Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287612
Status:
COMPLETED
Last Update Posted:
2009-09-22
First Post:
2006-02-06
Brief Title:
Necessity of Esophageal Dissection During Laparoscopic Fundoplication
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Prospective Trial Comparing Utility of Esophageal Crural Dissection During Laparoscopic Fundoplication in Children
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study compares complete dissection of the tissue around the lower esophagus to no dissection of these tissues during laparoscopic fundoplication in children
Detailed Description:
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 005 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
Sample size calculated on a power of 80 with an alpha level of 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None