Clinical trial NCT02248194: Tactile Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding
Official title: Tactile Versus Hysteroscopic Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dysfunction Uterine Bleeding
Keywords: Dysfunction uterine bleeding
Hysteroscopic endometrial ablation
Tactile endometrial ablation
Hysteroscopic difficulties
Quality of life
Satisfaction
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2014-09-25
Enrollment: 108
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction with the treatment at 12 month follow up
timeFrame: 12 moth
measure: Change in menstrual status.
timeFrame: At 3, 6, 9, and12 months pot operatve.
Secondary outcomes:
measure: Acceptability of treatment
timeFrame: 4 weeks
measure: Changes in health related quality of life
timeFrame: At 3, 6, 9, and 12 months post operative.
measure: Difference in operative time between the two groups in minutes.
timeFrame: 0-60 minutes
measure: Reporting of any intro-operative complications.
timeFrame: 0-60 minutes.
measure: Reporting of any technical complications.
timeFrame: 0-60 minutes
measure: Difference in post-operative pain score using visual analogue scale between the two groups.
timeFrame: 4 hours.
measure: Time needed for post operative recovery (days) of pain, vaginal bleeding, vaginal discharge, till full recovery and till return to work.
timeFrame: 28 days post operative
measure: Length of hospital stay in days
timeFrame: up to 2 days
measure: Difference in the cost of the two surgical procedure.
timeFrame: up to one hour.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Woman's Health Hospital-Assiut University.
Study officials:
References: