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OpenTrials
Completed

NCT Number: NCT00554008

Comparative Study of Laparoscopic Versus Open Appendectomy in Children

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.

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Key information

Conditions

Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laparoscopic appendectomy

Procedure

appendix removal via scope

open appendectomy

Procedure

open operation for removal of appendix

Primary outcomes

  1. Surgical complications, length of stay, pain medication requirements

    Time frame: within 30 days of intervention

Secondary outcomes

  1. Patient/family satisfaction

    Time frame: within 7 days of intervention

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Children's Hospital Los Angeles

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Nov 6, 2007
Registry last updated
May 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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