Comparative Study of Laparoscopic Versus Open Appendectomy in Children

Not Applicable

Completed

• Conditions: Appendicitis
• Interventions: Procedure: open appendectomy; Procedure: laparoscopic appendectomy

• Registration Number: NCT00554008
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-06
• Study Start: 2007-12
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-25
• Last Update Posted: 2012-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	open appendectomy	children randomized to open appendectomy
2	laparoscopic appendectomy	children randomized to laparoscopic appendectomy

Primary Outcome Measures

Name	Time	Method
Surgical complications, length of stay, pain medication requirements	within 30 days of intervention

Secondary Outcome Measures

Name	Time	Method
Patient/family satisfaction	within 7 days of intervention

Trial Locations

Locations (3)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Emanuel Children's Hospital; 🇺🇸 Portland, Oregon, United States

Oregon Health and Sciences University; 🇺🇸 Portland, Oregon, United States