Enterobius Vermicularis Infestation of the Appendix

• Sponsor: Al-Azhar University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04576273
• Collaborator: (none)
• Enrollment: 1,150
• Location: 1
• Actual Duration (Months): 36
• Patients Per Site Per Month: 32

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parasitic Disease	Diagnostic Test: Pathology examination

Detailed Description

All the patients undergoing appendectomy surgical procedure for clinical picture of acute appendicitis in 3-years period at our referral hospital were evaluated to pick up the Enterobius vermicularis infestation of the appendix. These cases were evaluated for clinico-laboratory characterization to define the incidence in our country and the relationship between the E.v and initiation of the the inflammatory process to study the possibility of limitation of surgical intervention in acute abdomen conditions.

Study Design

• Study Type: Observational
• Actual Enrollment: 1150 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Enterobius Vermicularis in Appendectomy Specimens; Clinicopathological Assessment
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: May 31, 2020
• Actual Study Completion Date: May 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Non-parasitic	Diagnostic Test: Pathology examination; Gross and microscopic evaluation
Parasitic	Diagnostic Test: Pathology examination; Gross and microscopic evaluation

Outcome Measures

Primary Outcome Measures

1. Association between acute inflammation and Enterobius vermicularis infestation [3 years]

   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

2. Incidence of Appendiceal Enterobius vermicularis [3 years]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 90 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

All routine examined appendectomy specimens

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abdulkarim Hasan	Baljurashi		Saudi Arabia

Sponsors and Collaborators

• Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aabdulkarim Hasan, Lab Director, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT04576273
• Other Study ID Numbers: 3003
• First Posted: Oct 6, 2020
• Last Update Posted: Oct 6, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parasitic Diseases

Study Results

No Results Posted as of Oct 6, 2020