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Multi-institutional Trial of Non-operative Management of Appendicitis

NCT02271932 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1076

Last updated 2023-02-09

No results posted yet for this study

Summary

A successful non-operative management strategy for early appendicitis will decrease the number of children requiring surgery and may improve the quality of care related to the treatment of appendicitis. To account for the child-family perspective and treatment preferences, the investigators will perform a study in which patients and their families choose between antibiotics alone (Non-operative group) or appendectomy (Surgery group) at ten U.S. hospitals. This study will determine the effectiveness of non-operative management of early appendicitis with antibiotics alone in children and compare differences in morbidity, disability, quality of life, satisfaction, and cost between families choosing surgery or non-operative management.

Conditions

  • Appendicitis

Interventions

OTHER

Non-operative

Patients will receive only antibiotics and will not undergo appendectomy unless they do not improve or their appendicitis recurs

Sponsors & Collaborators

  • Children's Hospital and Health System Foundation, Wisconsin

    collaborator OTHER

  • Comer Children' Hospital

    collaborator UNKNOWN

  • C.S. Mott Children's Hospital

    collaborator OTHER

  • James Whitcomb Riley Hospital for Children

    collaborator OTHER

  • Kosair Children' Hospital

    collaborator UNKNOWN

  • Ann & Robert H Lurie Children's Hospital of Chicago

    collaborator OTHER

  • St. Louis Children's Hospital

    collaborator OTHER

  • American Family Children's Hospital

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Nationwide Children's Hospital

    lead OTHER

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-01
Primary Completion
2019-11-01
Completion
2023-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02271932 on ClinicalTrials.gov