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Recruiting NCT06637111

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

No phase Interventional Hysteroscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound guided office hysteroscopy group, Conventional office hysteroscopy group.
Who it may be relevant to
Registry conditions: Hysteroscopy. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure Ultrasound 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 (Kar
  • Procedure Conventional 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

Primary outcome measures

  • Success of office hysteroscopy [ ability to gain access of the hysteroscope into uterine cavity] [Time frame: Immediately after the procedure]
Secondary outcome measures (1)
  • Intensity of pain [Time frame: Immediately after the procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 2 centers
  • Faculty of medicine, Cairo university — Cairo
  • Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university — Cairo

Publications

  • Kresowik JD, Syrop CH, Van Voorhis BJ, Ryan GL. Ultrasound is the optimal choice for guidance in difficult hysteroscopy. Ultrasound Obstet Gynecol. 2012 Jun;39(6):715-8. doi: 10.1002/uog.11072. PMID 22173892

Identifiers

NCT: NCT06637111 · Ultrasonography/hysteroscopy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