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A randomized controlled trial study of pain during cervical dilation by traditional mechanical dilator versus Hysteroscopic cervical morcellation during office operative hysteroscopy

A randomized controlled trial study of pain during cervical dilation by traditional mechanical dilator versus Hysteroscopic cervical morcellation during office operative hysteroscopy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250223003
Enrollment
56
Registered
2025-02-23
Start date
2024-12-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain score after complete cervical dilation before proceeding to operative hysteroscopy Hysteroscopic tissue removal system, hegar dilator, hysteroscopic morcellator, cervical dilation, pain score, office operative hysteroscopy

Interventions

Using Hysteroscopic morcellator device to dilate the cervix before proceeding with operative hysteroscopy,Using Hegar dilator to dilate the cervix before proceeding with operative hysteroscopy
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Hysteroscopic morcellator,Hegar dilator

Sponsors

Faculty of Medicine Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Women undergoing office hysteroscopy at the gynecology outpatient department of Ramathibodi Hospital with indications requiring hysteroscopic surgery, including: endometrial polyps, submucosal fibroids not more than 3 cm in size, intrauterine adhesions, uterine septum, intrauterine foreign bodies, endometrial abnormalities requiring endometrial biopsy for diagnosis 2. Women who can tolerate pelvic examination 3. nulliparous women or women with previous cesarean delivery only 4. women not desiring future fertility 5. Willingness to participate in the study and provide informed consent

Exclusion criteria

Exclusion criteria: 1. Women who request for hysteroscopic surgery under general anesthesia 2. Women who have contraindications for hysteroscopy, including pregnancy, pelvic or genital tract infections at the time of the procedure, or suspected invasive cervical or endometrial cancer 3. Assessment by the hysteroscopic surgeon indicating unsuitability for outpatient hysteroscopy, such as patients with high anxiety levels or conditions inappropriate for outpatient procedures 4. Women who presence of cervical stenosis, defined as diameter less than 2.5 mm 5. Prior administration of misoprostol before the procedure 6. Postmenopausal status, defined as the absence of menstrual bleeding for more than one year

Design outcomes

Primary

MeasureTime frame
Pain score Immediate after completion of cervical dilation Visual Analog Scale

Secondary

MeasureTime frame
Satisfaction After office hysteroscopy Questionaire,Cervical dilation time total time from start to complete cervical dilation procedure minutes,Success rate of hysteroscopic instrument insertion through the cervix after passing hysteroscopic instrument through cervix percentage,Complications related to cervical dilation prior to hysteroscopy detection of complication includingexcessive bleeding, vasovagal reaction, uterine perforation, and creation of a false passage during cervical dilation percentage

Countries

Thailand

Contacts

Public ContactNantiya Chuang

Faculty of Medicine Ramathibodi Hospital, Mahidol University

nantiya.pr@gmail.com0653962690

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026