Completed Prospective Studies Prospective Randomized Trial Evaluating the Utility of Esophageal Mobilization During Laparoscopic Fundoplication

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, 2007).

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% attrition.

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 between groups.

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.

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