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

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.

Study Overview

• Status: Completed
• Conditions: Retained Products of Conception; Uterine Polyp
• Intervention / Treatment: Procedure: hysteroscopy

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Israel
  • Zrifin, Israel
    • Shamir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Women who have been diagnosed with a benign pathology (polyp or retained products of conception) in diagnostic hysteroscopy and are accepted for surgical hysteroscopy in a clinical setting (without anesthesia) for its removal.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with benign uterine findings (polyp / retained products of conception); Female patients undergoing diagnostic hysteroscopy with a diagnosis of uterine polyp or retained products of conception. These patients are then invited to a surgical office procedure without anaesthesia to remove these findings.	Procedure: hysteroscopy; Surgical hysteroscopy without anaesthesia for removal of uterine polyp / retained products of conception.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure completed successfully	Was the procedure completed - yes/no	Immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of VAS (pain scale) > 5 during procedure	VAS (Visual analogue scale 0-10, most painful 10) grading by the patient	Immediately after procedure
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
Acceptable procedure by the patient	Was the procedure acceptable by the patient (1-4 when 1 is most acceptable)	5 minutes after procedure
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

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 123456 (Innovate UK)

Drug and device information, study documents

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