Dysfunction Uterine Bleeding Clinical Trial
— TEAOfficial title:
Tactile Versus Hysteroscopic Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding
| Verified date | December 2015 |
| Source | Assiut University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Egypt: Assiut Medical School Ethical Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 108 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 40 Years to 50 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Woman's Health Hospital-Assiut University. | Assiut |
| Lead Sponsor | Collaborator |
|---|---|
| Mostafa Hussein | Assiut University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Satisfaction with the treatment at 12 month follow up | Satisfaction with the treatment will be measured at 1 year post procedure on 3-point scale—very satisfied, satisfied, and not satisfied. | 12 moth | No |
| Primary | Change in menstrual status. | Menstrual status will be reported as Normal menstrual flow. Light menstrual bleeding. Heavy menstrual bleeding. The need for hysterectomy. |
At 3, 6, 9, and12 months pot operatve. | No |
| Secondary | Acceptability of treatment | 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 | 4 weeks | No |
| Secondary | Changes in health related quality of life | Health-related quality of life parameters will be completed using Short form-12 (SF12). Life style questionnaires including Work affection will be measured by the number of days absence from the work due to menses as following, non ,non but work suffer, 1 day and >2 days. sexual life affection will be measured in two point as no or yes. |
At 3, 6, 9, and 12 months post operative. | No |
| Secondary | Difference in operative time between the two groups in minutes. | 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. | 0-60 minutes | No |
| Secondary | Reporting of any intro-operative complications. | Intro-operative complications includes Cervical laceration. Perforation of the uterus. Hemorrhage Fluid overload. |
0-60 minutes. | Yes |
| Secondary | Reporting of any technical complications. | Technical complications for transcervical resection of the endometrium (TCRE) includes Poor uterine distention. Slow clearance of the debris. Inefficient cutting. Poor visualization. problem of diathermy. Problems with the camera. problems with light source. Technical complications for tactile electrosurgical ablation (TEA) includes Insulation problem. Connection problem. Inefficient diathermy power. |
0-60 minutes | Yes |
| Secondary | Difference in post-operative pain score using visual analogue scale between the two groups. | Difference in post-operative pain score using visual analogue scale from 1-10. | 4 hours. | No |
| Secondary | 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 | No | |
| Secondary | Length of hospital stay in days | Length of hospital stay in days is calculated from the day of operation till day of discharge. | up to 2 days | No |
| Secondary | Difference in the cost of the two surgical procedure. | 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. | up to one hour. | No |