Necessity of Esophageal Dissection During Laparoscopic Fundoplication
|Gastroesophageal Reflux Disease Hiatal Hernia||Procedure: Lap. Fundo. with Mobilization of the Esophageal Junction Procedure: Lap. Fundo. without Mobilization of the Esophageal Junction|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Trial Comparing Utility of Esophageal Crural Dissection During Laparoscopic Fundoplication in Children|
- Hiatal hernia [ Time Frame: 1 year ]
- control of symptoms [ Time Frame: 1 year ]
- retching [ Time Frame: 1 year ]
|Study Start Date:||February 2006|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Arms:Lap. Fundo. with Mobilization of the Esophageal Junction
Procedure: Lap. Fundo. with Mobilization of the Esophageal Junction
Complete mobilization of the esophageal junction
Procedure: Lap. Fundo. without Mobilization of the Esophageal Junction
phrenoesophageal membrane left intact
This will be a 2-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 reflux: laparoscopic fundoplication. The dissection will be performed by either separating the phrenoesophageal membrane, or by leaving the phrenoesophageal membrane intact.
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 a number of 159 patients in each arm of the study. Given that we will need to follow these patients for 1 year after enrollment, there may be some attrition due to lost follow-up. Therefore 180 patients per arm would account for just over 10% attrition.
One group will undergo laparoscopic fundoplication with complete mobilization of the lower esophagus by circumferentially dividing the phrenoesophageal membrane. The other group will undergo laparoscopic fundoplication without dividing this membrane. The operation, post-operative care, and follow-up plan will otherwise not differ between groups.
If 4 consecutive recurrences are found in one group, an interim analysis will be conducted. If a recurrence difference between groups of statistical significance is detected, the study will be concluded at this point. Without this occurrence, an interim analysis will be conducted at 180 patients enrolled.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287612
|United States, Alabama|
|Children's Hospital of Alabama|
|Birmingham, Alabama, United States, 35233|
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Shawn D St. Peter, MD||Children's Mercy Hospital|