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Sponsors and Collaborators: |
Children's Mercy Hospital Kansas City University of Alabama at Birmingham |
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Information provided by: | Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT00287612 |
This study compares complete dissection of the tissue around the lower esophagus to no dissection of these tissues during laparoscopic fundoplication in children.
Condition | Intervention |
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Gastroesophageal Reflux Disease Hiatal Hernia |
Procedure: Lap. Fundo. with Mobilization of the Esophageal Junction Procedure: Lap. Fundo. without Mobilization of the Esophageal Junction |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective Trial Comparing Utility of Esophageal Crural Dissection During Laparoscopic Fundoplication in Children |
Estimated Enrollment: | 360 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Arms:Lap. Fundo. with Mobilization of the Esophageal Junction
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Procedure: Lap. Fundo. with Mobilization of the Esophageal Junction
Complete mobilization of the esophageal junction
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2: Experimental |
Procedure: Lap. Fundo. without Mobilization of the Esophageal Junction
phrenoesophageal membrane left intact
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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.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Children's Mercy Hospital ( Shawn St. Peter ) |
Study ID Numbers: | 05 12-150 |
Study First Received: | February 6, 2006 |
Last Updated: | March 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00287612 History of Changes |
Health Authority: | United States: Food and Drug Administration |
GERD Hiatal Hernia Recurrence |
Pathological Conditions, Anatomical Deglutition Disorders Esophageal Motility Disorders Hernia, Hiatal Digestive System Diseases Esophageal Disorder |
Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Esophageal Diseases Gastroesophageal Reflux Recurrence |
Pathological Conditions, Anatomical Deglutition Disorders Esophageal Motility Disorders Hernia, Hiatal Digestive System Diseases |
Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Esophageal Diseases Gastroesophageal Reflux |