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

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.

Study Overview

• Status: Recruiting
• Conditions: Hysteroscopy
• Intervention / Treatment: Procedure: Ultrasound guided office hysteroscopy group; Procedure: Conventional office hysteroscopy group

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Usama M Fouda, Prof.; Phone Number: +2 01095401375; Email: umfrfouda@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university
    • Principal Investigator: Usama M Fouda, Prof
    • Contact: Usama M Fouda, Prof; Phone Number: 01095401375; Email: umfrfouda@kasralainy.edu.eg
  • Cairo, Egypt
    • Recruiting
    • Faculty of Medicine, Cairo University
    • Contact: Usama M Fouda, Prof.; Email: umfrfouda@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound guided office hysteroscopy group; 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; 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
Active Comparator: Conventional office hysteroscopy group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of pain	Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)	Immediately after the procedure

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Bedaya Hospital
• Investigators: Principal Investigator: Usama M Fouda, Cairo University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasound; Pain; Hysteroscopy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: Ultrasonography/hysteroscopy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No