Multi-institutional Trial of Non-operative Management of Uncomplicated Pediatric Appendicitis

Status: Unknown
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: f
View:

• English and non-English speaking patients

• Age : 8-17 years

• US or CT confirmed early appendicitis with US showing hyperemia, ≤ 1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon or CT showing hyperemia, fat stranding, ≤ 1.1 cm in diameter, no abscess, no fecalith, no phlegmon

• White Blood Cell count \> 5,000/µL and ≤ 18,000/µL

• Abdominal pain ≤ 48hours prior to receiving antibiotics

Locations
United States
Ohio
Nationwide Children's Hospital
Columbus
Time Frame
Start Date: 2014-10-01
Completion Date: 2023-11-01
Participants
Target number of participants: 1076
Treatments
Surgery
Surgical management with appendectomy consists of hospital admission with initiation of intravenous antibiotics and urgent appendectomy .
Non-operative
Non-operative management consists of hospital admission for observation with a minimum of 24 hours of intravenous antibiotics and a minimum of 12 hours nil per os (NPO). With clinical improvement, patients are switched to oral antibiotics and discharged home with a prescription for oral antibiotics to complete a total antibiotic course of 7 days (including the duration of intravenous antibiotics).
Related Therapeutic Areas
Sponsors
Collaborators: C.S. Mott Children's Hospital, Kosair Children' Hospital, Children's Hospital Medical Center, Cincinnati, American Family Children's Hospital, Comer Children' Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, James Whitcomb Riley Hospital for Children, Children's Hospital and Health System Foundation, Wisconsin, St. Louis Children's Hospital
Leads: Nationwide Children's Hospital

This content was sourced from clinicaltrials.gov