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Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

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ClinicalTrials.gov Identifier: NCT00144924
Recruitment Status : Unknown
Verified June 2008 by Institute of Child Health.
Recruitment status was:  Recruiting
First Posted : September 5, 2005
Last Update Posted : June 13, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
Comparison of open and laparoscopic pyloromyotomy

Condition or disease Intervention/treatment
Pyloric Stenosis Procedure: pyloromyotomy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Study Start Date : June 2004
Estimated Primary Completion Date : August 2008
Estimated Study Completion Date : August 2008
Arms and Interventions

Intervention Details:
    Procedure: pyloromyotomy
    laparoscopic pyloromytomy

Outcome Measures

Primary Outcome Measures :
  1. Time to full feeds [ Time Frame: 6 weeks ]
  2. Post operative length of stay [ Time Frame: 6 weeks ]
  3. Episodes of post-operative vomiting [ Time Frame: 24h ]

Secondary Outcome Measures :
  1. Peri-operative complications [ Time Frame: 24h ]
  2. Post-operative complications [ Time Frame: 6 weeks ]
  3. Anaesthetic time [ Time Frame: 24h ]
  4. Operating time [ Time Frame: 24h ]
  5. Post-operative pain and analgesia requirements [ Time Frame: 6 weeks ]
  6. Cosmetic outcome [ Time Frame: 6 weeks ]
  7. Total in-hospital costs [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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 ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: June 13, 2008
Last Verified: June 2008

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