Cervical Intraepithelial NeoplasiaNCT07653191
Changes in Uterine Artery Resistance Index Following Cervical Conization
A study testing Cervical Conization in people with Cervical Intraepithelial Neoplasia and Uterine Artery Hemodynamics, run by Adana City Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The objective of this prospective study is to evaluate the hemodynamic impact of cervical conization on uterine artery blood flow by focusing on the Resistance Index (RI) as a direct indicator of distal vascular resistance. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Uterine Artery Hemodynamics
- What is being tested?
- Cervical Conization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2018to 30 Oct 2018
- 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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Regularly menstruating female patients aged between 30 and 50 years.
- Definitive clinical indication for cervical conization based on abnormal cervical cytology, positive HPV screening, or colposcopy-guided biopsy findings.
Who cannot join
- Concomitant pelvic pathologies that could independently alter uterine artery blood flow or Doppler indices, such as uterine fibroids, ovarian cysts, endometriosis, pelvic inflammatory disease (PID), or hydrosalpinx.
- Acute postoperative bleeding complications.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana City Training and Research Hospital
Adana, 01230
About this study
Official title: Evaluation of the Hemodynamic Resistance: Changes in Uterine Artery Resistance Index Following Cervical Conization
The objective of this prospective study is to evaluate the hemodynamic impact of cervical conization on uterine artery blood flow by focusing on the Resistance Index (RI) as a direct indicator of distal vascular resistance. The central hypothesis is predicated on the physiological principle that the surgical excision and subsequent sealing of terminal cervical branches during conization increases the distal vascular impedance (afterload) encountered by the main uterine artery. Uterine artery Doppler RI measurements are performed preoperatively and at one month postoperatively to assess these alterations.
Read the detailed description
Eligible patients undergoing cervical conization are evaluated using transvaginal color Doppler sonography to examine alterations in bilateral uterine artery blood flow. Sonographic examinations are standardized and conducted during the follicular phase of the menstrual cycle, both preoperatively and at the one-month postoperative follow-up visit. Participant allocation to surgical modification groups is determined through a randomization process, where patients receive either hemostatic lateral sutures placed at the 3 and 9 o'clock positions of the cervix or undergo the procedure without any lateral sutures. Fresh pathology specimens are systematically weighed and measured for volume. Postoperative changes in the right and left uterine artery Resistance Index (Delta RI) are analyzed to determine the independent effects of surgical techniques, specimen physical dimensions, and histopathological lesion severity on uterine hemodynamics.
- Being tested
- Cervical Conization
- Keywords
- Cervical conization, Uterine artery Doppler, Resistance index, Vascular resistance, Pregnancy complications
- Medical subject headings
- Uterine Cervical Dysplasia, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical ConizationProcedure or surgery
Surgical excision of a symmetric cervical cone specimen surrounding the endocervical canal. The procedure is executed under general anesthesia using electrocautery via the Covidien Forcetriad energy platform with restricted power levels (Coagulation: 40 W, Cutting: 40 W) to minimize secondary thermal tissue damage.
| Study group | Role | What they receive |
|---|---|---|
| Suture Group | Experimental | Participants assigned to undergo cervical conization with the placement of hemostatic 1/0 absorbable polyglycolic acid sutures at the 3 and 9 o'clock positions of the cervix for traction and immediate hemostasis. Receives: Procedure: Cervical Conization |
| No Suture Group | Active comparator | Participants assigned to undergo the cervical conization procedure executed without the placement of any 3 and 9 o'clock cervical lateral sutures. Receives: Procedure: Cervical Conization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Uterine Artery Resistance Index (RI)
Evaluation of bilateral uterine artery Doppler Resistance Index (RI) waveforms to measure modifications in downstream distal vascular resistance following microvascular occlusion.
