Polyps UterusHSCNCT04331652
Bipolar 15 Charrières Office Resectoscope : Polypectomy Without Anesthesia
A study testing Polypectomy without anesthesia or analgo-sedation in people with Polyps Uterus, run by Hopital Foch at 1 site in France.
Trial summary
This study aimed to the feasibility of polypectomy without anesthesia using a 15 Ch. resectoscope in women with uterine polyps. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Polyps Uterus
- What is being tested?
- Polypectomy without anesthesia or analgo-sedation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2020to 23 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Polyps Uterus
- Being tested
- Polypectomy without anesthesia or analgo-sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypectomy without anesthesia or analgo-sedationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Polypectomy without anesthesia or analgo-sedation | Experimental | Patient will undergo polypectomy without anesthesia. Receives: Procedure: Polypectomy without anesthesia or analgo-sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day (surgery)
Secondary outcomes (5)
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
Measured: 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
Measured: 1 day (surgery)
Patient satisfaction
Patient satisfaction on a scale from 1 to 5 (1 meaning not satisfied at all and 5 very satisfied)
Measured: 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)
Measured: 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)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start14 Dec 2020
- Primary completion23 May 2022
- Study completion23 May 2022
Why it stopped: change of practices
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyps UterusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angeline FAVRE-INHOFER, Dr, Principal investigator, Hopital FochMarie Carbonnel, Dr, Study director, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331652
- Sponsor's protocol ID
- 2019_0026
- Acronym
- HSC
- Status last verified
- Feb 2023
- First submitted
- 31 Mar 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar 15 Charrières (Ch.) Office Resectoscope : Polypectomy Without Anesthesia - Prospective Evaluation
- ClinicalTrials.gov ID
- NCT04331652
- Acronym / sponsor ID
- HSC / 2019_0026
- Conditions
- Polyps Uterus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change of practices
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polypectomy without anesthesia or analgo-sedation | Experimental | Procedure: Polypectomy without anesthesia or analgo-sedationPatient will undergo polypectomy without anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- Pregnant or lactating patient
- Cervical stenosis
- Patient having more than 2 polyps
- Polyps measuring 3 cm or more
- Malignant cells on histology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polypectomy without anesthesia or analgo-sedationPremedication: 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. | Procedure or surgery | Polypectomy without anesthesia or analgo-sedation |
Primary outcome
Feasibility of polypectomy, with a mini-resectoscope of 15 bipolar careers, without general anesthesia or analgo-sedation
Time frame: 1 day (surgery)
Use or not of general anesthesia or analgo-sedation during the surgery
5 secondary outcomes
Pain assessment during and after surgery
Time frame: 1 day (surgery)
Capacity and clinical condition of the patient allowing her discharge
Time frame: 1 day (surgery)
Patient satisfaction
Time frame: 4 months
Post operative diagnostic hysteroscopy result
Time frame: 4 months
Identification of factors influencing the success of the main criterion
Time frame: 4 months
Results and safety
The study was stopped early (reason given: change of practices). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angeline FAVRE-INHOFER, Dr principal investigator
Hopital Foch
Marie Carbonnel, Dr study director
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polypectomy without anesthesia or analgo-sedation in people with Polyps Uterus, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: change of practices). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of polypectomy, with a mini-resectoscope of 15 bipolar careers, without general anesthesia or analgo-sedation (time frame: 1 day (surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.