NCT05048745

Brief Summary

COVID-19 infection is a global pandemic that locked down hospitals and made patients fear to consult for medical health problems especially acute abdominal pain. Subsequently, complicated appendicitis namely appendicular abscess in increasing. The best treatment of an appendicular abscess is percutaneous drainage while no studies are dealing with recurrent appendicitis in cases without interval appendectomy during the COVID-19 pandemic. This study aimed to evaluate recurrent appendicitis after successful drainage of appendicular abscess without interval appendectomy during COVID. A prospective cohort study conducted in the surgical emergency units of University Hospitals between 15th March 2020 to 15th August 2020 on 316 patients admitted during the study period with the clinical diagnosis of a successful drained appendicular abscess. (Open or radiological).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
316

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

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

March 15, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

September 8, 2021

Last Update Submit

September 16, 2021

Conditions

Keywords

appendicitis

Outcome Measures

Primary Outcomes (1)

  • recurrence

    incidence of recurrence

    1 year

Interventions

interval appendectomy

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective cohort study conducted in the surgical emergency units of our University Hospitals between 15th March 2020 to 15th August 2020 on 316 patients admitted during the study period with the clinical diagnosis of a successful drained appendicular abscess. (Open or radiological). This study is compliant with the STROCSS criteria

You may qualify if:

  • both sex
  • successful drained appendicular abscess

You may not qualify if:

  • generalized peritonitis
  • pregnancy
  • cases suspected of cancer caecum, inflammatory bowel disease, failure or difficult initial drainage e.g. pelvic abscess, appendectomy performed at the time of drainage, non-cooperative patients for regular follow up and abscess less than 3 cm if showed improvement of clinical and radiological signs within 3 days of antibiotic therapy alone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tamer Alsaied Alnaimy

Zagazig, Sharqia Province, 055, Egypt

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • tamer alnaimy, Phd

    faculty of medicine zagazig university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professour of general and laparoscopic surgery

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 17, 2021

Study Start

March 15, 2020

Primary Completion

August 15, 2020

Study Completion

August 15, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations