Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

Not Applicable

Terminated

• Conditions: Pyloric Stenosis
• Interventions: Procedure: laparoscopy pyloromyotomy; Procedure: open pyloromytomy

• Registration Number: NCT00144924
• Lead Sponsor: Institute of Child Health

Brief Summary

Comparison of open and laparoscopic pyloromyotomy

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic pyloromyotomy	laparoscopy pyloromyotomy	-
open pyloromyotomy	open pyloromytomy	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Child Health/Great Ormond Street Hospital; 🇬🇧 London, United Kingdom