search
Back to results

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

Primary Purpose

Dysfunction Uterine Bleeding

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Tactile electrosurgical ablation probe
Hysteroscopic endometrial ablation
Sponsored by
Mostafa Hussein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysfunction Uterine Bleeding focused on measuring Dysfunction uterine bleeding, Hysteroscopic endometrial ablation, Tactile endometrial ablation, Hysteroscopic difficulties, Quality of life, Satisfaction

Eligibility Criteria

40 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Woman's Health Hospital-Assiut University.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1"Tactile electrosurgical ablation"

Group 2 "Hysteroscopic endometrial ablation"

Arm Description

Endometrial ablation will be done by Tactile electrosurgical ablation probe.

Hysteroscopic endometrial ablation will be done by trans-cervical resection of endometrium.

Outcomes

Primary Outcome Measures

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.
Change in menstrual status.
Menstrual status will be reported as Normal menstrual flow. Light menstrual bleeding. Heavy menstrual bleeding. The need for hysterectomy.

Secondary Outcome Measures

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
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.
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.
Reporting of any intro-operative complications.
Intro-operative complications includes Cervical laceration. Perforation of the uterus. Hemorrhage Fluid overload.
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.
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.
Time needed for post operative recovery (days) of pain, vaginal bleeding, vaginal discharge, till full recovery and till return to work.
Length of hospital stay in days
Length of hospital stay in days is calculated from the day of operation till day of discharge.
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.

Full Information

First Posted
January 22, 2014
Last Updated
December 30, 2015
Sponsor
Mostafa Hussein
Collaborators
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT02248194
Brief Title
Tactile Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding
Acronym
TEA
Official Title
Tactile Versus Hysteroscopic Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mostafa Hussein
Collaborators
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysfunction Uterine Bleeding
Keywords
Dysfunction uterine bleeding, Hysteroscopic endometrial ablation, Tactile endometrial ablation, Hysteroscopic difficulties, Quality of life, Satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1"Tactile electrosurgical ablation"
Arm Type
Experimental
Arm Description
Endometrial ablation will be done by Tactile electrosurgical ablation probe.
Arm Title
Group 2 "Hysteroscopic endometrial ablation"
Arm Type
Active Comparator
Arm Description
Hysteroscopic endometrial ablation will be done by trans-cervical resection of endometrium.
Intervention Type
Device
Intervention Name(s)
Tactile electrosurgical ablation probe
Intervention Type
Device
Intervention Name(s)
Hysteroscopic endometrial ablation
Other Intervention Name(s)
Transcervical resection of the endometrium
Primary Outcome Measure Information:
Title
Satisfaction with the treatment at 12 month follow up
Description
Satisfaction with the treatment will be measured at 1 year post procedure on 3-point scale-very satisfied, satisfied, and not satisfied.
Time Frame
12 moth
Title
Change in menstrual status.
Description
Menstrual status will be reported as Normal menstrual flow. Light menstrual bleeding. Heavy menstrual bleeding. The need for hysterectomy.
Time Frame
At 3, 6, 9, and12 months pot operatve.
Secondary Outcome Measure Information:
Title
Acceptability of treatment
Description
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
Time Frame
4 weeks
Title
Changes in health related quality of life
Description
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.
Time Frame
At 3, 6, 9, and 12 months post operative.
Title
Difference in operative time between the two groups in minutes.
Description
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.
Time Frame
0-60 minutes
Title
Reporting of any intro-operative complications.
Description
Intro-operative complications includes Cervical laceration. Perforation of the uterus. Hemorrhage Fluid overload.
Time Frame
0-60 minutes.
Title
Reporting of any technical complications.
Description
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.
Time Frame
0-60 minutes
Title
Difference in post-operative pain score using visual analogue scale between the two groups.
Description
Difference in post-operative pain score using visual analogue scale from 1-10.
Time Frame
4 hours.
Title
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
Title
Length of hospital stay in days
Description
Length of hospital stay in days is calculated from the day of operation till day of discharge.
Time Frame
up to 2 days
Title
Difference in the cost of the two surgical procedure.
Description
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.
Time Frame
up to one hour.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Woman's Health Hospital-Assiut University.
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Tactile Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding

We'll reach out to this number within 24 hrs