Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children

Nissen fundoplication is a commonly performed procedure in infants and children with
gastroesophageal reflux and a variety of other medical conditions including respiratory
compromise, severe neurologic impairment, failure to thrive and swallowing dysfunction.
Randomized controlled trials in adults have shown that laparoscopic fundoplication is a safe
procedure that results in lower morbidity, shorter hospital length of stay and similar 5-year
recurrence rates when compared to an open procedure. The aim of this study is to compare
laparoscopic and open Nissen fundoplication in children less than 2 years of age.

Children younger than 2 years of age presenting for Nissen fundoplication will be randomized
to either a laparoscopic or an open procedure. Patients who have already undergone
anti-reflux surgery or whose hospitalization is anticipated to be prolonged by an unrelated
illness will be excluded. All procedures will be performed at a single institution by two
surgeons who will perform both the open and laparoscopic procedures.

A total of 68 patients will be needed (34 in each group) to detect a 20% difference in length
of stay at a significance level of p < 0.05 and power of 80%. Patients will be followed for
up to 2 years postoperatively. Variables to be compared between the two groups will include
age, gender, presence of neurologic impairment, presence and specification of any congenital
abnormalities, total operative time, total dose of narcotic analgesia required, postoperative
day on which the patient tolerated full feedings, postoperative and total lengths of stay as
well as the occurrence of postoperative complications (including wound infection and the need
for immediate reoperation). The primary outcomes analyzed will be length of stay and amount
of narcotic analgesia required. Longer-term outcomes including persistent GERD, wrap failure
and need for reoperation within 24 months of the initial procedure also will be determined.

Inclusion Criteria:

- clinical or radiographic diagnosis of gastroesophageal reflux

- age less than 2 years (24 months) at the time of surgery

Exclusion Criteria:

- prior fundoplication procedure

- concomitant need for an intraabdominal procedure (except gastrostomy tube placement)

- esophageal dysmotility

- hospitalization expected to be prolonged due to a concurrent illness actively being
treated (e.g. congenital heart disease requiring surgical repair during the same
hospitalization)