Measured: Preoperatively and at 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start20 Jun 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized parallel group design evaluating patients who undergo cervical conization either with or without the placement of hemostatic sutures at the 3 and 9 o'clock positions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adana City Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gorkem Ulger, Adana City Training and Research Hospital
- Investigators
- Gorkem Ulger, M.D., Principal investigator, Niğde Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653191
- Sponsor's protocol ID
- 189
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during the study will not be made available to other researchers to protect participant confidentiality and comply with institutional privacy regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hemodynamic Resistance: Changes in Uterine Artery Resistance Index Following Cervical Conization
- ClinicalTrials.gov ID
- NCT07653191
- Acronym / sponsor ID
- 189
- Keywords
- Cervical conization, Uterine artery Doppler, Resistance index, Vascular resistance, Pregnancy complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Adana City Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 17 Jun 2026 (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 objective of this prospective study is to evaluate the hemodynamic impact of cervical conization on uterine artery blood flow by focusing on the Resistance Index (RI) as a direct indicator of distal vascular resistance. The central hypothesis is predicated on the physiological principle that the surgical excision and subsequent sealing of terminal cervical branches during conization increases the distal vascular impedance (afterload) encountered by the main uterine artery. Uterine artery Doppler RI measurements are performed preoperatively and at one month postoperatively to assess these alterations.
Detailed description
Eligible patients undergoing cervical conization are evaluated using transvaginal color Doppler sonography to examine alterations in bilateral uterine artery blood flow. Sonographic examinations are standardized and conducted during the follicular phase of the menstrual cycle, both preoperatively and at the one-month postoperative follow-up visit. Participant allocation to surgical modification groups is determined through a randomization process, where patients receive either hemostatic lateral sutures placed at the 3 and 9 o'clock positions of the cervix or undergo the procedure without any lateral sutures. Fresh pathology specimens are systematically weighed and measured for volume. Postoperative changes in the right and left uterine artery Resistance Index (Delta RI) are analyzed to determine the independent effects of surgical techniques, specimen physical dimensions, and histopathological lesion severity on uterine hemodynamics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized parallel group design evaluating patients who undergo cervical conization either with or without the placement of hemostatic sutures at the 3 and 9 o'clock positions.
| Arm | Type | Receives |
|---|---|---|
| Suture Group | Experimental | Procedure: Cervical ConizationParticipants assigned to undergo cervical conization with the placement of hemostatic 1/0 absorbable polyglycolic acid sutures at the 3 and 9 o'clock positions of the cervix for traction and immediate hemostasis. |
| No Suture Group | Active comparator | Procedure: Cervical ConizationParticipants assigned to undergo the cervical conization procedure executed without the placement of any 3 and 9 o'clock cervical lateral sutures. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Regularly menstruating female patients aged between 30 and 50 years.
- Definitive clinical indication for cervical conization based on abnormal cervical cytology, positive HPV screening, or colposcopy-guided biopsy findings.
Key exclusion criteria (2 listed)
- Concomitant pelvic pathologies that could independently alter uterine artery blood flow or Doppler indices, such as uterine fibroids, ovarian cysts, endometriosis, pelvic inflammatory disease (PID), or hydrosalpinx.
- Acute postoperative bleeding complications.
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 |
|---|---|---|
| Cervical ConizationSurgical excision of a symmetric cervical cone specimen surrounding the endocervical canal. The procedure is executed under general anesthesia using electrocautery via the Covidien Forcetriad energy platform with restricted power levels (Coagulation: 40 W, Cutting: 40 W) to minimize secondary thermal tissue damage. | Procedure or surgery | No Suture Group, Suture Group |
Primary outcome
Change in Uterine Artery Resistance Index (RI)
Time frame: Preoperatively and at 1 month postoperatively
Evaluation of bilateral uterine artery Doppler Resistance Index (RI) waveforms to measure modifications in downstream distal vascular resistance following microvascular occlusion.
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 17 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during the study will not be made available to other researchers to protect participant confidentiality and comply with institutional privacy regulations.
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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.
Gorkem Ulger, M.D. principal investigator
Niğde Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Conization in people with Cervical Intraepithelial Neoplasia and Uterine Artery Hemodynamics, run by Adana City Training and Research 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 2 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: finished, as of the sponsor's last update on 17 Jun 2026. 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?
Change in Uterine Artery Resistance Index (RI) (time frame: Preoperatively and at 1 month postoperatively). 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 17 Jun 2026.