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Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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 (Participant)
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 ]
  • Post operative length of stay [ Time Frame: 6 weeks ]
  • Episodes of post-operative vomiting [ Time Frame: 24h ]

Secondary Outcome Measures:
  • Peri-operative complications [ Time Frame: 24h ]
  • Post-operative complications [ Time Frame: 6 weeks ]
  • Anaesthetic time [ Time Frame: 24h ]
  • Operating time [ Time Frame: 24h ]
  • Post-operative pain and analgesia requirements [ Time Frame: 6 weeks ]
  • Cosmetic outcome [ Time Frame: 6 weeks ]
  • Total in-hospital costs [ Time Frame: 6 months ]

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   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All infants with pyloric stenosis

Exclusion Criteria:

  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: 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

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

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 July 19, 2017