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

Completed · Not applicable

Conditions studied: Reflux

In brief

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.

Key facts

Study ID

NCT01509352

Run by

Children's Mercy Hospital Kansas City

People needed

65

Starts

2010-02-01

Expected to finish

2015-03-01

Last updated by the study team

2017-01-26

Who can join

Age: 0 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Children's Mercy Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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