Background: Laparoscopic Nissen fundoplication has gained wide accepta
nce among surgeons, but the results of the laparoscopic procedure have
not been compared to the results of an open fundoplication in a rando
mized study. Methods: Some 110 consecutive patients with prolonged sym
ptoms of grade II-IV esophagitis were randomized, 55 to laparoscopic (
LAP) and 55 to an open (OPEN) Nissen fundoplication. Postoperative rec
overy, complications, and outcome at 3- and 12-month follow-up were co
mpared in the two groups. Results: Five LAP operations were converted
to open laparotomy due to esophageal perforation (two), technical diff
iculties (two), and bleeding (one). In the OPEN group (two) patients u
nderwent splenectomy, There was no mortality. The mean hospital stay w
as 3.2 days in the LAP group and 6.4 in the OPEN group. Dysphagia and
gas bloating were the most common complaints 3 months after the operat
ion in both groups, These symptoms had disappeared at the 12-month fol
low-up examination. All patients in the LAP group and 86% in the OPEN
group were satisfied with the result. Conclusions: Laparoscopic Nissen
fundoplication is a safe and feasible procedure. Complications are fe
w and functional results are good if not better than those of conventi
onal open surgery.