Bipolar 15 Charrières Office Resectoscope : Polypectomy Without Anesthesia
- Conditions
- Polyps Uterus
- Interventions
- Procedure: Polypectomy without anesthesia or analgo-sedation
- Registration Number
- NCT04331652
- Lead Sponsor
- Hopital Foch
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 13
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Polypectomy without anesthesia or analgo-sedation Polypectomy without anesthesia or analgo-sedation Patient will undergo polypectomy without anesthesia.
- Primary Outcome Measures
Name Time Method Feasibility of polypectomy, with a mini-resectoscope of 15 bipolar careers, without general anesthesia or analgo-sedation 1 day (surgery) Use or not of general anesthesia or analgo-sedation during the surgery
- Secondary Outcome Measures
Name Time Method Patient satisfaction 4 months Patient satisfaction on a scale from 1 to 5 (1 meaning not satisfied at all and 5 very satisfied)
Pain assessment during and after surgery 1 day (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
Identification of factors influencing the success of the main criterion 4 months Correlations between preoperative data and main evaluation criterion (patient with or without analgo-sedation and or general anesthesia)
Capacity and clinical condition of the patient allowing her discharge 1 day (surgery) Capacity and clinical condition of the patient allowing her discharge 15 minutes, 1 hour and 2 hours after surgery
Post operative diagnostic hysteroscopy result 4 months Control diagnostic hysteroscopy: success if absence of visible intra-cavitary projection at the base of the excised polyp(s)
Trial Locations
- Locations (1)
Hopital Foch
🇫🇷Suresnes, Ile-de-France, France