A Phase 3 interventional study of Laparoscopic pyloromyotomy in Hypertrophic Pyloric Stenosis, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to participants aged Up to 12 Weeks. Per ClinicalTrials.gov, last updated 2007-04-06.
Sponsored by Children's Mercy Hospital Kansas City · Phase 3, Interventional, and Treatment
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.
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.
29 studies on the registry are indexed under Pyloric Stenosis; 1 is open to participants now.
This study's enrollment of 200 is above the median of 69 across 20 interventional studies indexed under Pyloric Stenosis.
Browse Pyloric Stenosis studies →Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Operative Time
Time to full feeds
Length of hospitalization
Pain medication requirements
Emesis episodes
Complications
This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.
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Children's Mercy Hospital Kansas City