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

NCT04830085 | Completed DMC

• 1 other identifier: 2017/22
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenomyosis

Outcome Measures

Primary Outcomes (5)

• Severity of dysmenorrhea measured with Visual Analog Scale

  6 months

• Severity of dyspareunia measured with Visual Analog Scale

  6 months

• Detection of myometrial heterogeneity during transvaginal ultrasonographic examination

  6 months

• Detection of myometrial cysts during transvaginal ultrasonographic examination

  6 months

• Presence of uterine tenderness during pelvic examination

  6 months

Study Arms (2)

Patients with adenomyosis

EXPERIMENTAL

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

Procedure: Hysterectomy

Patients without adenomyosis

ACTIVE COMPARATOR

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

Procedure: Hysterectomy

Interventions

Hysterectomy PROCEDURE

Hysterectomy (abdominal, vaginal or laparoscopic)

Also known as: Histopathological evaluation

Patients with adenomyosis; Patients without adenomyosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Adenomyosis

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• HAKAN AYTAN, Prof. MD

  Mersin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: April 2, 2021
• Study Start: February 10, 2017
• Primary Completion: August 10, 2017
• Study Completion: August 10, 2017
• Last Updated: April 2, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)