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

Sponsor
Mersin University (Other)
Overall Status
Completed
CT.gov ID
NCT04830085
Collaborator
(none)
221
1
2
5.9
37.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hysterectomy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
221 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis
Actual Study Start Date :
Feb 10, 2017
Actual Primary Completion Date :
Aug 10, 2017
Actual Study Completion Date :
Aug 10, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with adenomyosis

Hysterectomy (abdominal or vaginal or laparoscopic) Histopathological assessment Adenomyosis was diagnosed with histopathological assessment.

Procedure: Hysterectomy
Hysterectomy (abdominal, vaginal or laparoscopic)
Other Names:
  • Histopathological evaluation
  • Active Comparator: Patients without adenomyosis

    Hysterectomy (abdominal or vaginal or laparoscopic) Histopathological assessment Adenomyosis was excluded with histopathological assessment.

    Procedure: Hysterectomy
    Hysterectomy (abdominal, vaginal or laparoscopic)
    Other Names:
  • Histopathological evaluation
  • Outcome Measures

    Primary Outcome Measures

    1. Severity of dysmenorrhea measured with Visual Analog Scale [6 months]

    2. Severity of dyspareunia measured with Visual Analog Scale [6 months]

    3. Detection of myometrial heterogeneity during transvaginal ultrasonographic examination [6 months]

    4. Detection of myometrial cysts during transvaginal ultrasonographic examination [6 months]

    5. Presence of uterine tenderness during pelvic examination [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mersin University Mersin Turkey

    Sponsors and Collaborators

    • Mersin University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hakan Aytan, Professor Dr., Mersin University
    ClinicalTrials.gov Identifier:
    NCT04830085
    Other Study ID Numbers:
    • 2017/22
    First Posted:
    Apr 2, 2021
    Last Update Posted:
    Apr 2, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 2, 2021