Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195949
Status:
COMPLETED
Last Update Posted:
2007-04-06
First Post:
2005-09-12
Brief Title:
Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Pyloromyotomy for pyloric stenosis has traditionally been performed via an open technique With advancements in minimally invasive surgery in infants a laparoscopic approach has been developed These two approaches have never been critically evaluated with regard to superiority of one technique over the other This is a prospective randomized trial involving infants with pyloric stenosis It will enroll 100 patients in each arm statistical and power analysis was performed by Steve Simon PhD Parental consent will be obtained and the patients will be randomized to undergo open or laparoscopic pyloromyotomy Patient age at diagnosis electrolyte disturbances at diagnosis ultrasound findings operative approach length of pyloromyotomy operative times time to tolerating full feeds number of emesis episodes length of hospitalization operative charges and hospital charges will be collected for comparison between the groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None