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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with esophageal stitches | Active Comparator | fundoplication with crural stitches |
|
| without esophageal stitches | Experimental | fundoplication without crural stitches. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esophageal stitches during fundoplication | Procedure | placement of esophageal stitches with fundoplication |
|
| Measure | Description | Time Frame |
|---|---|---|
| hiatal herniation | 4 year follow-up |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Shawn D St. Peter, MD | Children's Mercy Hospital and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
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| no esophageal stitches placed during fundoplication | Procedure | no esophageal stitches are placed during the fundoplication procedure |
|
|
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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