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Tactile Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding (TEA)

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ClinicalTrials.gov Identifier: NCT02248194
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
Assiut University
Information provided by (Responsible Party):
Mostafa Hussein, Assiut University

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.


Condition or disease Intervention/treatment Phase
Dysfunction Uterine Bleeding Device: Tactile electrosurgical ablation probe Device: Hysteroscopic endometrial ablation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Tactile Versus Hysteroscopic Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding
Study Start Date : April 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Group 1"Tactile electrosurgical ablation"
Endometrial ablation will be done by Tactile electrosurgical ablation probe.
Device: Hysteroscopic endometrial ablation
Other Name: Transcervical resection of the endometrium

Active Comparator: Group 2 "Hysteroscopic endometrial ablation"
Hysteroscopic endometrial ablation will be done by trans-cervical resection of endometrium.
Device: Tactile electrosurgical ablation probe



Primary Outcome Measures :
  1. Satisfaction with the treatment at 12 month follow up [ Time Frame: 12 moth ]
    Satisfaction with the treatment will be measured at 1 year post procedure on 3-point scale-very satisfied, satisfied, and not satisfied.

  2. Change in menstrual status. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Acceptability of treatment [ Time Frame: 4 weeks ]
    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

  2. Changes in health related quality of life [ Time Frame: At 3, 6, 9, and 12 months post operative. ]

    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.

  3. Difference in operative time between the two groups in minutes. [ Time Frame: 0-60 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.

  4. Reporting of any intro-operative complications. [ Time Frame: 0-60 minutes. ]

    Intro-operative complications includes

    • Cervical laceration.
    • Perforation of the uterus.
    • Hemorrhage
    • Fluid overload.

  5. Reporting of any technical complications. [ Time Frame: 0-60 minutes ]

    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.

  6. Difference in post-operative pain score using visual analogue scale between the two groups. [ Time Frame: 4 hours. ]
    Difference in post-operative pain score using visual analogue scale from 1-10.

  7. Time needed for post operative recovery (days) of pain, vaginal bleeding, vaginal discharge, till full recovery and till return to work. [ Time Frame: 28 days post operative ]
  8. Length of hospital stay in days [ Time Frame: up to 2 days ]
    Length of hospital stay in days is calculated from the day of operation till day of discharge.

  9. Difference in the cost of the two surgical procedure. [ Time Frame: up to one hour. ]
    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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Ages Eligible for Study:   40 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248194


Locations
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Egypt
Woman's Health Hospital-Assiut University.
Assiut, Egypt
Sponsors and Collaborators
Mostafa Hussein
Assiut University
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Responsible Party: Mostafa Hussein, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02248194    
Other Study ID Numbers: Tactile ablation
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015
Keywords provided by Mostafa Hussein, Assiut University:
Dysfunction uterine bleeding
Hysteroscopic endometrial ablation
Tactile endometrial ablation
Hysteroscopic difficulties
Quality of life
Satisfaction
Additional relevant MeSH terms:
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Uterine Hemorrhage
Metrorrhagia
Hemorrhage
Pathologic Processes
Uterine Diseases