Necessity of Esophageal Dissection During Laparoscopic Fundoplication

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease; Hiatal Hernia
• Interventions: Procedure: Lap. Fundo. with Mobilization of the Esophageal Junction; Procedure: Lap. Fundo. without Mobilization of the Esophageal Junction

• Registration Number: NCT00287612
• Lead Sponsor: Children's Mercy Hospital Kansas City

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 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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Status Verified: 2009-03
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2009-09-21
• Last Update Posted: 2009-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lap. Fundo. with Mobilization of the Esophageal Junction	Arms:Lap. Fundo. with Mobilization of the Esophageal Junction
2	Lap. Fundo. without Mobilization of the Esophageal Junction	-

Primary Outcome Measures

Name	Time	Method
Hiatal hernia	1 year

Secondary Outcome Measures

Name	Time	Method
control of symptoms	1 year
retching	1 year

Trial Locations

Locations (2)

Children's Hospital of Alabama; 🇺🇸 Birmingham, Alabama, United States

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States