Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00195949
First received: September 12, 2005
Last updated: April 5, 2007
Last verified: September 2005
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   up to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195949

Locations
United States, Missouri
Children's Mercy Hospital
Kansas CIty, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Daniel J Ostlie, MD Children's Mercy Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00195949     History of Changes
Other Study ID Numbers: 03-01-004
Study First Received: September 12, 2005
Last Updated: April 5, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Constriction, Pathologic
Gastric Outlet Obstruction
Hypertrophy
Pyloric Stenosis
Pyloric Stenosis, Hypertrophic
Digestive System Diseases
Gastrointestinal Diseases
Pathological Conditions, Anatomical
Stomach Diseases

ClinicalTrials.gov processed this record on October 23, 2014