Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis | NCT00144924

Studies
Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

NCT00144924

Sponsor

Institute of Child Health

Status

Terminated

Last Update Posted

Feb 17, 2022Actual

Enrollment

180Actual

Phase

Not Applicable

Conditions

Pyloric Stenosis

Interventions

laparoscopy pyloromyotomy
open pyloromytomy

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why 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.

Expanded Access Info

Start Date

Jun 2004Actual

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Sep 2, 2005

First Submission Date that Met QC Criteria

Sep 2, 2005

First Posted Date

Sep 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2022

Last Update Posted Date

Feb 17, 2022Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laparoscopic pyloromyotomy	Experimental		Procedure: laparoscopy pyloromyotomy
open pyloromyotomy	Active Comparator		Procedure: open pyloromytomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laparoscopy pyloromyotomy	Procedure	laparoscopic pyloromyotomy	laparoscopic pyloromyotomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to full feeds		6 weeks
Post operative length of stay		6 weeks
Episodes of post-operative vomiting		24h

Secondary Outcomes

Measure	Description	Time Frame
Peri-operative complications		24h
Post-operative complications		6 weeks
Anaesthetic time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of infantile hypertrophic pyloric stenosis

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Months

Maximum Age

3 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nigel Hall, Mr	Institute of Child Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Child Health/Great Ormond Street Hospital		London			United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19155060	Result	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.
22480835

ID	Term
D017219	Gastric Outlet Obstruction
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases