Study Stopped
The aim was to recruit 200 infants (100 per group); however, the data monitoring and ethics committee recommended halting the trial before full recruitment because of significant treatment benefit in one group at interim analysis.
Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis
Recovery After Open Versus Laparoscopic Pyloromyotomy for Pyloric Stenosis: a Double-blind Multicentre Randomised Controlled Trial
1 other identifier
interventional
180
1 country
1
Brief Summary
Comparison of open and laparoscopic pyloromyotomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2004
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFebruary 17, 2022
February 1, 2022
2.9 years
September 2, 2005
February 1, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Time to full feeds
6 weeks
Post operative length of stay
6 weeks
Episodes of post-operative vomiting
24h
Secondary Outcomes (7)
Peri-operative complications
24h
Post-operative complications
6 weeks
Anaesthetic time
24h
Operating time
24h
Post-operative pain and analgesia requirements
6 weeks
- +2 more secondary outcomes
Study Arms (2)
laparoscopic pyloromyotomy
EXPERIMENTALopen pyloromyotomy
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- clinical diagnosis of infantile hypertrophic pyloric stenosis
You may not qualify if:
- Presence of co-existing congenital or chromosomal abnormality
- The need to perform any additional procedure at the time of pylotomyotomy
- Failure to receive informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Child Health/Great Ormond Street Hospital
London, United Kingdom
Related Publications (2)
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. doi: 10.1016/S0140-6736(09)60006-4. Epub 2009 Jan 18.
PMID: 19155060RESULTCarrington EV, Hall NJ, Pacilli M, Drake DP, Curry JI, Kiely EM, De Coppi P, Pierro A, Eaton S. Cost-effectiveness of laparoscopic versus open pyloromyotomy. J Surg Res. 2012 Nov;178(1):315-20. doi: 10.1016/j.jss.2012.01.031. Epub 2012 Mar 27.
PMID: 22480835DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nigel Hall, Mr
Institute of Child Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 5, 2005
Study Start
June 1, 2004
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
February 17, 2022
Record last verified: 2022-02