Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00195949
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 6, 2007
Information provided by:
Children's Mercy Hospital Kansas City

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.

Condition or disease Intervention/treatment Phase
Hypertrophic Pyloric Stenosis Procedure: Laparoscopic pyloromyotomy Phase 3

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 Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
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
Study Start Date : April 2003
Actual Study Completion Date : February 2006

Primary Outcome Measures :
  1. Operative Time

Secondary Outcome Measures :
  1. Time to full feeds
  2. Length of hospitalization
  3. Pain medication requirements
  4. Emesis episodes
  5. Complications

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00195949     History of Changes
Other Study ID Numbers: 03-01-004
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 6, 2007
Last Verified: September 2005

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