NCT04649996

Brief Summary

retrospective observational study of variation in incidence and clinical presentation of appendicitis during the pandemic in northern Italy, compared with the same period in the previous 2 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
532

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

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

September 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

December 1, 2020

Last Update Submit

December 2, 2020

Conditions

Acute Appendicitis

Outcome Measures

Primary Outcomes (1)

  • complicated appendicitis

    Number of patients with complicated acute appendicitis

    2 months

Study Arms (2)

Pandemic period

patients admitted in hospital for acute appendicitis

Procedure: Appendectomy

control period

patients admitted in hospital for acute appendicitis

Procedure: Appendectomy

Interventions

AppendectomyPROCEDURE

comparison between operative and conservative treatment

Also known as: Conservative treatment
Pandemic periodcontrol period

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted in hospital for acute appendicitis

You may qualify if:

  • acute appendicitis

You may not qualify if:

  • other diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Policlinico San Pietro

Ponte San Pietro, BG, Italy

Location

Ospedale Manzoni

Lecco, LC, Italy

Location

ASST Monza

Monza, MB, 20900, Italy

Location

Ospedale San Raffaele

Milan, Mi, Italy

Location

ASST Lodi

Lodi, Italy

Location

Azienda ospedaliero-universitaria Pisana,Ospedale Cisanello

Pisa, Italy

Location

Related Publications (1)

  • Ceresoli M, Coccolini F, Magnone S, Lucianetti A, Bisagni P, Armao T, Ansaloni L, Zago M, Chiarugi M, Catena F, Braga M; Appendicitis-COVID study group. The decrease of non-complicated acute appendicitis and the negative appendectomy rate during pandemic. Eur J Trauma Emerg Surg. 2021 Oct;47(5):1359-1365. doi: 10.1007/s00068-021-01663-7. Epub 2021 Apr 12.

    PMID: 33844036DERIVED

MeSH Terms

Conditions

Appendicitis

Interventions

AppendectomyConservative Treatment

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 2, 2020

Study Start

September 1, 2020

Primary Completion

October 31, 2020

Study Completion

November 30, 2020

Last Updated

December 4, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(6)