Tactile Electrosurgical Ablation in Cases of Dysfunctional Uterine Bleeding

NCT ID: NCT02248194

Last Updated: 2016-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Dysfunction Uterine Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1"Tactile electrosurgical ablation"

Endometrial ablation will be done by Tactile electrosurgical ablation probe.

Group Type: EXPERIMENTAL

Hysteroscopic endometrial ablation

Intervention Type: DEVICE

Group 2 "Hysteroscopic endometrial ablation"

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

Group Type: ACTIVE_COMPARATOR

Tactile electrosurgical ablation probe

Intervention Type: DEVICE

Interventions

Tactile electrosurgical ablation probe

Intervention Type: DEVICE

Hysteroscopic endometrial ablation

Intervention Type: DEVICE

Other Intervention Names

Transcervical resection of the endometrium

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: collaborator

Mostafa Hussein

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Hussein

Dr

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Woman's Health Hospital-Assiut University.

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Tactile ablation

Identifier Type: -

Identifier Source: org_study_id