Comparative Study of Laparoscopic Versus Open Appendectomy in Children

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Appendicitis

Treatments: Procedure: laparoscopic appendectomy; Procedure: open appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00554008

IRB00002184

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

1

Active Comparator group

Description:

children randomized to open appendectomy

Treatment:

Procedure: open appendectomy

2

Active Comparator group

Description:

children randomized to laparoscopic appendectomy

Treatment:

Procedure: laparoscopic appendectomy