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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06298617
• Other study ID #: RC 27.1.2024
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: December 25, 2023

Study information

• Verified date: March 2024
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 25, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

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Blood samples withdrawn from patients on EDITA tubes and gone through full blood count and differential leucocytic count

Locations

Country	Name	City	State
Egypt	Benha University	Banha	Al Qalyobia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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