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

NCT01509352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2017-01-26

No results posted yet for this study

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.

Conditions

  • Reflux

Interventions

PROCEDURE

esophageal stitches during fundoplication

placement of esophageal stitches with fundoplication

PROCEDURE

no esophageal stitches placed during fundoplication

no esophageal stitches are placed during the fundoplication procedure

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Shawn D St. Peter, MD · Children's Mercy Hospital and Clinics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2015-02-28
Completion
2015-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01509352 on ClinicalTrials.gov