Reflux Clinical Trial
Official title:
Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication.
Verified date | January 2017 |
Source | Children's Mercy Hospital Kansas City |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Hospital | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hiatal herniation | 4 year follow-up |
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