Evidence-based appraisal of antireflux fundoplication.

OBJECTIVE: To highlight the current available evidence in antireflux surgery through a systematic review of randomized controlled trials (RCTs).

SUMMARY BACKGROUND DATA: Laparoscopic fundoplication is currently suggested as the gold standard for the surgical treatment of gastroesophageal reflux disease, but many controversies are still open concerning the influence of some technical details on its results.

METHODS: Papers related to RCTs identified via a systematic literature search were evaluated according to standard criteria. Data regarding the patient sample, study methods, and outcomes were abstracted and summarized across studies. Defined outcomes were examined for 41 papers published from 1974 to 2002 related to 25 RCTs. A meta-analysis was performed pooling the results as odds ratios (OR), rate differences (RD), and number needed to treat (NNT). Data given as mean and/or median values were pooled as a mean +/- SD (SD).

RESULTS: No perioperative deaths were found in any of the RCTs. Immediate results showed a significantly lower operative morbidity rate (10.3% versus 26.7%, OR 0.33, RD -12%, NNT 8), shorter postoperative stay (3.1 versus 5.2 days, P = 0.03), and shorter sick leave (20.1 versus 35.8 days, P = 0.03) for laparoscopic versus open fundoplication. No significant differences were found regarding the incidence of recurrence, dysphagia, bloating, and reoperation for failure at midterm follow-up. No significant differences in operative morbidity (13.1% versus 9.4%) and in operative time (90.2 versus 84.2 minutes) were found in partial versus total fundoplication. A significantly lower incidence of reoperation for failure (1.6% versus 9.6%, OR 0.21, RD -7%, NNT 14) was found after partial fundoplication, with no significant differences regarding the incidence of recurrence and/or dysphagia. Routine division of short gastric vessels during total fundoplication showed no significant advantages regarding the incidence of postoperative dysphagia and recurrence when compared with no division. The use of ultrasonic scalpel compared with clips or bipolar cautery for the division of short gastric vessels showed no significant effect on operative time, postoperative complications, and costs.

CONCLUSIONS: Laparoscopic antireflux surgery is at least as safe and as effective as its open counterpart, with reduced morbidity, shortened postoperative stay, and sick leave. Partial fundoplication significantly reduces the risk of reoperations for failure over total fundoplication. Routine versus no division of short gastric vessels showed no significant advantages. A word of caution is needed when implementing these results derived from RCTs performed in specialized centers into everyday clinical practice, where experience and skills may be suboptimal.