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Completed

NCT Number: NCT06298617

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

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 .

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Key information

Conditions

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

Age range

25 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Benha University

Banhā, Al Qalyobia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic laparoscopy

Procedure

All women will undergo exploratory laparoscopy under general anesthesia

Full Blood Count (FBC)

Diagnostic Test

Blood samples withdrawn from patients on EDITA tubes and gone through full blood count and differential leucocytic count

Primary outcomes

  1. Indices' ability to predict EM stage

    Time frame: 8 months

    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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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