Clinical trial NCT05722028: Predictive Factors for Successful Operative Hysteroscopy Using Tissue Removal Device (TruClear System) Without Anesthesia
Official title: Predictive Factors for Successful Operative Hysteroscopy Using Tissue Removal Device (TruClear System) Without Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Polyp
Retained Products of Conception
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-02-10
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Procedure completed successfully
timeFrame: Immediately after procedure
Secondary outcomes:
measure: Prevalence of VAS (pain scale) > 5 during procedure
timeFrame: Immediately after procedure
measure: Prevalence of VAS (pain scale) > 5, five minutes after procedure
timeFrame: 5 minutes after procedure
measure: Acceptable procedure by the patient
timeFrame: 5 minutes after procedure
measure: Recommended procedure by the patient
timeFrame: 5 minutes after procedure
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Shamir medical center
Study officials:
References: