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

30 december 2015 bijgewerkt door: Mostafa Hussein

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.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

108

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Assiut, Egypte
        • Woman's Health Hospital-Assiut University.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group 1"Tactile electrosurgical ablation"
Endometrial ablation will be done by Tactile electrosurgical ablation probe.
Andere namen:
  • Transcervical resection of the endometrium
Actieve vergelijker: Group 2 "Hysteroscopic endometrial ablation"
Hysteroscopic endometrial ablation will be done by trans-cervical resection of endometrium.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Satisfaction with the treatment at 12 month follow up
Tijdsspanne: 12 moth
Satisfaction with the treatment will be measured at 1 year post procedure on 3-point scale-very satisfied, satisfied, and not satisfied.
12 moth
Change in menstrual status.
Tijdsspanne: 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.
At 3, 6, 9, and12 months pot operatve.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Acceptability of treatment
Tijdsspanne: 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
4 weeks
Changes in health related quality of life
Tijdsspanne: 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.
At 3, 6, 9, and 12 months post operative.
Difference in operative time between the two groups in minutes.
Tijdsspanne: 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.
0-60 minutes
Reporting of any intro-operative complications.
Tijdsspanne: 0-60 minutes.

Intro-operative complications includes

  • Cervical laceration.
  • Perforation of the uterus.
  • Hemorrhage
  • Fluid overload.
0-60 minutes.
Reporting of any technical complications.
Tijdsspanne: 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.
0-60 minutes
Difference in post-operative pain score using visual analogue scale between the two groups.
Tijdsspanne: 4 hours.
Difference in post-operative pain score using visual analogue scale from 1-10.
4 hours.
Time needed for post operative recovery (days) of pain, vaginal bleeding, vaginal discharge, till full recovery and till return to work.
Tijdsspanne: 28 days post operative
28 days post operative
Length of hospital stay in days
Tijdsspanne: up to 2 days
Length of hospital stay in days is calculated from the day of operation till day of discharge.
up to 2 days
Difference in the cost of the two surgical procedure.
Tijdsspanne: 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.
up to one hour.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Medewerkers

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2010

Primaire voltooiing (Werkelijk)

1 december 2014

Studie voltooiing (Werkelijk)

1 december 2014

Studieregistratiedata

Eerst ingediend

22 januari 2014

Eerst ingediend dat voldeed aan de QC-criteria

22 september 2014

Eerst geplaatst (Schatting)

25 september 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

1 januari 2016

Laatste update ingediend die voldeed aan QC-criteria

30 december 2015

Laatst geverifieerd

1 december 2015

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Klinische onderzoeken op Hysteroscopic endometrial ablation

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