Bipolar 15 Charrières Office Resectoscope : Polypectomy Without Anesthesia

Study Overview
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Brief Summary
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This study aimed to the feasibility of polypectomy without anesthesia using a 15 Ch. resectoscope in women with uterine polyps.

Detailed Description
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Endometrial polyps are frequent gynecological pathologies leading to metrorrhagia, infertility, miscarriages and the risk of transformation into malignant pathology. The discovery of an endometrial polyp requires its removal. 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.

Official Title
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Bipolar 15 Charrières (Ch.) Office Resectoscope : Polypectomy Without Anesthesia - Prospective Evaluation

Conditions
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Polyps Uterus

Intervention / Treatment
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* Procedure: Polypectomy without anesthesia or analgo-sedation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients aged 18 or over 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: Pregnant or lactating patient 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polypectomy without anesthesia or analgo-sedation<br>Patient will undergo polypectomy without anesthesia. | Procedure: Polypectomy without anesthesia or analgo-sedation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of polypectomy, with a mini-resectoscope of 15 bipolar careers, without general anesthesia or analgo-sedation | Use or not of general anesthesia or analgo-sedation during the surgery | 1 day (surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment during and after surgery | Pain assessment on a scale from 0 to 10; before surgery, during surgery (during the introduction of the hysteroscope into the uterine cavity, during the possible placement of a speculum and during the removal of the polyp at the handle) then 15 minutes, 1 hour and 2 hours post-operative | 1 day (surgery) | 
| Capacity and clinical condition of the patient allowing her discharge | Capacity and clinical condition of the patient allowing her discharge 15 minutes, 1 hour and 2 hours after surgery | 1 day (surgery) | 
| Patient satisfaction | Patient satisfaction on a scale from 1 to 5 (1 meaning not satisfied at all and 5 very satisfied) | 4 months | 
| Post operative diagnostic hysteroscopy result | Control diagnostic hysteroscopy: success if absence of visible intra-cavitary projection at the base of the excised polyp(s) | 4 months | 
| Identification of factors influencing the success of the main criterion | Correlations between preoperative data and main evaluation criterion (patient with or without analgo-sedation and or general anesthesia) | 4 months |