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

Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509352
• Other study ID #: 10 01-003
• Status: Completed
• Phase: N/A
• First received: December 14, 2011
• Last updated: January 25, 2017
• Start date: February 2010
• Est. completion date: March 2015

Study information

• Verified date: January 2017
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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)

Related Conditions & MeSH terms

• Reflux

Intervention

Procedure:
• esophageal stitches during fundoplication
placement of esophageal stitches with fundoplication
• no esophageal stitches placed during fundoplication
no esophageal stitches are placed during the fundoplication procedure

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hiatal herniation		4 year follow-up