Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches 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

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2015-03-31

Brief Summary

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This is a prospective trial of the utility of esophageal stitches during fundoplication.

The hypothesis is that recurrence rate may be different with or without the esophageal stitches.

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Detailed Description

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This will be a single 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 leaving the phrenoesophageal membrane intact in all patients.

One group will undergo laparoscopic fundoplication with 4 esophageal-crural sutures while the other group will not have these placed. The operation, post-operative care, and follow-up plan will otherwise not differ between groups.

Conditions

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Reflux

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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with esophageal stitches

fundoplication with crural stitches

Group Type ACTIVE_COMPARATOR

esophageal stitches during fundoplication

Intervention Type PROCEDURE

placement of esophageal stitches with fundoplication

without esophageal stitches

fundoplication without crural stitches.

Group Type EXPERIMENTAL

no esophageal stitches placed during fundoplication

Intervention Type PROCEDURE

no esophageal stitches are placed during the fundoplication procedure

Interventions

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esophageal stitches during fundoplication

placement of esophageal stitches with fundoplication

Intervention Type PROCEDURE

no esophageal stitches placed during fundoplication

no esophageal stitches are placed during the fundoplication procedure

Intervention Type PROCEDURE

Other Intervention Names

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crural stitches. crural stitches

Eligibility Criteria

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Inclusion Criteria

Patients less than 7 years of age requiring fundoplication for gastroesophageal reflux disease who are considered good laparoscopic candidates by the staff surgeon will be considered candidates.

Exclusion Criteria

1. Hiatal hernia demonstrated on preoperative contrast study, computed tomography, endoscopy, or intraoperative findings.
2. Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)
3. Prior operation for congenital diaphragmatic hernia
4. 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)

Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No