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

Endometrial Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03176992
• Other study ID #: 250597
• Status: Recruiting
• Phase: Phase 2
• First received: June 2, 2017
• Last updated: June 5, 2017
• Start date: June 2015
• Est. completion date: February 2018

Study information

• Verified date: June 2017
• Source: Cairo University
• Contact: MOUTAZ ELSHERBINI, MD
• Phone: (+20)01001588300
• Email: mizosherbini[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Hyperplasia
• Menorrhagia

Intervention

Drug:
• SURGICEL®
insertion of 4 pieces of Surgicel inside the uterine cavity after formal curettage

Locations

Country	Name	City	State
Egypt	kasr elaini hospital (Cairo university)	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amenorrhea rates	absence of menstruation	18 months
Secondary	PBAC score (pictorial blood loss assessment chart score)	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
Secondary	dysmenorrhea rates	occurrence of painful menstruation	18 months
Secondary	patient satisfaction	simple questions about decreasing duration & amount of menstrual blood & better quality of life	18 months
Secondary	the need for re-intervention	hysterectomy	18 months