Hypertrophic Pyloric Stenosis Clinical Trial
Official title:
Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis
Pyloric stenosis is a condition that develops in infants and that leads to an obstruction of the channel going out of the stomach. This study is being performed to determine if there is an advantage to the laparoscopic approach or the open approach for the surgical correction of the enlarged pylorus.
Status | Completed |
Enrollment | 200 |
Est. completion date | February 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 12 Weeks |
Eligibility |
Inclusion Criteria: - All infants less than 12 weeks of age who have undergone surgical consultation and abdominal ultrasound confirming the diagnosis of pyloric stenosis and whose parents have given consent for inclusion in the study. Exclusion Criteria: - All patients greater than 12 weeks of age, or without parental consent, or without pyloric stenosis will be excluded from the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 | Operative Time | |||
Secondary | Time to full feeds | |||
Secondary | Length of hospitalization | |||
Secondary | Pain medication requirements | |||
Secondary | Emesis episodes | |||
Secondary | Complications |
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