Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
NCT Number: NCT00195949
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.
Looking for future studies?
Notify MeUp to 12 week
All sexes
Interventional
Phase 3
Kansas City, Missouri, 64108, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Children's Mercy Hospital Kansas City
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05068622
Digestive System Diseases, Gastric Outlet Obstruction
Amiens, France
View Trial DetailsNCT04295759
Anaplastic Astrocytoma, Anaplastic Oligodendroglioma
Los Angeles, California, United States
View Trial DetailsNCT02924402
B-Cell Non-Hodgkins Lymphoma, Blood Protein Disorders
La Jolla, California, United States
View Trial DetailsNCT03434262
Anaplastic Astrocytoma, Anaplastic Ependymoma
Memphis, Tennessee, United States
View Trial Details