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

NCT06298617 | Completed

• 1 other identifier: RC 27.1.2024
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study group

Procedure: Diagnostic laparoscopy; Diagnostic Test: Full Blood Count (FBC)

Interventions

Diagnostic laparoscopy PROCEDURE

All women will undergo exploratory laparoscopy under general anesthesia

Study group

Full Blood Count (FBC) DIAGNOSTIC_TEST

Blood samples withdrawn from patients on EDITA tubes and gone through full blood count and differential leucocytic count

Study group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Women with clinical manifestations suggestive of having EM;
• Women who was professionally diagnosed;
• Women who was diagnosed by radiologic workup;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Al Qalyobia, 13511, Egypt

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Laparoscopy; Blood Cell Count

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics & Gynecology Department, Faculty of Medicine.

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: January 1, 2023
• Primary Completion: July 30, 2023
• Study Completion: December 25, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

EG (1)