Clinical trial NCT04331652: Bipolar 15 Charrières Office Resectoscope : Polypectomy Without Anesthesia
Official title: Bipolar 15 Charrières (Ch.) Office Resectoscope : Polypectomy Without Anesthesia - Prospective Evaluation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Polyps Uterus
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of polypectomy, with a mini-resectoscope of 15 bipolar careers, without general anesthesia or analgo-sedation
timeFrame: 1 day (surgery)
Secondary outcomes:
measure: Pain assessment during and after surgery
timeFrame: 1 day (surgery)
measure: Capacity and clinical condition of the patient allowing her discharge
timeFrame: 1 day (surgery)
measure: Patient satisfaction
timeFrame: 4 months
measure: Post operative diagnostic hysteroscopy result
timeFrame: 4 months
measure: Identification of factors influencing the success of the main criterion
timeFrame: 4 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Ile-de-France
Study officials:
affiliation: Hopital Foch
name: Angeline FAVRE-INHOFER, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Foch
name: Marie Carbonnel, Dr
role: STUDY_DIRECTOR
References: