Systemic Inflammatory Indices as a Non-invasive Grading Modality for Endometriosis

Systemic Inflammatory Indices as a Non-invasive Grading Modality for Endometriosis: A Comparative Study Versus Exploratory Laparoscopy

Endometriosis (EMs) is one of the commonest chronic inflammatory disorder affecting women and is characterized by the presence and growth of endometrial-like glandular epithelial and stromal cells outside the uterus leading to multiple clinical symptoms affecting patients quality of life and fertility with high recurrence rate . The systemic immune inflammatory index (SII) and systemic inflammatory response index (SIRI) are documented as prognostic serum biomarker in many kinds of cancer and for the need and outcomes of adjuvant therapies for various cancers .

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Procedure: Diagnostic laparoscopy; Diagnostic test: Full Blood Count (FBC)

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Egypt
  • Al Qalyobia
    • Banhā, Al Qalyobia, Egypt, 13511
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All women attending the outpatient of Gynecology department with clinical picture suggestive of having EM or had previously diagnosed depending on radiologic workup were evaluated for the enrolment criteria.

Description

Inclusion Criteria:

• Women with clinical manifestations suggestive of having EM;
• Women who was professionally diagnosed;
• Women who was diagnosed by radiologic workup;
• Women were free of exclusion criteria.

Exclusion Criteria:

• Women with EM and were maintained on treatment or underwent operative interference during the last three months;
• Patients had autoimmune diseases, maintained on immunosuppressive therapy for any indication;
• Women with cancer elsewhere in the body or receiving adjuvant therapies for cancer;
• Patients receiving therapies for viral disorders especially COVID;
• Patients refusing to undergo the exploratory laparoscopy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group	Procedure: Diagnostic laparoscopy; All women will undergo exploratory laparoscopy under general anesthesia; Diagnostic test: Full Blood Count (FBC); Blood samples withdrawn from patients on EDITA tubes and gone through full blood count and differential leucocytic count

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indices' ability to predict EM stage	Number of patients was diagnosed with EM and got staged right through a calculated indices to the patients who went for exploratory laparoscopy which improve the chances of calculated indices facing the laparoscopy.	8 months

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): December 25, 2023

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: RC 27.1.2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No