Bipolar 15 Charrières Office Resectoscope : Polypectomy Without Anesthesia
NCT ID: NCT04331652
Last Updated: 2023-03-01
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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TERMINATED
NA
13 participants
INTERVENTIONAL
2020-12-14
2022-05-23
Brief Summary
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Detailed Description
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The treatment of endometrial polyps is conventionally carried out by hysteroscopic resection under general anesthesia with a bipolar resector of 22 Charrières (Ch) or more after dilation of the uterine cervix in the operating room.
Following the recent appearance of a 15 Ch. bipolar mini-resectoscope, it seems that uterine dilation and anesthesia could be avoided by reducing the caliber of the instrument.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Polypectomy without anesthesia or analgo-sedation
Patient will undergo polypectomy without anesthesia.
Polypectomy without anesthesia or analgo-sedation
Premedication: paracetamol 1g oral. Patient will undergo polypectomy without anesthesia. During the procedure, pain will be monitored using a pain assessment scale from 0 to 10 (0 meaning no pain and 10 meaning maximum pain imaginable). At any time, if the patient express a pain strictly superior to 4 an analgo-sedation will be proposed and/or general anesthesia.
Pulse and blood pressure will be monitored. Assessment of patient satisfaction after the intervention.
Interventions
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Polypectomy without anesthesia or analgo-sedation
Premedication: paracetamol 1g oral. Patient will undergo polypectomy without anesthesia. During the procedure, pain will be monitored using a pain assessment scale from 0 to 10 (0 meaning no pain and 10 meaning maximum pain imaginable). At any time, if the patient express a pain strictly superior to 4 an analgo-sedation will be proposed and/or general anesthesia.
Pulse and blood pressure will be monitored. Assessment of patient satisfaction after the intervention.
Eligibility Criteria
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Inclusion Criteria
* Patients with 1 to 2 endometrial polyps
* Polyps diagnosed by ultrasound and / or diagnostic hysteroscopy following a check-up for menometrorrhagia, infertility or during a check-up
* Polyps measuring less than 3 cm
* Have signed a consent form
* Be affiliated with a Health Insurance plan.
Exclusion Criteria
* Cervical stenosis
* Patient having more than 2 polyps
* Polyps measuring 3 cm or more
* Malignant cells on histology
* Associated indication of endometrectomy or other endo-uterine gesture
* Hypersensitivity to remifentanil or to other fentanyl derivatives or to any of the excipients of the specialty used
* Hypersensitivity to propofol or to any of the excipients of the specialty used
* Cardiac pathology
* Diaphragmatic hernia
* Morbid obesity (BMI\> 35)
* Invasive cervical cancer
* Chronic obstructive pulmonary disease
* Patient presenting a strictly greater than 4 on a pain scale (from 0 to 10) during a diagnostic hysteroscopy
* Does not speak and / or understand French
* Be deprived of liberty or under guardianship.
18 Years
FEMALE
No
Sponsors
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Hopital Foch
OTHER
Responsible Party
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Principal Investigators
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Angeline FAVRE-INHOFER, Dr
Role: PRINCIPAL_INVESTIGATOR
Hopital Foch
Marie Carbonnel, Dr
Role: STUDY_DIRECTOR
Hopital Foch
Locations
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Hopital Foch
Suresnes, Île-de-France Region, France
Countries
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Other Identifiers
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2019_0026
Identifier Type: -
Identifier Source: org_study_id
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