Dysfunction Uterine Bleeding Clinical Trial
Official title:
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment