Predictive Factors for Successful Operative Hysteroscopy Using Tissue Removal Device (TruClear System) Without Anesthesia

Retained Products of Conception Clinical Trial

Official title:

Predictive Factors for Successful Operative Hysteroscopy Using Tissue Removal Device (TruClear System) Without Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722028
• Other study ID #: 123456
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2023
• Source: Assaf-Harofeh Medical Center
• Contact: Noam Smorgick, Prof
• Phone: +97289542512
• Email: nsmorgik[@]shamir.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: Small-diameter operative hysteroscopes may allow to perform operative hysteroscopy without general anesthesia in selected patients. One of these instruments is the tissue removal device (TRD), which resects and removes intrauterine pathology such as endometrial polyps and retained products of conception (RPOC) with a diameter of ¬6 mm.

Objective: To assess the success rate and intraoperative pain of patients undergoing operative hysteroscopy without anesthesia with the TRD (TruClear Elite Mini-Hysteroscope) for removal of endometrial polyps or RPOC.

Methods: Prospective observational study. Participation in the study was offered to patients diagnosed with uterine polyps or RPOC on office diagnostic hysteroscopy. The patients filled out a digital questionnaire before and after the operation. A successful procedure was defined as complete hysteroscopic removal of the uterine pathology using the TruClear system. Oral 400 mcg misoprostol 12 hours before the procedure was prescribed for cervical ripening.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of polyp or retained products of conception in diagnostic hysteroscopy.

• Medical need to remove the finding according to accepted criteria.

• Patient's consent to the removal of the finding in a procedure without anesthesia.

• Patient's consent to participate in the study.

Exclusion Criteria:

• Any indication for performing the procedure under anesthesia in an operating room, such as:

1. Medical background requiring operation in an operating room.

2. Personal / mental background requiring procedure under general anesthesia.

3. Cervical stenosis

4. Previous failure to remove the finding in a procedure without anesthesia

5. Lack of response to performing the operation without anesthesia

• The lack of response to participate in the study

• A known diagnosis of malignancy from a previous sample of the polyp or endometrium

Related Conditions & MeSH terms

• Retained Products of Conception

Intervention

Procedure:
• hysteroscopy
Surgical hysteroscopy without anaesthesia for removal of uterine polyp / retained products of conception.

Locations

Country	Name	City	State
Israel	Shamir medical center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure completed successfully	Was the procedure completed - yes/no	Immediately after procedure
Secondary	Prevalence of VAS (pain scale) > 5 during procedure	VAS (Visual analogue scale 0-10, most painful 10) grading by the patient	Immediately after procedure
Secondary	Prevalence of VAS (pain scale) > 5, five minutes after procedure	VAS (Visual analogue scale 0-10, most painful 10) grading by the patient	5 minutes after procedure
Secondary	Acceptable procedure by the patient	Was the procedure acceptable by the patient (1-4 when 1 is most acceptable)	5 minutes after procedure
Secondary	Recommended procedure by the patient	Would the patient recommend her acquittance the procedure in this outline (1-5, most recommended 5) aquitance (1-5)	5 minutes after procedure