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

First Received on September 2, 2005. Last Updated on June 12, 2008 History of Changes

Sponsor:	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:	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:

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):

Hall NJ, Pacilli M, Eaton S, Reblock K, Gaines BA, Pastor A, Langer JC, Koivusalo AI, Pakarinen MP, Stroedter L, Beyerlein S, Haddad M, Clarke S, Ford H, Pierro A. Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial. Lancet. 2009 Jan 31;373(9661):390-8. Epub 2009 Jan 18.

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 February 09, 2012