Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis

Pyloric Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00144924
• Other study ID #: 03SG45
• Status: Terminated
• Phase: N/A
• Start date: June 2004
• Est. completion date: May 2007

Study information

• Verified date: February 2022
• Source: Institute of Child Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of open and laparoscopic pyloromyotomy

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 180
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Procedure:
• laparoscopy pyloromyotomy
laparoscopic pyloromyotomy
• open pyloromytomy
open pyloromyotomy

Locations

Country	Name	City	State
United Kingdom	Institute of Child Health/Great Ormond Street Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Child Health

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to full feeds		6 weeks
Primary	Post operative length of stay		6 weeks
Primary	Episodes of post-operative vomiting		24h
Secondary	Peri-operative complications		24h
Secondary	Post-operative complications		6 weeks
Secondary	Anaesthetic time		24h
Secondary	Operating time		24h
Secondary	Post-operative pain and analgesia requirements		6 weeks
Secondary	Cosmetic outcome		6 weeks
Secondary	Total in-hospital costs		6 months