Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

NCT ID: NCT00144924

Last Updated: 2022-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-05-31

Brief Summary

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Comparison of open and laparoscopic pyloromyotomy

Detailed Description

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Conditions

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Pyloric Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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laparoscopic pyloromyotomy

Group Type EXPERIMENTAL

laparoscopy pyloromyotomy

Intervention Type PROCEDURE

laparoscopic pyloromyotomy

open pyloromyotomy

Group Type ACTIVE_COMPARATOR

open pyloromytomy

Intervention Type PROCEDURE

open pyloromyotomy

Interventions

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laparoscopy pyloromyotomy

laparoscopic pyloromyotomy

Intervention Type PROCEDURE

open pyloromytomy

open pyloromyotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

0 Months

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Child Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nigel Hall, Mr

Role: PRINCIPAL_INVESTIGATOR

Institute of Child Health

Locations

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Institute of Child Health/Great Ormond Street Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 19155060 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22480835 (View on PubMed)

Other Identifiers

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03SG45

Identifier Type: -

Identifier Source: org_study_id

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