Clinical trial NCT06142214: Relationship Between Pan Immune Inflammatory Index and Endometriosis
Official title: Pan İmmun İnflamatuar İndeks (PIV) Ile Endometriosiz Arasındaki İlişki
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Relationship Between Pan Immune Inflammatory Index and Endometriosis and Endometriosis Stages
Keywords: endometriosis
endometriosis stages
pan immune inflammatory index
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between the ages of 18-45, who applied to the Gynecology outpatient clinic of Etlik City Hospital and were followed up in our hospital, who were suspected for endometriosis on ultrasound or MRI or CT, and who were operated and whose postoperative pathology was compatible with endometrioma will be included in the study. When we look at the number of operations in our Gynecology Clinic, an average of 3 endometrioma operations are performed per week. Our study period is planned as 6 months and the number of patients is planned as 100. Patients who underwent bilateral tubal ligation in our Gynecology Clinic and who do not have any pelvic pathology will be included as the control group.

Brief summary: The aim of this study was to investigate whether there is a difference in terms of pan immune inflammatory index in patients with and without endometriosis and to investigate whether there is a correlation between the severity of endometriosis and this index in patients with endometriosis. To reveal the importance of the pan immune inflammatory index in predicting the severity of the disease and to contribute to the literature by examining its relationship with a new index in this sense.

Detailed description: Endometrosis is a common estrogen-dependent chronic inflammatory disease that causes pelvic pain and infertility. Its etiology is complex and multifactorial and several theories have been proposed to explain its pathogenesis, which are not fully understood. Endometrial cells are characterized by extensive endometrial implants outside the uterus, especially in the ovaries, ligaments and peritoneal surfaces. These implants lead to inflammation resulting in scar tissue banding, also called endometrial adhesions in advanced stages (III and IV). Endometriosis affects 10-15% of reproductive women and is associated with different symptoms such as infertility, chronic pelvic pain, dyspareunia, dysmenorrhea and abnormal uterine bleeding. The American Society for Reproductive Medicine (ASRM) categorizes it into four stages according to the size of endometriotic implants in the ovaries, peritoneum and fallopian tubes and the severity of adhesion.

Stage I: This is also known as minimal endometriosis. In stage I, superficial implants and mild adhesions may grow outside the uterus. The score for minimal endometriosis is between one and five.

Stage II: This is also known as mild endometriosis. With stage II, implants may be superficial or deep with mild adhesions. In stage II, endometriosis may be widespread and deep implants may be present. Score six to 15 for mild endometriosis between Stage III: This is also known as moderate endometriosis. With stage III deep implants are available. Adhesions may also be thin and dense. As a result, endometriosis is more common than in Stage II. The score for moderate endometriosis is between 16 and 40.

Stage IV: This is also known as severe endometriosis. With stage IV, deep implants and dense adhesions are present. There may be superficial endometriosis and thin adhesions, but the disease is more widespread than in Stage III. Any score greater than 40 indicates severe endometriosis.

The pan-immune inflammatory index (neutrophil count X monocyte count X platelet count/lymphocyte count) is a scoring system of immune inflammatory cells in peripheral blood. Although this index was first studied in malignant diseases, it has been found to be associated with non-malignant diseases in subsequent studies.

In the light of the literature, we aimed to determine the relationship between pan immune inflammatory index and endometriosis and endometriosis stages.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-45
* Patients with suspected endometrosis on ultrasonography or MRI or CT
* Patients with a postoperative pathologic diagnosis of endometrioma
* Patients without pelvic pathology operated for bilateral tubal ligation

Exclusion Criteria:

* Diagnosis or evidence of systemic inflammatory disease
* Having an adnexal mass other than endometriosis
* presence of infectious disease
* Mobite obesity

Primary outcomes:
measure: Diagnosis of endometriosis -Pan Immune Inflammatory Index
timeFrame: Pre-operative
Secondary outcomes:
measure: Stage of endometriosis -Pan Immune Inflammatory Index
timeFrame: Pre-operative
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Yenimahalle
Study officials:
References: