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Comparative Study of Laparoscopic Versus Open Appendectomy in Children

Randomized, Prospective, Single Blinded Trial of Laparoscopic Versus Open Appendectomy in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00554008
Enrollment
400
Registered
2007-11-06
Start date
2007-12-31
Completion date
2011-01-31
Last updated
2012-05-30

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

Conditions

Appendicitis

Keywords

Appendicitis, laparoscopy, randomized trial, children, pediatric

Brief summary

The study intends to compare the results of two surgical methods to remove the appendix in children with appendicitis. Specifically, up to 500 children over 3 years will be placed in two groups where the only difference in treatment is open or laparoscopic (scope) operation. Each group will be tracked for their baseline characteristics, events during operation and recovery, pain medication requirements, duration of hospital stay, and patient/family satisfaction. The investigators hypothesize that their will be no difference in the parameters measured between the techniques of appendix removal.

Interventions

PROCEDURElaparoscopic appendectomy

appendix removal via scope

open operation for removal of appendix

Sponsors

Children's Hospital Los Angeles
CollaboratorOTHER
Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* All children under the age of 18 years with diagnosed appendicitis

Exclusion criteria

* Refusal of consent * Primary language other than English or Spanish.

Design outcomes

Primary

MeasureTime frame
Surgical complications, length of stay, pain medication requirementswithin 30 days of intervention

Secondary

MeasureTime frame
Patient/family satisfactionwithin 7 days of intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026