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HSC: Bipolar 15 Charrières Office Resectoscope : Polypectomy Without Anesthesia

Sponsor
Hopital Foch (Other)
Overall Status
Recruiting
CT.gov ID
NCT04331652
Collaborator
(none)
48
Enrollment
1
Location
1
Arm
23.8
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Polypectomy without anesthesia or analgo-sedation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Bipolar 15 Charrières (Ch.) Office Resectoscope : Polypectomy Without Anesthesia - Prospective Evaluation
Actual Study Start Date :
Dec 14, 2020
Anticipated Primary Completion Date :
Dec 8, 2022
Anticipated Study Completion Date :
Dec 8, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. Patient satisfaction [4 months]

    Patient satisfaction on a scale from 1 to 5 (1 meaning not satisfied at all and 5 very satisfied)

  4. 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)

  5. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital Foch Suresnes Ile-de-France France 92150

Sponsors and Collaborators

  • Hopital Foch

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT04331652
Other Study ID Numbers:
  • 2019_0026
First Posted:
Apr 2, 2020
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Anesthetics

Study Results

No Results Posted as of Aug 3, 2022