Necessity of Esophageal Dissection During Laparoscopic Fundoplication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Disease Hiatal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Arms:Lap. Fundo. with Mobilization of the Esophageal Junction

Group Type ACTIVE_COMPARATOR

Lap. Fundo. with Mobilization of the Esophageal Junction

Intervention Type PROCEDURE

Complete mobilization of the esophageal junction

2

Group Type EXPERIMENTAL

Lap. Fundo. without Mobilization of the Esophageal Junction

Intervention Type PROCEDURE

phrenoesophageal membrane left intact

Interventions

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Lap. Fundo. with Mobilization of the Esophageal Junction

Complete mobilization of the esophageal junction

Intervention Type PROCEDURE

Lap. Fundo. without Mobilization of the Esophageal Junction

phrenoesophageal membrane left intact

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No