Bipolar 15 Charrières Office Resectoscope : Polypectomy Without Anesthesia

Polyps Uterus Clinical Trial

— HSC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04331652
• Other study ID #: 2019_0026
• Status: Terminated
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: May 23, 2022

Study information

• Verified date: February 2023
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: May 23, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Polyps Uterus

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Patient satisfaction	Patient satisfaction on a scale from 1 to 5 (1 meaning not satisfied at all and 5 very satisfied)	4 months
Secondary	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
Secondary	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