- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07653191
Changes in Uterine Artery Resistance Index Following Cervical Conization
June 12, 2026 updated by: Gorkem Ulger, Adana City Training and Research Hospital
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Adana, Turkey (Türkiye), 01230
- Adana City Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Suture Group
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.
|
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.
|
|
Active Comparator: No Suture Group
Participants assigned to undergo the cervical conization procedure executed without the placement of any 3 and 9 o'clock cervical lateral sutures.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Preoperatively and at 1 month postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gorkem Ulger, M.D., Niğde Training and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2018
Primary Completion (Actual)
October 30, 2018
Study Completion (Actual)
October 30, 2018
Study Registration Dates
First Submitted
June 12, 2026
First Submitted That Met QC Criteria
June 12, 2026
First Posted (Actual)
June 17, 2026
Study Record Updates
Last Update Posted (Actual)
June 17, 2026
Last Update Submitted That Met QC Criteria
June 12, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Precancerous Conditions
- Uterine Cervical Diseases
- Pregnancy Complications
- Uterine Cervical Dysplasia
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Cytological Techniques
- Biopsy
- Cytodiagnosis
- Diagnostic Techniques, Surgical
- Conization
Other Study ID Numbers
- 189
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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