Bipolar 15 Charrières Office Resectoscope : Polypectomy Without Anesthesia (HSC)

Hopital Foch

Status: Terminated

Conditions: Polyps Uterus

Treatments: Procedure: Polypectomy without anesthesia or analgo-sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT04331652

2019_0026

Details and patient eligibility

About

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

Full description

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.

Enrollment: 13 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Polypectomy without anesthesia or analgo-sedation

Experimental group

Description:

Patient will undergo polypectomy without anesthesia.

Treatment:

Procedure: Polypectomy without anesthesia or analgo-sedation