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Comparative Study of Laparoscopic Versus Open Appendectomy in Children

Oregon Health & Science University (OHSU) logo

Oregon Health & Science University (OHSU)

Status

Completed

Conditions

Appendicitis

Treatments

Procedure: open appendectomy
Procedure: laparoscopic 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

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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