AdenomyosisNCT04830085
Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis
A study testing Hysterectomy in people with Adenomyosis, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2017to 10 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who were admitted to the hospital with the hysterectomy indications for benign pathologies
Who cannot join
- Patients with postoperative diagnosis of gynecologic malignancies and who were pregnants
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Adenomyosis
- Being tested
- Hysterectomy
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysterectomyProcedure or surgery
Also called Histopathological evaluation
Hysterectomy (abdominal, vaginal or laparoscopic)
| Study group | Role | What they receive |
|---|---|---|
| Patients with adenomyosis | Experimental | Hysterectomy (abdominal or vaginal or laparoscopic) Histopathological assessment Adenomyosis was diagnosed with histopathological assessment. Receives: Procedure: Hysterectomy |
| Patients without adenomyosis | Active comparator | Hysterectomy (abdominal or vaginal or laparoscopic) Histopathological assessment Adenomyosis was excluded with histopathological assessment. Receives: Procedure: Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of dysmenorrhea measured with Visual Analog Scale
Measured: 6 months
Severity of dyspareunia measured with Visual Analog Scale
Measured: 6 months
Detection of myometrial heterogeneity during transvaginal ultrasonographic examination
Measured: 6 months
Detection of myometrial cysts during transvaginal ultrasonographic examination
Measured: 6 months
Presence of uterine tenderness during pelvic examination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start10 Feb 2017
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Aytan, Mersin University
- Investigators
- HAKAN AYTAN, Prof. MD, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830085
- Sponsor's protocol ID
- 2017/22
- Status last verified
- Apr 2021
- First submitted
- 27 Mar 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis
- ClinicalTrials.gov ID
- NCT04830085
- Acronym / sponsor ID
- 2017/22
- Conditions
- Adenomyosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with adenomyosis | Experimental | Procedure: HysterectomyHysterectomy (abdominal or vaginal or laparoscopic) Histopathological assessment Adenomyosis was diagnosed with histopathological assessment. |
| Patients without adenomyosis | Active comparator | Procedure: HysterectomyHysterectomy (abdominal or vaginal or laparoscopic) Histopathological assessment Adenomyosis was excluded with histopathological assessment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who were admitted to the hospital with the hysterectomy indications for benign pathologies
Key exclusion criteria (1 listed)
- Patients with postoperative diagnosis of gynecologic malignancies and who were pregnants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HysterectomyAlso: Histopathological evaluationHysterectomy (abdominal, vaginal or laparoscopic) | Procedure or surgery | Patients with adenomyosis, Patients without adenomyosis |
Primary outcome
Severity of dysmenorrhea measured with Visual Analog Scale
Time frame: 6 months
Severity of dyspareunia measured with Visual Analog Scale
Time frame: 6 months
Detection of myometrial heterogeneity during transvaginal ultrasonographic examination
Time frame: 6 months
Detection of myometrial cysts during transvaginal ultrasonographic examination
Time frame: 6 months
Presence of uterine tenderness during pelvic examination
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Adenomyosis
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Linzagolix in Adenomyosis and Recurrent Implantation Failure
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Recruiting
Stellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HAKAN AYTAN, Prof. MD study director
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysterectomy in people with Adenomyosis, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of dysmenorrhea measured with Visual Analog Scale (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.