Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis
Primary Purpose
Adenomyosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hysterectomy
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenomyosis
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
Sites / Locations
- Mersin University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with adenomyosis
Patients without adenomyosis
Arm Description
Hysterectomy (abdominal or vaginal or laparoscopic) Histopathological assessment Adenomyosis was diagnosed with histopathological assessment.
Hysterectomy (abdominal or vaginal or laparoscopic) Histopathological assessment Adenomyosis was excluded with histopathological assessment.
Outcomes
Primary Outcome Measures
Severity of dysmenorrhea measured with Visual Analog Scale
Severity of dyspareunia measured with Visual Analog Scale
Detection of myometrial heterogeneity during transvaginal ultrasonographic examination
Detection of myometrial cysts during transvaginal ultrasonographic examination
Presence of uterine tenderness during pelvic examination
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04830085
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
August 10, 2017 (Actual)
Study Completion Date
August 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomyosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with adenomyosis
Arm Type
Experimental
Arm Description
Hysterectomy (abdominal or vaginal or laparoscopic) Histopathological assessment Adenomyosis was diagnosed with histopathological assessment.
Arm Title
Patients without adenomyosis
Arm Type
Active Comparator
Arm Description
Hysterectomy (abdominal or vaginal or laparoscopic) Histopathological assessment Adenomyosis was excluded with histopathological assessment.
Intervention Type
Procedure
Intervention Name(s)
Hysterectomy
Other Intervention Name(s)
Histopathological evaluation
Intervention Description
Hysterectomy (abdominal, vaginal or laparoscopic)
Primary Outcome Measure Information:
Title
Severity of dysmenorrhea measured with Visual Analog Scale
Time Frame
6 months
Title
Severity of dyspareunia measured with Visual Analog Scale
Time Frame
6 months
Title
Detection of myometrial heterogeneity during transvaginal ultrasonographic examination
Time Frame
6 months
Title
Detection of myometrial cysts during transvaginal ultrasonographic examination
Time Frame
6 months
Title
Presence of uterine tenderness during pelvic examination
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HAKAN AYTAN, Prof. MD
Organizational Affiliation
Mersin University
Official's Role
Study Director
Facility Information:
Facility Name
Mersin University
City
Mersin
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis
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