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Surgicel® & Endometrial Ablation in the Management of Perimenpausal Heavy Menstrual Bleeding

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ClinicalTrials.gov Identifier: NCT03176992
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Moutaz Sherbini, Cairo University

Brief Summary:
Two hundred & forty patients aged from 40 to 50 years - complaining of heavy menstrual bleeding that is unresponsive to hormonal lines of treatment & requesting conservative surgical approach- 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.All patients were followed up over duration of 18 months following the procedure (at 3,6,12 & 18 months). Primary outcome included amenorrhea rates

Condition or disease Intervention/treatment Phase
Endometrial Hyperplasia Drug: SURGICEL® Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Surgicel® Versus Endometrial Ablation in the Management of Perimenpausal Heavy Menstrual Bleeding (HMB): Randomised Controlled Trial
Actual Study Start Date : June 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Surgicel group
80 patients underwent formal curettage followed by insertion of 4 pieces of Surgicel inside the uterine cavity
Drug: SURGICEL®
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



Primary Outcome Measures :
  1. amenorrhea rates [ Time Frame: 18 months ]
    absence of menstruation


Secondary Outcome Measures :
  1. 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

  2. dysmenorrhea rates [ Time Frame: 18 months ]
    occurrence of painful menstruation

  3. patient satisfaction [ Time Frame: 18 months ]
    simple questions about decreasing duration & amount of menstrual blood & better quality of life

  4. the need for re-intervention [ Time Frame: 18 months ]
    hysterectomy



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03176992


Contacts
Contact: MOUTAZ ELSHERBINI, MD (+20)01001588300 mizosherbini@yahoo.com
Contact: FADEL SHALTOUT, MD

Locations
Egypt
kasr elaini hospital (Cairo university) Recruiting
Cairo, Egypt, 115431
Contact: MOUTAZ ELSHERBINI, MD    (+2)01001588300    mizosherbini@yahoo.com   
Principal Investigator: MOUTAZ ELSHERBINI, md         
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: MOUTAZ ELSHERBINI, MD Assistant professor of obstetrics and gynecology

Responsible Party: Moutaz Sherbini, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03176992     History of Changes
Other Study ID Numbers: 250597
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017

Keywords provided by Moutaz Sherbini, Cairo University:
ablation
surgicel

Additional relevant MeSH terms:
Hyperplasia
Menorrhagia
Endometrial Hyperplasia
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances