NCT02189668

Brief Summary

To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 17, 2018

Completed
Last Updated

November 27, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

July 3, 2014

Results QC Date

March 15, 2018

Last Update Submit

October 28, 2018

Conditions

Appendicitis

Keywords

AppendicitisNon-operativeChildrenAppendicolithfecalithPediatrics

Outcome Measures

Primary Outcomes (1)

  • Number of Participants That Did Not Have an Appendectomy

    Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge

    1 year

Secondary Outcomes (1)

  • Number of Participants With Complicated Appendicitis

    1 year

Study Arms (2)

Non-operative Management

EXPERIMENTAL

Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic

Drug: Antibiotics only (Zosyn then Augmentin)

Surgery

NO INTERVENTION

Usual care with urgent appendectomy

Interventions

Antibiotics only (Zosyn then Augmentin)DRUG

Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic

Also known as: non operative management
Non-operative Management

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age : 7-17 years
  • Abdominal pain \</= 48hours prior to receiving antibiotics
  • White Blood Cell Count \>5 but \< 18
  • US or CT confirmed early appendicitis plus:
  • US: \</=1.1 cm in diameter, presence of appendicolith
  • CT: \</= 1.1cm in diameter, presence of appendicolith

You may not qualify if:

  • Positive urine pregnancy test
  • Pain \> 48 hours prior to first antibiotic dose
  • Diffuse peritonitis
  • History of chronic intermittent abdominal pain
  • White Blood Cell count ≤ 5 or ≥ 18
  • Absence of appendicolith or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

  • Minneci PC, Sulkowski JP, Nacion KM, Mahida JB, Cooper JN, Moss RL, Deans KJ. Feasibility of a nonoperative management strategy for uncomplicated acute appendicitis in children. J Am Coll Surg. 2014 Aug;219(2):272-9. doi: 10.1016/j.jamcollsurg.2014.02.031. Epub 2014 Apr 13.

    PMID: 24951281BACKGROUND

  • Mahida JB, Lodwick DL, Nacion KM, Sulkowski JP, Leonhart KL, Cooper JN, Ambeba EJ, Deans KJ, Minneci PC. High failure rate of nonoperative management of acute appendicitis with an appendicolith in children. J Pediatr Surg. 2016 Jun;51(6):908-11. doi: 10.1016/j.jpedsurg.2016.02.056. Epub 2016 Mar 2.

    PMID: 27018085RESULT

MeSH Terms

Conditions

AppendicitisFecal Impaction

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesIntestinal Obstruction

Results Point of Contact

Title
Peter Minneci
Organization
Nationwide Children's Hospital
peter.minneci@nationwidechildrens.org
6147223066

Study Officials

  • Peter C Minneci, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 14, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 27, 2018

Results First Posted

April 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)