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

NCT06637111 | Recruiting DMC

• 1 other identifier: Ultrasonography/hysteroscopy
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Hysteroscopy

Keywords

Hysteroscopy; Ultrasound; Pain

Outcome Measures

Primary Outcomes (1)

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

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

  Immediately after the procedure

Secondary Outcomes (1)

• Intensity of pain

  Immediately after the procedure

Study Arms (2)

Ultrasound guided office hysteroscopy group

ACTIVE COMPARATOR

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. Transabdominal ultrasound will be used to guide the access of the hysteroscope to the uterine cavity

Procedure: Ultrasound guided office hysteroscopy group

Conventional office hysteroscopy group

ACTIVE COMPARATOR

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.

Procedure: Conventional office hysteroscopy group

Interventions

Ultrasound guided office hysteroscopy group PROCEDURE

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

Ultrasound guided office hysteroscopy group

Conventional office hysteroscopy group PROCEDURE

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.

Conventional office hysteroscopy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with history of failure of office hysteroscopy

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Bedaya Hospital: collaborator

Study Sites (2)

Faculty of medicine, Cairo university

Cairo, Egypt

RECRUITING

Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university

Cairo, Egypt

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Usama M Fouda

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Usama M Fouda, Prof.

CONTACT

01095401375; umfrfouda@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof,

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: October 30, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)