Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

Institute of Child Health

Status: Terminated

Conditions: Pyloric Stenosis

Treatments: Procedure: laparoscopy pyloromyotomy; Procedure: open pyloromytomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00144924

03SG45

Details and patient eligibility

About

Comparison of open and laparoscopic pyloromyotomy

Enrollment: 180 patients

Sex: All

Ages: Under 3 months old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

laparoscopic pyloromyotomy

Experimental group

Treatment:

Procedure: laparoscopy pyloromyotomy

open pyloromyotomy

Active Comparator group

Treatment:

Procedure: open pyloromytomy