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

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

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

Study Overview

• Status: Terminated
• Conditions: Polyps Uterus
• Intervention / Treatment: Procedure: Polypectomy without anesthesia or analgo-sedation

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth Hulier-Ammar, Dr; Phone Number: 0033146251175; Email: e.hulier-ammar@hopital-foch.com

Study Locations

• France
  • Ile-de-France
    • Suresnes, Ile-de-France, France, 92150
      • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Polypectomy without anesthesia or analgo-sedation; Patient will undergo polypectomy without anesthesia.

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Angeline FAVRE-INHOFER, Dr, Hopital Foch; Study Director: Marie Carbonnel, Dr, Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): May 23, 2022
• Study Completion (Actual): May 23, 2022

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2019_0026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No