Postmenopausal women Abnormal uterine bleeding Intrauterine lesion Cervical stenosis Office hysteroscopy Cervical dilation Hysteroscopic tissue removal system Mechanical dilator Postmenopause Pain Cervical stenosis Operative hysteroscopy Randomized controlled trial
Conditions
Interventions
Participants in this group will undergo cervical dilation using a hysteroscopic tissue removal system during office-based operative hysteroscopy. The procedure will be performed under direct hysterosc
Experimental Device,Active Comparator Device
Hysteroscopic Tissue Removal System,Hegar Dilator
Sponsors
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Eligibility
Sex/Gender
Female
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women, defined as women with amenorrhea for 12 consecutive months, undergoing office-based operative hysteroscopy at the Gynecologic Outpatient Department, Ramathibodi Hospital, with indications for office hysteroscopy including: 1.1 Endometrial polyp 1.2 Intrauterine lesion not exceeding 2 centimeters in size 1.3 Abnormal endometrium requiring endometrial biopsy for diagnosis 2. History of vaginal delivery 3. No previous cervical surgery 4. No previous pelvic radiation 5. Able to communicate and assess pain during and after the procedure 6. Willing to participate and provide written informed consent 7. No prior use of vaginal estrogen within 3 months before the procedure
Exclusion criteria
Exclusion criteria: 1. Requirement for operative hysteroscopy under general anesthesia 2. Contraindications to hysteroscopy, including active pelvic or genital tract infection at the time of the procedure, suspected cervical cancer, or advanced endometrial cancer 3. Assessed by the attending physician as unsuitable for office-based operative hysteroscopy, including patients with severe anxiety or medical conditions inappropriate for outpatient hysteroscopy 4. Inability to undergo diagnostic hysteroscopy from the beginning of the procedure 5. No intrauterine pathology identified after hysteroscopy requiring operative hysteroscopy 6. No requirement for cervical dilation after hysteroscopic evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain score During cervical dilation procedure Visual Analog scale (0-10) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain score during procedure Visual Analog scale (0-10),Pain score 15 minutes after procedure Visual Analog scale (0-10),Time time to access uterine cavity minutes,Time total procedure time minutes,Successful cervical dilation with access to uterine cavity During procedure Successful passage of the hysteroscope into the uterine cavity | — |
Countries
Thailand
Contacts
Public ContactMananya Angkaew
Department of Obstetrics and Gynecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University
Outcome results
None listed