Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis

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Brief Title

Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis

Official Title

Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis

Brief Summary

      Adenomyosis is a relatively common benign disorder in which endometrial gland and stroma are
      located within the myometrium resulting angiogenesis of the spiral vessel, hypertrophy of the
      surrounding smooth muscles and enlargement of the uterus. So far the definitive diagnosis
      still requires histologic analysis of the hysterectomy specimens or hysteroscopic or
      laparoscopic biopsy. There is no specific laboratory tests and reliable clinical standards
      for the diagnosis. The preoperative diagnosis of adenomyosis, would prevent unnecessary
      therapies, loss of time and use of resources in vain. Therefore precise prediction of this
      disease without surgery gains importance. Developing a scoring system with clinical
      evaluation for this purpose will be very helpful in solving this problem. From this point,
      the investigators aimed to develop a scoring system that will predict presence of adenomyosis
      wİth high sensitivity using clinical evaluation methods such as history, physical
      examination, ultrasonography and laboratory tests. A prospective cohort study was conducted
      with 221 patients. In the study, the investigators have created a clinical scoring system for
      this purpose for the first time in the literature. In this scoring system, there are simple
      parameters that can be easily used by the clinician, have a low cost and are repeatable. The
      effect of each parameter on predicting adenomyosis is different, and the total effect can be
      calculated according to the answer to be given to all questions. In this simple scoring
      system, parity, menarche, VAS scores of dysmenorrhea and dyspareunia, myometrial
      heterogeneity in ultrasonography and presence of tenderness during pelvic examination were
      found to be useful parameters in predicting the diagnosis of adenomyosis.
    

Detailed Description

      A prospective cohort study was conducted in Mersin University Faculty of Medicine Department
      of Obstetrics and Gynecology between 10.02.2017 and 10.08.2017 with 221 patients who had
      undergone hysterectomy for benign disorders. The patients who were admitted to the hospital
      with the hysterectomy indications for benign pathologies were visited before the operation
      and a detailed anamnesis was obtained. Physical and pelvic examinations with transvaginal
      ultrasound examinations were performed by the same investigator. Demographic characteristics,
      obstetric and gynecologic histories were noted. The amount of percieved pain was measured
      with Visual Analog Scale (VAS). Observing myometrial cysts, enlarged uterus, heterogeneous
      myometrium and or focal nodular areas during transvaginal sonography was considered to
      suggest adenomyosis. The hysterectomy specimes were evaluated by department of pathology. The
      diagnosis of adenomyosis was based on the presence of glandular extension ≥2.5 mm below the
      endometrial myometrial interface.

      In order to develop a scoring system a regression analysis was carried out to find the
      parameters that were associated with the presence of adenomyosis. Number of parities,
      dyspareunia and dysmenorrhea VAS scores, age of menarche, presence of uterine tenderness and
      detection of heterogenous myometrium and myometrial cysts during ultrasonography were found
      to be the significant parameters.
    


Study Type

Interventional


Primary Outcome

Severity of dysmenorrhea measured with Visual Analog Scale


Condition

Adenomyosis

Intervention

Hysterectomy

Study Arms / Comparison Groups

 Patients with adenomyosis
Description:  Hysterectomy (abdominal or vaginal or laparoscopic) Histopathological assessment Adenomyosis was diagnosed with histopathological assessment.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

221

Start Date

February 10, 2017

Completion Date

August 10, 2017

Primary Completion Date

August 10, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  The patients who were admitted to the hospital with the hysterectomy indications for
             benign pathologies

        Exclusion Criteria:

          -  Patients with postoperative diagnosis of gynecologic malignancies and who were
             pregnants
      

Gender

Female

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

HAKAN AYTAN, Prof. MD, , 

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT04830085

Organization ID

2017/22


Responsible Party

Principal Investigator

Study Sponsor

Mersin University


Study Sponsor

HAKAN AYTAN, Prof. MD, Study Director, Mersin University


Verification Date

April 2021