Introduction: The use of a large esophageal stent to guage the tightness of
a Nissen fundoplication has been widely accepted as dogma with very little
scientific verification. We present the results of a randomized prospective
study on laparoscopic Nissens with or without the use of an esophageal stent to
determine the incidence of bougie related complications and the relative
incidence and severity of post operative dysphagia.
Methods: Patients scheduled for an elective antireflux surgery at one
institution were randomly assigned to one of two groups. Group I had a standard
laparoscopic Nissen with a large esophageal bougie (56 Fr). Group II had
exactally the same repair with no bougie. Patients with giant paraesophogeal
hernias, Collis lengthening procedures or partial fundoplications (done for
motility disorders) were excluded from this analysis. Complications related to
bougie use were recorded. Dysphagia was assessed according to a frequency and
severety score preop, immediately postop (< 4 weeks) and for long term (>4
weeks). Results were tabulated and subjected to a student - T test for
statistical validity.
Results: Between 3/96 and 12/96 88 laparoscopic antireflux surgeries were
randomized to the study. 38 met the criteria of simple, uncomplicated Nissen
fundoplications and were analyzed for this study. Data was collected in a
blinded fasion. There were 20 patiens in the no stent group and 18 in the
stented group. The incidence of bougie injuries in group I was 5%(I pharyngeal
laceration). Preoperative dysphagia was present in 40% of group I and 67% of
group II. Early postop dysphagia was noted in 84% of group I and 62% of group
II. Late dysphagia was described in 47% and 36% respectedly for group I and II.
No patients in either group have recieved intervention for their dysphagia. The
mean dysphagia score for group I for the three time frames was 3.4, 10.5, 1.9
respectively. For group II the scores were 7.1, 4.2, 1.9. These differences were
significant for the early postop group (p=.03) but not for the preop score
(p=.13) or for the late post op period (p=.93).
Conclusion: We present the first randomized prospective study that attempts
to validate the use of esophageal stenting in Nissen fundoplication and show
that there is, infact, a higher incidence of transient dysphagia in patients
when a bougie is not used. On the other hand, long term dysphagia rates were not
different. The avoidence of early dysphagia must be balanced against an
incidence of bougie related injuries (5%) during the laparoscopic procedure.
Based on these results we feel that the routine use of an esophageal stent
during a laparoscopic fundoplication is not indicated.
