Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical Conization | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Preoperatively and at 1 month postoperatively |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gorkem Ulger, M.D. | NiÄŸde Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adana City Training and Research Hospital | Adana | 01230 | Turkey (Türkiye) |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019092 | Conization |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
Not provided
Not provided
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.
Not provided
Not provided
The independent specialist performing all preoperative and postoperative transvaginal Doppler evaluations was completely blinded to the intraoperative details and surgical modification groups.
|
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |