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
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Hyperplasia||Drug: SURGICEL®||Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|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|
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
- amenorrhea rates [ Time Frame: 18 months ]absence of menstruation
- 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
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
|Contact: MOUTAZ ELSHERBINI, MD||(+20)firstname.lastname@example.org|
|Contact: FADEL SHALTOUT, MD|
|kasr elaini hospital (Cairo university)||Recruiting|
|Cairo, Egypt, 115431|
|Contact: MOUTAZ ELSHERBINI, MD (+2)01001588300 email@example.com|
|Principal Investigator: MOUTAZ ELSHERBINI, md|
|Principal Investigator:||MOUTAZ ELSHERBINI, MD||Assistant professor of obstetrics and gynecology|