Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Institute of Child Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00144924
First received: September 2, 2005
Last updated: June 12, 2008
Last verified: June 2008
  Purpose

Comparison of open and laparoscopic pyloromyotomy


Condition Intervention
Pyloric Stenosis
Procedure: pyloromyotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care

Further study details as provided by Institute of Child Health:

Primary Outcome Measures:
  • Time to full feeds [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Post operative length of stay [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Episodes of post-operative vomiting [ Time Frame: 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peri-operative complications [ Time Frame: 24h ] [ Designated as safety issue: No ]
  • Post-operative complications [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Anaesthetic time [ Time Frame: 24h ] [ Designated as safety issue: No ]
  • Operating time [ Time Frame: 24h ] [ Designated as safety issue: No ]
  • Post-operative pain and analgesia requirements [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Cosmetic outcome [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Total in-hospital costs [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2004
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: pyloromyotomy
    laparoscopic pyloromytomy
  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All infants with pyloric stenosis

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144924

Contacts
Contact: Nigel Hall, Mr n.hall@ich.ucl.ac.uk

Locations
United Kingdom
Institute of Child Health/Great Ormond Street Hospital Recruiting
London, United Kingdom
Contact: Nigel Hall, Mr       N.Hall@ich.ucl.ac.uk   
Sponsors and Collaborators
Institute of Child Health
Investigators
Principal Investigator: Nigel Hall, Mr Institute of Child Health
  More Information

No publications provided by Institute of Child Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: R&D Office, Institute of Child Health
ClinicalTrials.gov Identifier: NCT00144924     History of Changes
Other Study ID Numbers: 03SG45
Study First Received: September 2, 2005
Last Updated: June 12, 2008
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on April 15, 2014