Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
65 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal