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

ConditionHysteroscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with history of failure of office hysteroscopy

Disqualifiers

Pelvic inflammatory disease

Severe vaginal bleeding

Pregnancy

Allergy to lidocaine, prilocaine or diclofenac potassium

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound guided office hysteroscopy group

    Procedure/Surgery

    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

  • Conventional office hysteroscopy group

    Procedure/Surgery

    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.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Ultrasound guided office hysteroscopy groupActive comparator 1 intervention
Group B: Conventional office hysteroscopy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Success of office hysteroscopy [ ability to gain access of the hysteroscope into uterine cavity]

Percentage of successfully performed office hysteroscopy \[ = number of successful office hysteroscopies /total number of office hysteroscopies\]

Time frame
Immediately after the procedure

Secondary outcomes

1

Intensity of pain

Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)

Time frame
Immediately after the procedure

Other outcomes

Sponsors and contacts

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Cairo University

Lead sponsor

Bedaya Hospital

Collaborator