NCT02271932

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,076

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

5.1 years

First QC Date

October 20, 2014

Last Update Submit

February 7, 2023

Conditions

Appendicitis

Keywords

appendicitisnon-operative managementchildrenpediatric

Outcome Measures

Primary Outcomes (2)

  • Success rate

    success rate at 1 year is percent of patients choosing non-operative management who have not undergone an appendectomy

    1 year

  • Disability Days

    Number of days without normal schedule

    1 year

Secondary Outcomes (1)

  • Perforated appendicitis

    1 year

Study Arms (2)

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).

Other: Non-operative

Interventions

Non-operativeOTHER

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

Also known as: Non-operative management with antibiotics alone
Non-operative

Eligibility Criteria

Age8 Years - 17 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with uncomplicated appendicitis

You may qualify if:

  • 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

You may not qualify if:

  • History of chronic intermittent abdominal pain
  • Pain \> 48 hours prior to first antibiotic dose
  • Diffuse peritonitis
  • Positive urine pregnancy test
  • White Blood Cell ≤ 5,000/µL or ≥ 18,000/µL
  • Presence of a fecalith on imaging
  • Evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon
  • Communication difficulties (e.g. severe developmental delay)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (6)

  • 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

  • Minneci PC, Mahida JB, Lodwick DL, Sulkowski JP, Nacion KM, Cooper JN, Ambeba EJ, Moss RL, Deans KJ. Effectiveness of Patient Choice in Nonoperative vs Surgical Management of Pediatric Uncomplicated Acute Appendicitis. JAMA Surg. 2016 May 1;151(5):408-15. doi: 10.1001/jamasurg.2015.4534.

    PMID: 26676711BACKGROUND

  • Gonzalez DO, Deans KJ, Minneci PC. Role of non-operative management in pediatric appendicitis. Semin Pediatr Surg. 2016 Aug;25(4):204-7. doi: 10.1053/j.sempedsurg.2016.05.002. Epub 2016 May 10.

    PMID: 27521709BACKGROUND

  • Gil LA, Asti L, Chen HF, Saito JM, Pattisapu P, Deans KJ, Minneci PC; Midwest Pediatric Surgery Consortium. Cost-Effectiveness of Nonoperative Management vs Upfront Laparoscopic Appendectomy for Pediatric Uncomplicated Appendicitis for 1 Year. J Am Coll Surg. 2025 Mar 1;240(3):288-298. doi: 10.1097/XCS.0000000000001232. Epub 2025 Feb 14.

    PMID: 39560281DERIVED

  • Minneci PC, Hade EM, Gil LA, Metzger GA, Saito JM, Mak GZ, Hirschl RB, Gadepalli S, Helmrath MA, Leys CM, Sato TT, Lal DR, Landman MP, Kabre R, Fallat ME, Cooper JN, Deans KJ; Midwest Pediatric Surgery Consortium. Demographic and Clinical Characteristics Associated With the Failure of Nonoperative Management of Uncomplicated Appendicitis in Children: Secondary Analysis of a Nonrandomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e229712. doi: 10.1001/jamanetworkopen.2022.9712.

    PMID: 35499827DERIVED

  • Minneci PC, Hade EM, Lawrence AE, Sebastiao YV, Saito JM, Mak GZ, Fox C, Hirschl RB, Gadepalli S, Helmrath MA, Kohler JE, Leys CM, Sato TT, Lal DR, Landman MP, Kabre R, Fallat ME, Cooper JN, Deans KJ; Midwest Pediatric Surgery Consortium. Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis. JAMA. 2020 Aug 11;324(6):581-593. doi: 10.1001/jama.2020.10888.

    PMID: 32730561DERIVED

MeSH Terms

Conditions

Appendicitis

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery and Pediatrics

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 22, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2019

Study Completion

November 1, 2023

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)