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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 : Unknown
Verified June 2017 by Moutaz Sherbini, Cairo University.
Recruitment status was:  Recruiting
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Moutaz Sherbini, Cairo University

Tracking Information
First Submitted Date  ICMJE June 2, 2017
First Posted Date  ICMJE June 6, 2017
Last Update Posted Date June 6, 2017
Actual Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
amenorrhea rates [ Time Frame: 18 months ]
absence of menstruation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
  • 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
  • dysmenorrhea rates [ Time Frame: 18 months ]
    occurrence of painful menstruation
  • patient satisfaction [ Time Frame: 18 months ]
    simple questions about decreasing duration & amount of menstrual blood & better quality of life
  • the need for re-intervention [ Time Frame: 18 months ]
    hysterectomy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgicel® & Endometrial Ablation in the Management of Perimenpausal Heavy Menstrual Bleeding
Official Title  ICMJE Surgicel® Versus Endometrial Ablation in the Management of Perimenpausal Heavy Menstrual Bleeding (HMB): Randomised Controlled Trial
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE Endometrial Hyperplasia
Intervention  ICMJE Drug: SURGICEL®
insertion of 4 pieces of Surgicel inside the uterine cavity after formal curettage
Study Arms  ICMJE
  • Active Comparator: Surgicel group
    80 patients underwent formal curettage followed by insertion of 4 pieces of Surgicel inside the uterine cavity
    Intervention: Drug: SURGICEL®
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 5, 2017)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03176992
Other Study ID Numbers  ICMJE 250597
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Moutaz Sherbini, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: MOUTAZ ELSHERBINI, MD Assistant professor of obstetrics and gynecology
PRS Account Cairo University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP