Uterine Vein Injury LeftNCT06520969
Prevelance of Uterine Vein and Uterine Vein System Variations
A study testing Prevelance of Uterine Vein and Uterine Vein System Variations (anatomical study) in people with Uterine Vein Injury Left and Uterine Vein Injury Right, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Contrary to the uterine arterial system, our knowledge about superficial and deep uterine vein prevalence and anatomic variations are limited. The present study aims to deepen and clarify our knowledge on superficial and deep uterine vein anatomy, prevalence and relationship with other neighbouring structures which… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Vein Injury Left, Uterine Vein Injury Right
- What is being tested?
- Prevelance of Uterine Vein and Uterine Vein System Variations (anatomical study)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2024to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Endometrium and cervical cancer patients that will be operated -
Who cannot join
- Any women in whom uterine vascular anatomy that might be changed for a specific disease such as myomas, uterine infections, etc.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Medical Faculty Dept. of Obstet Gynecol, Division of Gynecologic Oncology
Istanbul, Istanbul / Turkey, 34093
Mustafa ALBAYRAK, MD, +905326871051, mustafaalbayrak@icloud.com
Yagmur MINARECI, MD, +905053574361, yagmurminareci@gmail.com
About this study
Contrary to the uterine arterial system, our knowledge about superficial and deep uterine vein prevalence and anatomic variations are limited. The present study aims to deepen and clarify our knowledge on superficial and deep uterine vein anatomy, prevalence and relationship with other neighbouring structures which may be helpful in uterine transplantation and radical hysterectomy operations.
Read the detailed description
Despite that two veins draining the uterus, superficial and deep, are described, their true anatomy, number, calibers, trajectories, relationships with sympathetic and parasympathetic nerves and internal iliac vasculature and ureters are quite limited. Additionally, variations of these vasculature are much less described. The aim of this study is to increase the our current knowledge about these anatomical information and also to calculate the prevalence of superficial and deep uterine veins which may potentially decrease the possible complications such as bleeding in uterine transplantation surgery and nerve sparing radical hysterectomy for cervical cancer.
- Being tested
- Prevelance of Uterine Vein and Uterine Vein System Variations (anatomical study)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevelance of Uterine Vein and Uterine Vein System Variations (anatomical study)Other
Also called Single arm anatomical study describing the prevalance and anatomical variations of superficial and deep veins in endometrial and cervical cancer patients
Single arm anatomical study describing the prevalance and anatomical variations of superficial and deep veins in endometrial and cervical cancer patients
| Study group | Role | What they receive |
|---|---|---|
| prevalance and anatomical variations of superficial and deep veins | Other | Single arm anatomical study describing the prevalance and anatomical variations of superficial and deep veins in endometrial and cervical cancer patients Receives: Other: Prevelance of Uterine Vein and Uterine Vein System Variations (anatomical study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the prevalence of uterine vein and uterine vein system variations
To describe the prevalence of uterine vein and uterine vein system variations
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start30 Mar 2024
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Vein Injury LeftStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Endometrium and cervical cancer patients that will be operated in Istanbul University School of Medicine, Dept. of Obstetrics and Gynecology, Division of Oncology will be included. Anatomic details such as the presence, number of superficial and deep uterine veins, calibers, anatomical relationships with hypogastric arteries and veins, ureters, vesicouterine ligaments will be described systematically and bilaterally for every consenting women after pelvic spaces are opened before pelvic lypmhadenectomy and hysterectomy. All regarding information will be photographed for every patient bilaterally and recorded on data sheet.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Albayrak, Istanbul University
- Investigators
- Samet Topuz, MD, Study director, Istanbul Univrsity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520969
- Sponsor's protocol ID
- 2248661
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all information stated in this document is open to to third parties whitout any limitations
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevelance of Uterine Vein and Uterine Vein System Variations
- ClinicalTrials.gov ID
- NCT06520969
- Acronym / sponsor ID
- 2248661
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 25 Jul 2024 (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.
Contrary to the uterine arterial system, our knowledge about superficial and deep uterine vein prevalence and anatomic variations are limited. The present study aims to deepen and clarify our knowledge on superficial and deep uterine vein anatomy, prevalence and relationship with other neighbouring structures which may be helpful in uterine transplantation and radical hysterectomy operations.
Detailed description
Despite that two veins draining the uterus, superficial and deep, are described, their true anatomy, number, calibers, trajectories, relationships with sympathetic and parasympathetic nerves and internal iliac vasculature and ureters are quite limited. Additionally, variations of these vasculature are much less described. The aim of this study is to increase the our current knowledge about these anatomical information and also to calculate the prevalence of superficial and deep uterine veins which may potentially decrease the possible complications such as bleeding in uterine transplantation surgery and nerve sparing radical hysterectomy for cervical cancer.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Endometrium and cervical cancer patients that will be operated in Istanbul University School of Medicine, Dept. of Obstetrics and Gynecology, Division of Oncology will be included. Anatomic details such as the presence, number of superficial and deep uterine veins, calibers, anatomical relationships with hypogastric arteries and veins, ureters, vesicouterine ligaments will be described systematically and bilaterally for every consenting women after pelvic spaces are opened before pelvic lypmhadenectomy and hysterectomy. All regarding information will be photographed for every patient bilaterally and recorded on data sheet.
| Arm | Type | Receives |
|---|---|---|
| prevalance and anatomical variations of superficial and deep veins | Other | Other: Prevelance of Uterine Vein and Uterine Vein System Variations (anatomical study)Single arm anatomical study describing the prevalance and anatomical variations of superficial and deep veins in endometrial and cervical cancer patients |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Endometrium and cervical cancer patients that will be operated -
Key exclusion criteria (2 listed)
- Any women in whom uterine vascular anatomy that might be changed for a specific disease such as myomas, uterine infections, etc.
- -
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 |
|---|---|---|
| Prevelance of Uterine Vein and Uterine Vein System Variations (anatomical study)Also: Single arm anatomical study describing the prevalance and anatomical variations of superficial and deep veins in endometrial and cervical cancer patientsSingle arm anatomical study describing the prevalance and anatomical variations of superficial and deep veins in endometrial and cervical cancer patients | Other | prevalance and anatomical variations of superficial and deep veins |
Primary outcome
To describe the prevalence of uterine vein and uterine vein system variations
Time frame: 2 years
To describe the prevalence of uterine vein and uterine vein system variations
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: Yes. all information stated in this document is open to to third parties whitout any limitations
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.
Samet Topuz, MD study director
Istanbul Univrsity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevelance of Uterine Vein and Uterine Vein System Variations (anatomical study) in people with Uterine Vein Injury Left and Uterine Vein Injury Right, run by Istanbul 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 2 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: looking for participants now, as of the sponsor's last update on 25 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mustafa ALBAYRAK, MD (+90 532 687 10 51, mustafaalbayrak@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the prevalence of uterine vein and uterine vein system variations (time frame: 2 years). 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 25 Jul 2024.