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OpenTrials
Completed

NCT Number: NCT01509352

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

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.

Completed

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Key information

Age range

1 day–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

esophageal stitches during fundoplication

Procedure

placement of esophageal stitches with fundoplication

Other names: crural stitches.

no esophageal stitches placed during fundoplication

Procedure

no esophageal stitches are placed during the fundoplication procedure

Other names: crural stitches

Primary outcomes

  1. hiatal herniation

    Time frame: 4 year follow-up

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jan 13, 2012
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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