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

June 5, 2017 updated by: Moutaz Sherbini, Cairo University

Surgicel® Versus Endometrial Ablation in the Management of Perimenpausal Heavy Menstrual Bleeding (HMB): Randomised Controlled Trial

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

Study Overview

Status

Unknown

Intervention / Treatment

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

Enrollment (Anticipated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: FADEL SHALTOUT, MD

Study Locations

      • Cairo, Egypt, 115431
        • Recruiting
        • kasr elaini hospital (Cairo university)
        • Contact:
        • Principal Investigator:
          • Moutaz Elsherbini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: moutaz elsherbini, MD, Assistant Professor of obstetrics and gynecology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (Actual)

June 6, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 5, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

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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