- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03176992
Surgicel® & Endometrial Ablation in the Management of Perimenpausal Heavy Menstrual Bleeding
Surgicel® Versus Endometrial Ablation in the Management of Perimenpausal Heavy Menstrual Bleeding (HMB): Randomised Controlled Trial
Study Overview
Detailed Description
Two hundred & forty patients aged from 40 to 50 years complaining of heavy menstrual bleeding (i.e. pictorial blood loss assessment chart score >150) that is unresponsive to hormonal lines of treatment & requesting conservative surgical approach. Participants were randomized into 3 groups; group A (Surgicel group) in which 80 patients underwent formal curettage followed by insertion of 4 pieces of Surgicel inside the uterine cavity, group B (Thermal balloon ablation group) in which 80 patients underwent thermal balloon ablation using bipolar radiofrequency electrical energy (Novasure), group C (Endometrial resection group) in which 80 patients underwent transcervical Hysteroscopic endometrial resection. Randomization was done using computer generated random numbers.
Inclusion criteria included uterine length <12 cm, FSH level > 40 IU/L, normal Pap smear & benign endometrial pathology. Exclusion criteria included active form of PID, uterine scars, uterine malformation, uterine organic lesions (e.g., fibroids, polyps & Adenomyosis) & previous history of endometrial ablation. In addition, patients seeking fertility preservation, suffering coagulopathies or receiving anticoagulant treatments were excluded.
For all patients, full history was taken followed by complete physical examination (with emphasis on speculum examination to exclude cervical or vaginal wall lesions) & laboratory investigations (FSH, coagulation profile & routine preoperative investigations). History of Pap smear schedule was obtained and a Pap smear was scheduled if it was due. Transvaginal ultrasound (TVUS) was done using a 7.5 MHz vaginal probe of the General Electric Voluson E8 ultrasound unit (GE Healthcare Austria GmbH, Seoul, Korea) to assess uterine size and to exclude organic lesions of the uterus or ovaries. All participants were subjected to an endometrial biopsy (either before the procedure or intraoperatively followed by a frozen section). Patients, who were found to have atypical endometrial hyperplasia or endometrial malignancy, were excluded from the study.
In the Surgicel group (group A), each SURGICEL® (oxidized regenerated cellulose - Ethicon US, LLC.) knitted fabric (5 x 10 cm) was divided into four equal pieces. A formal cervical dilatation & curettage was done followed by packing the uterine cavity with the four SURGICEL® strips to ensure that the SURGICEL® is in contact with the basal endometrium all over the cavity.
In group B, Thermal balloon ablation was done using bipolar radiofrequency electrical energy (Novasure). The cervix was grasped with a tenaculum then dilated to 6 mm. The disposable device was inserted in the uterine cavity until the distal end of the sheath touches the fundus then withdrawn backwards approximately 0.5 cm. The cervical collar was slided forward until it forms a seal against the external cervical os. The ablation cycle starts automatically, upon successful completion of the cavity integrity assessment (CIA), & ends automatically as well. In group C, Transcervical hysteroscopic endometrial resection was done. Bipolar resectoscope is used & endometrium is resected in successive passes under direct hysteroscopic vision. Each pass of the U-shaped loop electrode removes a layer of tissue of approximately 3-5 mm.
All patients were followed up over duration of 18 months following the procedure (at 3,6,12 & 18 months). Primary outcome included amenorrhea rates & secondary outcomes included complication (intra- or post-operative), PBAC score (pictorial blood loss assessment chart score), dysmenorrhea rates, patient satisfaction & the need for re-intervention (hysterectomy).
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: MOUTAZ ELSHERBINI, MD
- Phone Number: (+20)01001588300
- Email: mizosherbini@yahoo.com
Study Contact Backup
- Name: FADEL SHALTOUT, MD
Study Locations
-
-
-
Cairo, Egypt, 115431
- Recruiting
- kasr elaini hospital (Cairo university)
-
Contact:
- MOUTAZ ELSHERBINI, MD
- Phone Number: (+2)01001588300
- Email: mizosherbini@yahoo.com
-
Principal Investigator:
- Moutaz Elsherbini, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Heavy menstrual bleeding (i.e. pictorial blood loss assessment chart score >150) that unresponsive to hormonal lines of treatment & requesting conservative surgical approach.
- Uterine length <12 cm.
- FSH level > 40 IU/L
- Normal Pap smear
- Benign endometrial pathology
Exclusion Criteria:
- Active form of PID
- Uterine scars & uterine malformation.
- Uterine organic lesions (e.g., fibroids, polyps & Adenomyosis)
- Previous history of endometrial ablation.
- Patients seeking fertility preservation.
- Patients suffering coagulopathies or receiving anticoagulant treatments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Surgicel group
80 patients underwent formal curettage followed by insertion of 4 pieces of Surgicel inside the uterine cavity
|
insertion of 4 pieces of Surgicel inside the uterine cavity after formal curettage
|
No Intervention: Thermal balloon ablation group
80 patients underwent thermal balloon ablation using bipolar radiofrequency electrical energy (Novasure)
|
|
No Intervention: Endometrial resection group
80 patients underwent transcervical Hysteroscopic endometrial resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
amenorrhea rates
Time Frame: 18 months
|
absence of menstruation
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PBAC score (pictorial blood loss assessment chart score)
Time Frame: 18 months
|
chart consists of a series of diagrams representing lightly, moderately and heavily soiled towels and tampons.The participants complete the chart each menstrual period after clear instructions and explanation of how it should be used
|
18 months
|
dysmenorrhea rates
Time Frame: 18 months
|
occurrence of painful menstruation
|
18 months
|
patient satisfaction
Time Frame: 18 months
|
simple questions about decreasing duration & amount of menstrual blood & better quality of life
|
18 months
|
the need for re-intervention
Time Frame: 18 months
|
hysterectomy
|
18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: moutaz elsherbini, MD, Assistant Professor of obstetrics and gynecology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 250597
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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