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

NCT ID: NCT03176992

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-02-28

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).

Conditions

Endometrial Hyperplasia

Study Design

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

Study Groups

Surgicel group

80 patients underwent formal curettage followed by insertion of 4 pieces of Surgicel inside the uterine cavity

Group Type: ACTIVE_COMPARATOR

SURGICEL®

Intervention Type: DRUG

insertion of 4 pieces of Surgicel inside the uterine cavity after formal curettage

Thermal balloon ablation group

80 patients underwent thermal balloon ablation using bipolar radiofrequency electrical energy (Novasure)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Endometrial resection group

80 patients underwent transcervical Hysteroscopic endometrial resection

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SURGICEL®

insertion of 4 pieces of Surgicel inside the uterine cavity after formal curettage

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Moutaz Sherbini

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MOUTAZ ELSHERBINI, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of obstetrics and gynecology

Locations

kasr elaini hospital (Cairo university)

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

MOUTAZ ELSHERBINI, MD

Role: CONTACT

mizosherbini@yahoo.com

(+20)01001588300

FADEL SHALTOUT, MD

Role: CONTACT

Facility Contacts

MOUTAZ ELSHERBINI, MD

Role: primary

mizosherbini@yahoo.com

(+2)01001588300

Other Identifiers

250597

Identifier Type: -

Identifier Source: org_study_id