NCT00195949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

April 6, 2007

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

April 5, 2007

Conditions

Hypertrophic Pyloric Stenosis

Keywords

Pyloric StenosisLaparoscopyIdiopathic Hypertrophic Pyloric Stenosis

Outcome Measures

Primary Outcomes (1)

  • Operative Time

Secondary Outcomes (5)

  • Time to full feeds

  • Length of hospitalization

  • Pain medication requirements

  • Emesis episodes

  • Complications

Interventions

Laparoscopic pyloromyotomyPROCEDURE

Eligibility Criteria

AgeUp to 12 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • All patients greater than 12 weeks of age, or without parental consent, or without pyloric stenosis will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Pyloric Stenosis, HypertrophicPyloric Stenosis

Condition Hierarchy (Ancestors)

Gastric Outlet ObstructionStomach DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Daniel J Ostlie, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2003

Study Completion

February 1, 2006

Last Updated

April 6, 2007

Record last verified: 2005-09

Locations

US(1)