Appendectomy Versus Non-Operative Treatment For Acute Non-Perforated Appendicitis in Children

NACompletedINTERVENTIONAL
Enrollment

978

Participants

Timeline

Start Date

January 20, 2016

Primary Completion Date

March 2, 2023

Study Completion Date

March 2, 2023

Conditions
Appendicitis
Interventions
OTHER

Non-operative treatment

"will receive a minimum of 12 hours intravenous antibiotics and then receive oral antibiotics once they have shown clinical improvement (a total course of 10 days of antibiotics (intravenous and oral). They will be discharged home once they meet a standardized set of criteria to be used in all centers.~The choice of antibiotics will vary between centers and will be the antibiotic regimen that is current standard of care in that center allowing each center to maintain current protocols will improve study feasibility and increase generalization of the results."

PROCEDURE

Appendectomy

"will undergo laparoscopic appendectomy within 18 hours of randomization and will receive intravenous antibiotics per each site's standard care, from the time of randomization and post-operatively according to a defined and standardized treatment regimen based on consensus for this trial.~Children with a visibly normal appendix or non-perforated acute appendicitis will receive no further antibiotics; children with perforated appendicitis will continue to receive intravenous antibiotics for a minimum of 3 days, and then per local practice. The type of antibiotics used in each center will be identical to those used in the non-operative treatment group and are not specified by the study."

Trial Locations (1)

64108

Children's Mercy Kansas City, Kansas City

All Listed Sponsors
collaborator

Provincial Health Services Authority

OTHER

collaborator

Alberta Children's Hospital

OTHER

collaborator

Children's Hospital of Western Ontario

OTHER

collaborator

St. Justine's Hospital

OTHER

collaborator

Children's Hospital of Winnipeg

UNKNOWN

collaborator

Le Bonheur Children's Hospital

OTHER

collaborator

Karolinska University Hospital

OTHER

collaborator

Hospital for Children and Adolescents, Finland

OTHER

collaborator

University of Southampton

OTHER

collaborator

UCL Institute of Child Health

UNKNOWN

collaborator

KK Women's and Children's Hospital

OTHER_GOV

collaborator

Uppsala University Children's Hospital

UNKNOWN

lead

Children's Mercy Hospital Kansas City

OTHER

NCT02687464 - Appendectomy Versus Non-Operative Treatment For Acute Non-Perforated Appendicitis in Children | Biotech Hunter | Biotech Hunter