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Ultrasound Guidance of Office Hysteroscopy in Patients With History of Failure of Office Hysteroscopy Due to Cervical Stenosis.

Ultrasound Guidance of Office Hysteroscopy in Patients With History of Failure of Office Hysteroscopy Due to Cervical Stenosis.A Randomized Controlled Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06637111
Enrollment
58
Registered
2024-10-15
Start date
2024-10-30
Completion date
2025-04-30
Last updated
2025-04-30

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

Conditions

Hysteroscopy

Keywords

Hysteroscopy, Ultrasound, Pain

Brief summary

The study is conducted to assess whether ultrasound guidance can facilitate the access of the office hysteroscope into the uterine cavity of patients with previous failure of office hysteroscopy due to cervical stenosis.

Interventions

PROCEDUREUltrasound guided office hysteroscopy group

One hour before office hysteroscopy, 100 mg of diclofenac potassium will be administered per orem. The patients will be asked to drink about one liter of water and to avoid urination before the procedure Moreover, a few minutes prior to the office hysteroscopy, 3 ml of 5% lidocaine and prilocaine topical cream will be introduced into the endocervical canal. All procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures. A 5 Fr grasper and 5 Fr scissors will be used to widen the stenotic internal or external ostia. Transabdominal ultrasound will be used to guide the access of the hysteroscope to the uterine cavity

PROCEDUREConventional office hysteroscopy group

One hour before office hysteroscopy, 100 mg of diclofenac potassium will be administered per orem . The patients will be asked to drink about one liter of water and to avoid urination before the procedure Moreover, a few minutes prior to the office hysteroscopy, 3 ml of 5% lidocaine and prilocaine topical cream will be introduced into the endocervical canal. All the procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures. A 5 Fr grasper and 5 Fr scissors will be used to widen the stenotic internal or external ostia.

Sponsors

Bedaya Hospital
CollaboratorOTHER
Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients with history of failure of office hysteroscopy

Exclusion criteria

* Pelvic inflammatory disease * Severe vaginal bleeding * Pregnancy * Allergy to lidocaine, prilocaine or diclofenac potassium

Design outcomes

Primary

MeasureTime frameDescription
Success of office hysteroscopy [ ability to gain access of the hysteroscope into uterine cavity]Immediately after the procedurePercentage of successfully performed office hysteroscopy \[ = number of successful office hysteroscopies /total number of office hysteroscopies\]

Secondary

MeasureTime frameDescription
Intensity of painImmediately after the procedureMeasured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)

Countries

Egypt

Contacts

Primary ContactUsama M Fouda, Prof.
umfrfouda@kasralainy.edu.eg01095401375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026