Pyloric StenosisNCT00144924
Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis
A study testing laparoscopy pyloromyotomy and open pyloromytomy in people with Pyloric Stenosis, run by Institute of Child Health at 1 site in United Kingdom.
Trial summary
Comparison of open and laparoscopic pyloromyotomy Read more about this study
- Who is it for?
- Ages 0 to 3 months
- Conditions the study is for
- Pyloric Stenosis
- What is being tested?
- laparoscopy pyloromyotomy and open pyloromytomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2004to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinical diagnosis of infantile hypertrophic pyloric stenosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Child Health/Great Ormond Street Hospital
London
About this study
Official title: Recovery After Open Versus Laparoscopic Pyloromyotomy for Pyloric Stenosis: a Double-blind Multicentre Randomised Controlled Trial
Comparison of open and laparoscopic pyloromyotomy
- Conditions
- Pyloric Stenosis
- Being tested
- laparoscopy pyloromyotomy, open pyloromytomy
- Medical subject headings
- Pyloric Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopy pyloromyotomyProcedure or surgery
laparoscopic pyloromyotomy
open pyloromytomyProcedure or surgery
open pyloromyotomy
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic pyloromyotomy | Experimental | Not described Receives: Procedure: laparoscopy pyloromyotomy |
| open pyloromyotomy | Active comparator | Not described Receives: Procedure: open pyloromytomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to full feeds
Measured: 6 weeks
Post operative length of stay
Measured: 6 weeks
Episodes of post-operative vomiting
Measured: 24h
Secondary outcomes (7)
Peri-operative complications
Measured: 24h
Post-operative complications
Measured: 6 weeks
Anaesthetic time
Measured: 24h
Operating time
Measured: 24h
Post-operative pain and analgesia requirements
Measured: 6 weeks
Cosmetic outcome
Measured: 6 weeks
Total in-hospital costs
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionMay 2007
- Study completionMay 2007
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pyloric StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nigel Hall, Mr, Principal investigator, Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144924
- Sponsor's protocol ID
- 03SG45
- Status last verified
- Feb 2022
- First submitted
- 2 Sep 2005
- Last updated
- 17 Feb 2022
- Results posted
- No
Publications
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.
PubMed 19155060Carrington 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.
PubMed 22480835
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery After Open Versus Laparoscopic Pyloromyotomy for Pyloric Stenosis: a Double-blind Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00144924
- Acronym / sponsor ID
- 03SG45
- Conditions
- Pyloric Stenosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- Jun 2004 (actual)
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of open and laparoscopic pyloromyotomy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic pyloromyotomy | Experimental | Procedure: laparoscopy pyloromyotomy |
| open pyloromyotomy | Active comparator | Procedure: open pyloromytomy |
Who may qualify
- Ages
- 0 to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- clinical diagnosis of infantile hypertrophic pyloric stenosis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopy pyloromyotomylaparoscopic pyloromyotomy | Procedure or surgery | laparoscopic pyloromyotomy |
| open pyloromytomyopen pyloromyotomy | Procedure or surgery | open pyloromyotomy |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Results publication: PubMed 19155060Hall 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.
- Derived from this study: PubMed 22480835Carrington 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nigel Hall, Mr principal investigator
Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopy pyloromyotomy and open pyloromytomy in people with Pyloric Stenosis, run by Institute of Child Health at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to full feeds (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144924, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.