Tactile Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding (TEA)
Tactile Versus Hysteroscopic Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding
Abnormal uterine bleeding (AUB) is any alteration in the pattern or volume of menstrual blood flow and heavy menstrual bleeding affects up to 30% of women at some time during their reproductive years. Abnormal menstruation can be due to conditions such as pregnancy complication uterine fibroids and adenomyosis, but in a large proportion of cases, the etiology is unclear, a condition generally referred to as dysfunctional uterine bleeding (DUB). Treatment options for DUB include symptomatic medical treatment or surgery, traditionally hysterectomy.
Hysteroscopically guided endometrial ablation methods have been shown to be effective and safe alternatives to hysterectomy for management of DUB. These methods require particular skills and experience and a long learning curve to be performed effectively and safely.
Through the past three decades DUB patients in Assiut university hospital were treated with either electrosurgical ablation or hysterectomy. When faced with hysteroscopic challenges during transcervical resection of the endometrium or rollerball coagulation, we used to shift to thermal balloon as backup method . However, expensive uterine balloon could not infrequently be afforded because of financial constrains and limited health resources . Therefore, another method was used as backup for hysteroscopic failures. It was first tried via insulating the conventional double-ended uterine curette then through a specially designed tactile electrosurgical ablation (TEA) probe.The technique of TEA is largely similar to the dilatation and curettage procedure both principally and practically. Hence, the basic requirements for its performance are the general awareness with electrosurgical principles and adequate experience in performing dilatation and curettage. TEA is done by specially designed tactile diathermy probe that carried the job of electrosurgical ablation without hysteroscopy or distension media first in an experimental session that clearly clarified the reproducibility of the depth of thermal damage and safety of the tactile electrosurgical ablator . Thereafter, TEA was successfully performed with satisfactory short and medium term outcomes for ten cases with DUB during an active, relentless bleeding attack. TEA is done under laparoscopic monitoring.
The aim of the present work is to present TEA as a simple, inexpensive, novel backup approach for treatment of DUB.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Assiut、埃及
- Woman's Health Hospital-Assiut University.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with dysfunctional uterine bleeding aged between 40 to 50 years
- Unsuccessful medical treatment.
- No intrauterine abnormalities.
- Endometrial biopsy negative for atypia and cancer.
- follicle stimulating hormone level not exceeds 30 mills-International unit
- Family complete
- Patients who are not candidate for hysterectomy because of medical or surgical risks.
Exclusion Criteria:
- Coexisting gynecological pathology (e.g. uterovaginal prolapsed, ovarian pathology, pelvic inflammatory disease, cervical atypia).
- Endometrial hyperplasia with atypia and cancer..
- History or evidence of malignancy.
- Hyperplasia in the endometrial biopsy.
- Uterine size more than 12 weeks in size.
- Women with caesarean or myomectomy scar
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 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:Group 1"Tactile electrosurgical ablation"
Endometrial ablation will be done by Tactile electrosurgical ablation probe.
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其他名称:
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有源比较器:Group 2 "Hysteroscopic endometrial ablation"
Hysteroscopic endometrial ablation will be done by trans-cervical resection of endometrium.
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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 |
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Satisfaction with the treatment at 12 month follow up
大体时间:12 moth
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Satisfaction with the treatment will be measured at 1 year post procedure on 3-point scale-very satisfied, satisfied, and not satisfied.
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12 moth
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Change in menstrual status.
大体时间:At 3, 6, 9, and12 months pot operatve.
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Menstrual status will be reported as
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At 3, 6, 9, and12 months pot operatve.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Acceptability of treatment
大体时间:4 weeks
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Acceptability of the procedure will be assessed in 3- point scale as cure or acceptable improvement in symptoms, treatment acceptable and would recommend treatment to others or not acceptable
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4 weeks
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Changes in health related quality of life
大体时间:At 3, 6, 9, and 12 months post operative.
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Health-related quality of life parameters will be completed using
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At 3, 6, 9, and 12 months post operative.
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Difference in operative time between the two groups in minutes.
大体时间:0-60 minutes
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Difference in operative time is calculated using a stop watch.The zero minute is the time of starting the procedure.
The stop watch is on at the zero minute then sopped at the end of the procedure.time of anesthesia is not included.
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0-60 minutes
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Reporting of any intro-operative complications.
大体时间:0-60 minutes.
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Intro-operative complications includes
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0-60 minutes.
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Reporting of any technical complications.
大体时间:0-60 minutes
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Technical complications for transcervical resection of the endometrium (TCRE) includes
Technical complications for tactile electrosurgical ablation (TEA) includes
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0-60 minutes
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Difference in post-operative pain score using visual analogue scale between the two groups.
大体时间:4 hours.
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Difference in post-operative pain score using visual analogue scale from 1-10.
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4 hours.
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Time needed for post operative recovery (days) of pain, vaginal bleeding, vaginal discharge, till full recovery and till return to work.
大体时间:28 days post operative
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28 days post operative
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Length of hospital stay in days
大体时间:up to 2 days
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Length of hospital stay in days is calculated from the day of operation till day of discharge.
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up to 2 days
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Difference in the cost of the two surgical procedure.
大体时间:up to one hour.
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Direct cost of the surgical procedure itself is calculated.The cost of the TCRE procedure will include the cost paid for the hysteroscopic unit and the cost of glycine used as distension media.The cost of the TEA procedure will include the cost of laparoscopy, the cost of TEA probe, and the cost of diagnostic hysteroscopy.
The cost of the investigations, anesthesia, pre and post operative treatments will be excluded from analysis as they are the same for both groups.
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up to one hour.
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- Tactile ablation
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Hysteroscopic endometrial ablation的临床试验
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CSA Medical, Inc.终止