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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01509352
First received: December 14, 2011
Last updated: January 18, 2016
Last verified: January 2016

December 14, 2011
January 18, 2016
February 2010
February 2015   (final data collection date for primary outcome measure)
hiatal herniation [ Time Frame: 4 year follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01509352 on ClinicalTrials.gov Archive Site
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Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Reflux
  • Procedure: esophageal stitches during fundoplication
    placement of esophageal stitches with fundoplication
    Other Name: crural stitches.
  • Procedure: no esophageal stitches placed during fundoplication
    no esophageal stitches are placed during the fundoplication procedure
    Other Name: crural stitches
  • Active Comparator: with esophageal stitches
    fundoplication with crural stitches
    Intervention: Procedure: esophageal stitches during fundoplication
  • Experimental: without esophageal stitches
    fundoplication without crural stitches.
    Intervention: Procedure: no esophageal stitches placed during fundoplication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
March 2015
February 2015   (final data collection date for primary outcome measure)

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)
Both
up to 7 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01509352
10 01-003
No
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Children's Mercy Hospital Kansas City
Children's Mercy Hospital Kansas City
Not Provided
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital and Clinics
Children's Mercy Hospital Kansas City
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP