Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis - Full Text View

Sponsored by:	Institute of Child Health
Information provided by:	Institute of Child Health
ClinicalTrials.gov Identifier:	NCT00144924

Purpose

Comparison of open and laparoscopic pyloromyotomy

Condition	Intervention
Pyloric Stenosis	Procedure: pyloromyotomy

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Subject), Active Control, Parallel Assignment

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:

laparoscopic pyloromytomy

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

-

Contacts and Locations

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

Contacts

Contact: Nigel Hall, Mr

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

Responsible Party:	Institute of Child Health ( R&D Office )
Study ID Numbers:	03SG45
Study First Received:	September 2, 2005
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00144924
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Pyloric Stenosis
Digestive System Diseases
Stomach Diseases

Gastrointestinal Diseases
Constriction, Pathologic
Gastric Outlet Obstruction

ClinicalTrials.gov processed this record on January 16, 2009