Back to results

Non-operative Management of Pediatric Appendicitis With an Appendicoltih

Primary Purpose

Appendicitis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Antibiotics only (Zosyn then Augmentin)

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring Appendicitis, Non-operative, Children, Appendicolith, fecalith, Pediatrics

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Non-operative Management

Surgery

Arm Description

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

Usual care with urgent appendectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Complicated Appendicitis

Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.

Full Information

NCT ID

NCT02189668

First Posted

July 3, 2014

Last Updated

October 28, 2018

Sponsor

Peter Minneci

1. Study Identification

Unique Protocol Identification Number

NCT02189668

Brief Title

Non-operative Management of Pediatric Appendicitis With an Appendicoltih

Official Title

Non-operative Management of Uncomplicated Appendicitis With an Appendicolth in Children

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Terminated

Why Stopped

High failure rate

Study Start Date

July 2014 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Peter Minneci

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Appendicitis

Keywords

Appendicitis, Non-operative, Children, Appendicolith, fecalith, Pediatrics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-operative Management

Arm Type

Experimental

Arm Description

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

Arm Title

Surgery

Arm Type

No Intervention

Arm Description

Usual care with urgent appendectomy

Intervention Type

Drug

Intervention Name(s)

Antibiotics only (Zosyn then Augmentin)

Other Intervention Name(s)

non operative management

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants That Did Not Have an Appendectomy

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Number of Participants With Complicated Appendicitis

Description

Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter C Minneci, MD

Organizational Affiliation

Nationwide Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nationwide Children's Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24951281

Citation

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.

Results Reference

background

PubMed Identifier

27018085

Citation

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.

Results Reference

result

Learn more about this trial

Non-operative Management of Pediatric Appendicitis With an Appendicoltih

We'll reach out to this number within 24 hrs