Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

N/ATerminatedNCT00144924

Institute of Child Health180 enrolled

Overview

Comparison of open and laparoscopic pyloromyotomy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

180

Conditions

Pyloric Stenosis

Interventions

laparoscopy pyloromyotomyPROCEDURE

laparoscopic pyloromyotomy

open pyloromytomyPROCEDURE

open pyloromyotomy

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 3 Months

Medical Language ↔ Plain English

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

Locations (1)

Institute of Child Health/Great Ormond Street Hospital

London, United Kingdom

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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