Predictive Factors for Successful Operative Hysteroscopy Using Tissue Removal Device (TruClear System) Without Anesthesia
NCT ID: NCT05722028
Last Updated: 2024-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2022-08-01
2023-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
hysteroscopy
Surgical hysteroscopy without anaesthesia for removal of uterine polyp / retained products of conception.
Interventions
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hysteroscopy
Surgical hysteroscopy without anaesthesia for removal of uterine polyp / retained products of conception.
Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
FEMALE
No
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Maayan Gal
investigator
Locations
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Shamir medical center
Zrifin, , Israel
Countries
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Other Identifiers
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123456
Identifier Type: -
Identifier Source: org_study_id
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