvement in the conduct of the study.