Clinical Trial: Necessity of Esophageal Dissection During Laparoscopic Fundoplication

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Trial Comparing Utility of Esophageal Crural Dissection During Laparoscopic Fundoplication in Children

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 Summary:

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.


Sponsor: Children's Mercy Hospital Kansas City

Current Primary Outcome: Hiatal hernia [ Time Frame: 1 year ]

Original Primary Outcome:

  • Hiatal hernia
  • Recurrence of reflux


Current Secondary Outcome:

  • control of symptoms [ Time Frame: 1 year ]
  • retching [ Time Frame: 1 year ]


Original Secondary Outcome:

  • control of symptoms
  • retching


Information By: Children's Mercy Hospital Kansas City

Dates:
Date Received: February 6, 2006
Date Started: February 2006
Date Completion:
Last Updated: September 21, 2009
Last Verified: March 2009