Necessity of Esophageal Dissection During Laparoscopic Fundoplication

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287612
• Other study ID #: 05 12-150
• Status: Completed
• Phase: N/A
• First received: February 6, 2006
• Last updated: September 21, 2009
• Start date: February 2006
• Est. completion date: August 2009

Study information

• Verified date: March 2009
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study compares complete dissection of the tissue around the lower esophagus to no dissection of these tissues during laparoscopic fundoplication in children.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Under 18 years of age

• Gastroesophageal Reflux Disease

Exclusion Criteria:

1. Hiatal hernia demonstrated on preoperative contrast study, computed tomography or endoscopy

2. Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)

3. Prior operation for congenital diaphragmatic hernia

4. Patient or family circumstance that will create difficulty attaining one-year follow-up (e.g. referral from distance or anticipated relocation of family)

5. Patients not considered laparoscopic candidates by the staff surgeon or anesthesiologist (e.g. carbon dioxide retaining lung disease, congenital heart disease, or complex previous abdominal operations)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Hernia, Hiatal
• Hiatal Hernia

Intervention

Procedure:
• Lap. Fundo. with Mobilization of the Esophageal Junction
Complete mobilization of the esophageal junction
• Lap. Fundo. without Mobilization of the Esophageal Junction
phrenoesophageal membrane left intact

Locations

Country	Name	City	State
United States	Children's Hospital of Alabama	Birmingham	Alabama
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hiatal hernia		1 year	No
Secondary	control of symptoms		1 year	No
Secondary	retching		1 year	No