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

Recruiting

• Conditions: Uterine Polyp; Retained Products of Conception
• Interventions: Procedure: hysteroscopy

• Registration Number: NCT05722028
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2023-01-29
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-08
• Study First Posted: 2023-02-10
• Last Update Posted: 2023-02-10
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with benign uterine findings (polyp / retained products of conception)	hysteroscopy	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.

Primary Outcome Measures

Name	Time	Method
Procedure completed successfully	Immediately after procedure	Was the procedure completed - yes/no

Secondary Outcome Measures

Name	Time	Method
Prevalence of VAS (pain scale) > 5, five minutes after procedure	5 minutes after procedure	VAS (Visual analogue scale 0-10, most painful 10) grading by the patient
Acceptable procedure by the patient	5 minutes after procedure	Was the procedure acceptable by the patient (1-4 when 1 is most acceptable)
Recommended procedure by the patient	5 minutes after procedure	Would the patient recommend her acquittance the procedure in this outline (1-5, most recommended 5) aquitance (1-5)
Prevalence of VAS (pain scale) > 5 during procedure	Immediately after procedure	VAS (Visual analogue scale 0-10, most painful 10) grading by the patient

Trial Locations

Locations (1)

Shamir medical center; 🇮🇱 Zrifin, Israel