ULTRASONOGRAPHYSonographyNCT04891003
The Identification of Optimal Ultrasonografic Tecniques for Determining the Location , Size and the Surgical Methods of Intestinal Endometriotric Nodules
An observational study of ULTRASONOGRAPHY and Endometriosis, Rectum, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The identification of optimal ultrasonografic tecniques for determining the location , size and the surgical methods of intestinal endometriotric nodules Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- ULTRASONOGRAPHY, Endometriosis, Rectum
- What is being tested?
- Ultrasonography
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2021to 8 May 2021
- Phase
- Observational
- 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 45 years
- Women only
- Adult
Study population: Non- virgin Female Patients having only intestinal findings of deep infiltrative endometriosis aged between 18-45 years old ,
Who may be able to join
- Diagnosed with deep infiltrative endometriosis and intestinal involvement
- Treatment will be done surgically
- Patients should be nonvirgin
Who cannot join
- Patient has one or more extra -intestinal findings of deep infiltrative endometiosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zeynep Kamil Maternity and Childrens Training and Research Hospital
Istanbul, Uskudar, 34668
Resul Karakus, MD, 05059164216, resul-karakus@hotmail.com
About this study
The identification of optimal ultrasonografic tecniques for determining the location , size and the surgical methods of intestinal endometriotric nodules
Read the detailed description
Nulliparous patients who had diagnosed with endometriosis ( endometrioma and/or deep endometriosis) without additional gynecological patology applying for routine gynecological check-up to Zeynep Kamil Training and Research Hospital, Gnecology and Obstetrics Clinic between March 2020 and March 2021 will be included in the study.Inclusion criteria in the study. Inclusion criterias are the presence of endometrioma and/or endometriosis diagnosed with ultrasonographic evaluation, nulliparity,no additional gynecological patology such as myoma uteri, polype, a history of pelvic inflammatuar disease, a history of cervical or uterine surgery, uterine anomalies as well as patients in the control group will be nulliparous and have no gynecological patology including endometrioma and/or endometriosis.All patients will be evaluated in the follicular phase.With the ultrasonographic examination, the uterine version ( anteversion or retroversion) will be evaluated, the length of the uterus (from fundus to cervix on the saggital axis), the anterior-posterior widest uterin length ( at the level of corpus uteri), the cervical length (the distance between the internal os and external os), the cervical anteroposterior length ath the internal os level and the servical canal length at the internal os level, uterocervical angle (the angle between the longitudinal axis of the cervix and the longitudinal axis of the uterine body will be measured three times consecutively , the avarage of the three measurements will be recoreded).with the 90 degree rotation of the probe at the transverse axis the width of the widest corpus level of uterus and the width of the cervix will be measured.Measurements will be made by the same clinician with the same ultrasound device. These measurements and the patients' age, BMI(body mass index), menarche cycle duration, dysmenorrhea, dyspareunia, family history in terms of endometriosis, endometrisosis stage will be recorded.
- Conditions
- ULTRASONOGRAPHY, Endometriosis, Rectum
- Being tested
- Ultrasonography
- Keywords
- Endometriosis, Diagnostic Imaging
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
The identification of optimal ultrasonografic tecniques for determining the location , size and the surgical methods of intestinal endometriotric nodules.
| Study group | Role | What they receive |
|---|---|---|
| Patients Diagnosed with Endometriosis (or endometrioma alone) | Nulliparous patients who had diagnosed with endometriosis, no additional gynecological patology such as myoma uteri, polype, a history of pelvic inflammatuar disease, a history of cervical or uterine surgery, uterine anomalies Receives: Diagnostic Test: Ultrasonography | |
| Patients With No Gynecological Pathology | Nulliparous patients who had not diagnosed with endometriosis, no additional gynecological patology such as myoma uteri, polype, a history of pelvic inflammatuar disease, a history of cervical or uterine surgery, uterine anomalies Receives: Diagnostic Test: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometriosis,intestinal
Ultrrasonographic imaging of endometriosis
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start8 Feb 2021
- Primary completion8 Mar 2021
- Study completion8 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ULTRASONOGRAPHYStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Resul Karakuş, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891003
- Sponsor's protocol ID
- 2020/147
- Acronym
- Sonography
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Identification of Optimal Ultrasonografic Tecniques for Determining the Location , Size and the Surgical Methods of Intestinal Endometriotric Nodules
- ClinicalTrials.gov ID
- NCT04891003
- Acronym / sponsor ID
- Sonography / 2020/147
- Conditions
- ULTRASONOGRAPHY, Endometriosis, Rectum
- Keywords
- Endometriosis, Diagnostic Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 May 2021 (estimated)
- First posted
- 18 May 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.
