NCT04576273

Brief Summary

This study identifies the incidence of appendiceal Enterobius vermicularis (E.v) infestation in all the patients undergoing appendectomy and evaluates the relationship between E.v infestation of the appendix and the acute appendicitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,150

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
Last Updated

October 6, 2020

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

September 23, 2020

Last Update Submit

September 29, 2020

Conditions

Parasitic Disease

Outcome Measures

Primary Outcomes (2)

  • Association between acute inflammation and Enterobius vermicularis infestation

    All the studied Enterobius vermicularis cases will be evaluated microscopically to record the count of acute inflammatory cells per millimeter (mm) and per High Power Field (HPF) using the microscope scale measurement. This count will be compared with the inflamed appendectomy specimens without Enterobius infestation to assess the hypothesis of the association between the Enterobius infestation and the acute appendicitis. Also special stain (congo red) will be implicated in some indicated cases to detect eosinophils, eosinophils will be positively staines (orange color stain means positive) if the stain is faint that means negative and the cell is not eosinophil

    3 years

  • Incidence of Appendiceal Enterobius vermicularis

    An incidence of Enterobius infestation will be assessed by studying all the received specimens during a 3 years-period using formatting a master sheet and processing in Excel program

    3 years

Study Arms (2)

Non-parasitic

Diagnostic Test: Pathology examination

Parasitic

Diagnostic Test: Pathology examination

Interventions

Pathology examinationDIAGNOSTIC_TEST

Gross and microscopic evaluation

Non-parasiticParasitic

Eligibility Criteria

Age4 Years - 90 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Saudi and non- Saudi patients suffering from acute appendicitis symptoms

You may qualify if:

  • All routine examined appendectomy specimens

You may not qualify if:

  • Cases with clinical suspicion of tumor Cases attached to the colectomy specimens

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdulkarim Hasan

Baljurashi, Saudi Arabia

Location

MeSH Terms

Conditions

Parasitic Diseases

Condition Hierarchy (Ancestors)

Infections

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lab Director

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 6, 2020

Study Start

June 1, 2017

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

October 6, 2020

Record last verified: 2020-09

Locations

SA(1)