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Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

This study has been completed.
Information provided by:
Children's Mercy Hospital Kansas City Identifier:
First received: September 12, 2005
Last updated: April 5, 2007
Last verified: September 2005
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.

Condition Intervention Phase
Hypertrophic Pyloric Stenosis Procedure: Laparoscopic pyloromyotomy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Operative Time

Secondary Outcome Measures:
  • Time to full feeds
  • Length of hospitalization
  • Pain medication requirements
  • Emesis episodes
  • Complications

Estimated Enrollment: 200
Study Start Date: April 2003
Study Completion Date: February 2006
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.

Ages Eligible for Study:   up to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00195949

United States, Missouri
Children's Mercy Hospital
Kansas CIty, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Principal Investigator: Daniel J Ostlie, MD Children's Mercy Hospital
  More Information Identifier: NCT00195949     History of Changes
Other Study ID Numbers: 03-01-004
Study First Received: September 12, 2005
Last Updated: April 5, 2007

Keywords provided by Children's Mercy Hospital Kansas City:
Pyloric Stenosis
Idiopathic Hypertrophic Pyloric Stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Pyloric Stenosis
Gastric Outlet Obstruction
Pyloric Stenosis, Hypertrophic
Pathological Conditions, Anatomical
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on August 22, 2017