St. Peter, Shawn D.; Bamhart, Douglas C.; Ostlie, Daniel J.;
Tsao, KuoJen; Leys, Charles M.; Sharp, Susan M.; Bartle, Donna;
Morgan, Tracey; Harmon, Carroll M.; Georgeson, Keith E.; Holcomb
III, George W. "Minimal vs Extensive Esophageal Mobilization During
Laparoscopic Fundoplication: A Prospective Randomized Trial."
Journal of Pediatric Surgery. 46, (2011): 163-168.
This is a two-center, prospective randomized clinical trial
involving patients who require an operation for gastroesophageal
reflux disease. This is intended to be a definitive study. All
patients will receive the standard operation for GE reflux:
laparoscopic Nissen fundoplication.
There is controversy as to whether the esophagus should be
mobilized extensively in the abdomen. Also, from our
retrospective data, there appears to be an increased (12% vs. 5%)
incidence of transmigration of the fundoplication wrap if the
esophagus is extensively mobilized (J Pediatr Surg 42:25-30,
Sample size calculated on a power of 80% with an alpha level of
0.05 using the recurrence rates demonstrated by our retrospective
data produce the number of 159 patients in each arm of the study.
Given that we will need to follow these patients for one year after
enrollment, there may be some attrition due to lost follow-up.
Therefore, 180 patients per arm would allow for just over 10%
One group undergoes laparoscopic fundoplication with complete
mobilization of the lower esophagus by circumferentially dividing
the phrenoesophageal membrane. The other group undergoes
laparoscopic fundoplication without dividing this membrane. In
both groups, four esophago-crural sutures are placed to secure the
esophagus in the abdomen (see the above-mentioned report in the
Journal of Pediatric Surgery). The operation,
postoperative care and follow-up plan will otherwise not differ
If four consecutive recurrences are found in one group, an
interim analysis will be conducted. If a recurrence
difference of statistical significance between groupsis is
detected, the study will be concluded at this point. Without these
occurrences, an interim analysis will be conducted after 180
patients have been enrolled. The primary endpoint is the incidence
of wrap transmigration.