Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

Recovery After Open Versus Laparoscopic Pyloromyotomy for Pyloric Stenosis: a Double-blind Multicentre Randomised Controlled Trial

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00144924

Enrollment

180

Registered

2005-09-05

Start date

2004-06-30

Completion date

2007-05-31

Last updated

2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pyloric Stenosis

Brief summary

Comparison of open and laparoscopic pyloromyotomy

Interventions

PROCEDURElaparoscopy pyloromyotomy

laparoscopic pyloromyotomy

PROCEDUREopen pyloromytomy

open pyloromyotomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

0 Months to 3 Months

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Operating time	24h
Post-operative pain and analgesia requirements	6 weeks
Peri-operative complications	24h
Total in-hospital costs	6 months
Cosmetic outcome	6 weeks
Post-operative complications	6 weeks
Anaesthetic time	24h

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026