The identification of optimal ultrasonografic tecniques for determining the location , size and the surgical methods of intestinal endometriotric nodules
Detailed description
Nulliparous patients who had diagnosed with endometriosis ( endometrioma and/or deep endometriosis) without additional gynecological patology applying for routine gynecological check-up to Zeynep Kamil Training and Research Hospital, Gnecology and Obstetrics Clinic between March 2020 and March 2021 will be included in the study.Inclusion criteria in the study. Inclusion criterias are the presence of endometrioma and/or endometriosis diagnosed with ultrasonographic evaluation, nulliparity,no additional gynecological patology such as myoma uteri, polype, a history of pelvic inflammatuar disease, a history of cervical or uterine surgery, uterine anomalies as well as patients in the control group will be nulliparous and have no gynecological patology including endometrioma and/or endometriosis.All patients will be evaluated in the follicular phase.With the ultrasonographic examination, the uterine version ( anteversion or retroversion) will be evaluated, the length of the uterus (from fundus to cervix on the saggital axis), the anterior-posterior widest uterin length ( at the level of corpus uteri), the cervical length (the distance between the internal os and external os), the cervical anteroposterior length ath the internal os level and the servical canal length at the internal os level, uterocervical angle (the angle between the longitudinal axis of the cervix and the longitudinal axis of the uterine body will be measured three times consecutively , the avarage of the three measurements will be recoreded).with the 90 degree rotation of the probe at the transverse axis the width of the widest corpus level of uterus and the width of the cervix will be measured.Measurements will be made by the same clinician with the same ultrasound device. These measurements and the patients' age, BMI(body mass index), menarche cycle duration, dysmenorrhea, dyspareunia, family history in terms of endometriosis, endometrisosis stage will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Diagnosed with Endometriosis (or endometrioma alone) | – | Diagnostic Test: UltrasonographyNulliparous patients who had diagnosed with endometriosis, no additional gynecological patology such as myoma uteri, polype, a history of pelvic inflammatuar disease, a history of cervical or uterine surgery, uterine anomalies |
| Patients With No Gynecological Pathology | – | Diagnostic Test: UltrasonographyNulliparous patients who had not diagnosed with endometriosis, no additional gynecological patology such as myoma uteri, polype, a history of pelvic inflammatuar disease, a history of cervical or uterine surgery, uterine anomalies |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Non- virgin Female Patients having only intestinal findings of deep infiltrative endometriosis aged between 18-45 years old ,
Key inclusion criteria (3 listed)
- Diagnosed with deep infiltrative endometriosis and intestinal involvement
- Treatment will be done surgically
- Patients should be nonvirgin
Key exclusion criteria (1 listed)
- Patient has one or more extra -intestinal findings of deep infiltrative endometiosis
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 |
|---|---|---|
| UltrasonographyThe identification of optimal ultrasonografic tecniques for determining the location , size and the surgical methods of intestinal endometriotric nodules. | Diagnostic test | Patients Diagnosed with Endometriosis (or endometrioma alone), Patients With No Gynecological Pathology |
Primary outcome
Endometriosis,intestinal
Time frame: 4 months
Ultrrasonographic imaging of endometriosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ULTRASONOGRAPHY and Endometriosis, Rectum, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 18 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Resul Karakus, MD (00905059164216, resul-karakus@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometriosis,intestinal (time frame: 4 months). 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 18 May 2021.