Changes in Uterine Artery Resistance Index Following Cervical Conization
2026年6月12日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Adana、土耳其（türkiye）、01230
- Adana City Training and Research Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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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.
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有源比较器：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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Uterine Artery Resistance Index (RI)
大体时间：Preoperatively and at 1 month postoperatively
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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
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Gorkem Ulger, M.D.、Niğde Training and Research Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年6月20日
初级完成 (实际的)
2018年10月30日
研究完成 (实际的)
2018年10月30日
研究注册日期
首次提交
2026年6月12日
首先提交符合 QC 标准的
2026年6月12日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年6月17日
上次提交的符合 QC 标准的更新
2026年6月12日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 189
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.