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Evidence-Based Appraisal of Antireflux Fundoplication

Catarci, Marco MD*; Gentileschi, Paolo MD*; Papi, Claudio MD†; Carrara, Alessandro MD*; Marrese, Renato MD*; Gaspari, Achille Lucio MD*; Grassi, Giovanni Battista MD*


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.

The serendipitous discovery of the antireflux effect of wrapping the gastric fundus around the distal esophagus1 led Rudolph Nissen to perform the first fundoplication for gastroesophageal reflux disease (GERD) nearly half a century ago.2 Since then, various technical details of total fundoplication3–5 or partial fundoplications6–8 have been suggested. In 1991, the so-called “Nissen fundoplication” was performed for the first time through a laparoscopic approach.9,10 To date, various large series showed its safety, efficacy, good quality of life, short hospital stay, early return to work, and cost savings.11–14 However, little is known about the reproducibility of such results in nonspecialized centers,15 and about current indications and results faced by long-term acid suppression therapy.16,17 Gastroenterologists and surgeons definitely do not share the same enthusiasm in surgical referral of patients with GERD.18 The gastroenterological medical community appears at least skeptical about the efficacy of laparoscopic antireflux surgery,19–21 claiming also that too many technical modifications of fundoplication are performed and complications are often blamed on 1 type of modification or another.19,20 Furthermore, a recently introduced third party – endoscopic augmentation of lower esophageal sphincter pressure22,23 – might potentially compete in this arena.

When one of the authors, already experienced in laparoscopic antireflux surgery, moved to his current hospital, he needed to establish a new surgical referral of patients with GERD. He was asked to provide the available evidence on current status of antireflux surgery, and this need prompted this review.

Evidence-based answers to current controversies in open versus laparoscopic surgery for gastroesophageal reflux disease, including the impact of technical details on outcomes, are given in this systematic review of randomized controlled trials.

From the *Department of Surgery and the † Department of Gastroenterology, San Filippo Neri Hospital, Rome, Italy and the ‡Department of Surgery, Tor Vergata University, Rome, Italy.

Reprints: Marco Catarci, MD, UOC Chirurgia Generale & Oncologica; ACO San Filippo Neri, Via G. Martinotti, 20-00135 Roma, Italy. E-mail:

© 2004 Lippincott Williams & Wilkins, Inc.