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临床试验/NCT02248194
NCT02248194已完成2 期

Tactile Versus Hysteroscopic Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding

Mostafa Hussein1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2010年4月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
108
试验地点
1
主要终点
Change in menstrual status.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Group 1"Tactile electrosurgical ablation"

Experimental

Endometrial ablation will be done by Tactile electrosurgical ablation probe.

干预措施: Hysteroscopic endometrial ablation (Device)

Group 2 "Hysteroscopic endometrial ablation"

Active Comparator

Hysteroscopic endometrial ablation will be done by trans-cervical resection of endometrium.

干预措施: Tactile electrosurgical ablation probe (Device)

结局指标

主要结局

Change in menstrual status.

时间窗: At 3, 6, 9, and12 months pot operatve.

Menstrual status will be reported as * Normal menstrual flow. * Light menstrual bleeding. * Heavy menstrual bleeding. * The need for hysterectomy.

Satisfaction with the treatment at 12 month follow up

时间窗: 12 moth

Satisfaction with the treatment will be measured at 1 year post procedure on 3-point scale-very satisfied, satisfied, and not satisfied.

次要结局

  • Difference in operative time between the two groups in minutes.(0-60 minutes)
  • Changes in health related quality of life(At 3, 6, 9, and 12 months post operative.)
  • Length of hospital stay in days(up to 2 days)
  • Reporting of any intro-operative complications.(0-60 minutes.)
  • Difference in post-operative pain score using visual analogue scale between the two groups.(4 hours.)
  • Acceptability of treatment(4 weeks)
  • Reporting of any technical complications.(0-60 minutes)
  • Time needed for post operative recovery (days) of pain, vaginal bleeding, vaginal discharge, till full recovery and till return to work.(28 days post operative)
  • Difference in the cost of the two surgical procedure.(up to one hour.)

研究者

发起方
Mostafa Hussein
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mostafa Hussein

Dr

Assiut University

研究点 (1)

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