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Completed

NCT Number: NCT05722028

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.

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Key information

Conditions

Uterine Polyp Retained Products of Conception

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Shamir medical center

Zrifin, Israel

Who can participate

Only the study team can determine whether someone qualifies for participation.

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:
  • Medical background requiring operation in an operating room.
  • Personal / mental background requiring procedure under general anesthesia.
  • Cervical stenosis
  • Previous failure to remove the finding in a procedure without anesthesia
  • 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

Treatment and study plan

Hysteroscopy

Procedure

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

Primary outcomes

  1. Procedure completed successfully

    Time frame: Immediately after procedure

    Was the procedure completed - yes/no

Secondary outcomes

  1. Prevalence of VAS (pain scale) > 5 during procedure

    Time frame: Immediately after procedure

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

  2. Prevalence of VAS (pain scale) > 5, five minutes after procedure

    Time frame: 5 minutes after procedure

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

  3. Acceptable procedure by the patient

    Time frame: 5 minutes after procedure

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

  4. Recommended procedure by the patient

    Time frame: 5 minutes after procedure

    Would the patient recommend her acquittance the procedure in this outline (1-5, most recommended 5) aquitance (1-5)

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2023
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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