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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hysteroscopy | Procedure | Surgical hysteroscopy without anaesthesia for removal of uterine polyp / retained products of conception. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedure completed successfully | Was the procedure completed - yes/no | Immediately after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of VAS (pain scale) > 5 during procedure | VAS (Visual analogue scale 0-10, most painful 10) grading by the patient | Immediately after procedure |
| Prevalence of VAS (pain scale) > 5, five minutes after procedure |
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Inclusion Criteria:
Exclusion Criteria:
Any indication for performing the procedure under anesthesia in an operating room, such as:
The lack of response to participate in the study
A known diagnosis of malignancy from a previous sample of the polyp or endometrium
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shamir medical center | Zrifin | Israel |
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| ID | Term |
|---|---|
| D015907 | Hysteroscopy |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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VAS (Visual analogue scale 0-10, most painful 10) grading by the patient
| 5 minutes after procedure |
| Acceptable procedure by the patient | Was the procedure acceptable by the patient (1-4 when 1 is most acceptable) | 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) | 5 minutes after procedure |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |