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

This study is currently recruiting participants.
Verified January 2012 by Children's Mercy Hospital Kansas City
Sponsor:
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01509352
First received: December 14, 2011
Last updated: January 10, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Reflux
 Procedure: esophageal stitches during fundoplication
Procedure: no esophageal stitches placed during fundoplication

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • hiatal herniation [ Time Frame: 4 year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: February 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: with esophageal stitches
fundoplication with crural stitches
 Procedure: esophageal stitches during fundoplication
placement of esophageal stitches with fundoplication
Other Name: crural stitches.
Experimental: without esophageal stitches
fundoplication without crural stitches.
 Procedure: no esophageal stitches placed during fundoplication
no esophageal stitches are placed during the fundoplication procedure
Other Name: crural stitches

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509352

Contacts
Contact: Shawn D St. Peter, MD 816 983-6479 sspeter@cmh.edu
Contact: Susan W Sharp, PhD 816-983-6670 swsharp@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Shawn D St. Peter, MD     816-983-6479     sspeter@cmh.edu    
Contact: Susan W Sharp, PhD     816-983-6670     swsharp@cmh.edu    
Principal Investigator: Shawn D St. Peter, MD            
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital and Clinics
  More Information

No publications provided

Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01509352     History of Changes
Other Study ID Numbers: 10 01-003
Study First Received: December 14, 2011
Last Updated: January 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
fundoplication
gastric reflux

ClinicalTrials.gov processed this record on May 19, 2013