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Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

Primary Purpose

Pyloric Stenosis

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
laparoscopy pyloromyotomy
open pyloromytomy
Sponsored by
Institute of Child Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pyloric Stenosis

Eligibility Criteria

0 Months - 3 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Child Health/Great Ormond Street Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

laparoscopic pyloromyotomy

open pyloromyotomy

Arm Description

Outcomes

Primary Outcome Measures

Time to full feeds
Post operative length of stay
Episodes of post-operative vomiting

Secondary Outcome Measures

Peri-operative complications
Post-operative complications
Anaesthetic time
Operating time
Post-operative pain and analgesia requirements
Cosmetic outcome
Total in-hospital costs

Full Information

First Posted
September 2, 2005
Last Updated
February 1, 2022
Sponsor
Institute of Child Health
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1. Study Identification

Unique Protocol Identification Number
NCT00144924
Brief Title
Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis
Official Title
Recovery After Open Versus Laparoscopic Pyloromyotomy for Pyloric Stenosis: a Double-blind Multicentre Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
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.
Study Start Date
June 2004 (Actual)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Child Health

4. Oversight

5. Study Description

Brief Summary
Comparison of open and laparoscopic pyloromyotomy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyloric Stenosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic pyloromyotomy
Arm Type
Experimental
Arm Title
open pyloromyotomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
laparoscopy pyloromyotomy
Intervention Description
laparoscopic pyloromyotomy
Intervention Type
Procedure
Intervention Name(s)
open pyloromytomy
Intervention Description
open pyloromyotomy
Primary Outcome Measure Information:
Title
Time to full feeds
Time Frame
6 weeks
Title
Post operative length of stay
Time Frame
6 weeks
Title
Episodes of post-operative vomiting
Time Frame
24h
Secondary Outcome Measure Information:
Title
Peri-operative complications
Time Frame
24h
Title
Post-operative complications
Time Frame
6 weeks
Title
Anaesthetic time
Time Frame
24h
Title
Operating time
Time Frame
24h
Title
Post-operative pain and analgesia requirements
Time Frame
6 weeks
Title
Cosmetic outcome
Time Frame
6 weeks
Title
Total in-hospital costs
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel Hall, Mr
Organizational Affiliation
Institute of Child Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Child Health/Great Ormond Street Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19155060
Citation
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.
Results Reference
result
PubMed Identifier
22480835
Citation
Carrington 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.
Results Reference
derived

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Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

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