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

N/ACompletedNCT05722028

Assaf-Harofeh Medical Center70 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Uterine Polyp Retained Products of Conception

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Procedure completed successfully

Was the procedure completed - yes/no

Time frame: Immediately after procedure

Secondary Outcomes

Prevalence of VAS (pain scale) > 5 during procedure

VAS (Visual analogue scale 0-10, most painful 10) grading by the patient

Time frame: 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

Time frame: 5 minutes after procedure

Acceptable procedure by the patient

Was the procedure acceptable by the patient (1-4 when 1 is most acceptable)

Time frame: 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)

Time frame: 5 minutes after procedure

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes