Five-year subjective and objective results of laparoscopic and conventional Nissen fundoplication: a randomized trial

Abstract

Objective: The purpose of this prospective study was to compare the subjective and objective outcome of laparoscopic (LNF) and conventional Nissen fundoplication (CNF) up to 5 years after surgery as obtained in a multicenter randomized controlled trial.

Summary of background data: LNF is regarded as surgical treatment of first choice for refractory gastroesophageal reflux disease by many surgeons based on several short- and mid-term studies. The long-term efficacy of Nissen fundoplication, however, is still questioned as objective data gathered from prospective studies are lacking.

Methods: From 1997 to 1999, 177 patients were randomized to undergo LNF or CNF. Five years after surgery, all patients were requested to fill in questionnaires and to undergo esophageal manometry and 24-hour pH-metry.

Results: A total of 148 patients agreed to participate in the follow-up study: 79 patients after LNF and 69 after CNF. Of these, 97 patients (48 LNF, 49 CNF) consented to undergo esophageal manometry and 24-hour pH-metry. At 5 years follow-up, 20 patients had undergone reoperation: 12 after LNF (15%) and 8 after CNF (12%). There was no difference in subjective outcome, with overall satisfaction rates of 88% and 90%, respectively. Total esophageal acid exposure times (pH < 4) were 2.1% +/- 0.5% and 2.0% +/- 0.6%, respectively (P = 0.21). Antisecretory medication was taken daily in 14% and 16%, respectively (P = 0.29). There was no correlation between medication use and acid exposure and indices of symptom-reflux association (symptom index and symptom association probability). No significant differences between subjective and objective results at 3 to 6 months and results obtained at 5 years after surgery were found.

Conclusions: The effects of LNF and CNF on general state of health and objective reflux control are sustained up to 5 years after surgery and the long-term results of LNF and CNF are comparable. A substantial minority of patients in both groups had a second antireflux operation or took antisecretory drugs, although the use of those medications did not appear to be related to abnormal esophageal acid exposure.

FIGURE 1. Study profile.

FIGURE 2. Mean preoperative, 3 to 6 months postoperative and 5 years postoperative upright, supine and total acid exposure for LNF.

FIGURE 3. Mean preoperative, 3 to 6 months postoperative and 5 years postoperative upright, supine and total acid exposure for CNF.

FIGURE 4. Time curve of percentage of patients free from reintervention for recurrent GERD and CNF and LNF.