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Clinical Trials/NCT01509352
NCT01509352CompletedNot Applicable

Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication.

Children's Mercy Hospital Kansas City2 sites in 1 country65 target enrollmentStarted: February 1, 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
65
Locations
2
Primary Endpoint
hiatal herniation

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
1 Day to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

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

Outcomes

Primary Outcomes

hiatal herniation

Time Frame: 4 year follow-up

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Children's Mercy Hospital Kansas City
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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