OtosclerosisSPOCNCT03888079
Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia
An observational study of Otosclerosis and Otosclerosis Surgery, run by Rennes University Hospital at 1 site in France.
Trial summary
Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otosclerosis, Otosclerosis Surgery
- What is being tested?
- Local anesthetic and general anesthetic
- Type of treatment
- Injection or infusion
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2019to 21 Jun 2021
- Phase
- Observational
- 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
- All sexes
- Adult, Older adult
Study population: Patients suffering from otosclerosis who have surgical indication
Who may be able to join
- Patients older than 18 years suffering from otosclerosis who have surgical indication.
- Patients who want surgical treatment for their otosclerosis
- Clinic : Deafness with social prejudice and normal otoscopic exam
- Audiometric : conductive or mixed hearing loss with abolition of the aural reflex. Audiometric threshold more than 30decibel (dB) and air bone gap more important than 20dB.
- Pré operative scan in favor of otosclerosis
- Diagnosis confirmation during the surgery with stapes sclerotic's attachments to the oval window
Who cannot join
- History of ear surgery
- No medical objection to local anesthesia
- No medical objection to general anesthesia
- No medical objection to ear surgery
- No legal protection for adults
- No participation refusal
Trial locations and contacts
1 site in 1 country.
About this study
Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia.
Read the detailed description
The care system will not differ from the usually treatment of patients. Patients will decided about the type of anesthesia (local or general) after detailed description of both procedures.
All operations will be performed by the same surgeon and the same basic surgical technique.
The only difference is that patients included in thi study will have to complete a satisfactory survey 10 days after surgery and a GBI questionnaire 3 months after surgery, during the post operative consultations .
- Conditions
- Otosclerosis, Otosclerosis Surgery
- Being tested
- Local anesthetic, general anesthetic
- Keywords
- Otosclerosis, otosclerosis surgery, local anesthesia, general anesthesia, comfort assessment, Glasgow Benefit Inventory questionnaire, hearing results
- Medical subject headings
- Otosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anestheticDrug
1% or 2% lidocaine with 1:100,000 epinephrine, augmented by intravenous sedation and analgesia
general anestheticDrug
Endotracheal intubation, intravenous narcotic agents, and inhaled agents
| Study group | Role | What they receive |
|---|---|---|
| Local anesthetic | Patients who chose local anesthesia for their surgery Receives: Drug: Local anesthetic | |
| General anesthetic | Patients who chose general anesthesia for their surgery Receives: Drug: general anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual comfort scale (EVA type ruler)
respondents specify their level of comfort during the surgery by indicating a position along a continuous line between two end-points : Minimum score is 0 (no comfort) and maximum is 10 (very comfortable) during surgery
Measured: 10 days after surgery
Secondary outcomes (1)
Glasgow Benefit Inventory questionnaire GBI
Glasgow Benefit Inventory questionnaire GBI (GBI, Robinson et al. 1996).
- The Glasgow Benefit Inventory (GBI) is a measure of patient benefit developed especially for otorhinolaryngological (ORL) interventions. 18 items in 3 categories defined by social, psychological, and physical perceptions of well-being
- Responses are based on a 5-point Likert scale, ranging from a large deterioration in health status (1) to a large improvement (5).
- The total GBI score is then calculated from an average of the Likert scores to give equal weight to each question. The average (1 5) is subtracted by 3 (no change), and the result is multiplied by 50 to produce a GBI score that ranges from 100 (maximum detriment after surgery) to 100 (maximum improvement after the intervention). A GBI score of zero is neutral and indicates no improvement or detriment from the intervention.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start11 Jan 2019
- Primary completion3 Mar 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Godey, PH-PD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888079
- Sponsor's protocol ID
- 35RC18_3061_SPOC
- Acronym
- SPOC
- Status last verified
- Mar 2019
- First submitted
- 4 Feb 2019
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia
- ClinicalTrials.gov ID
- NCT03888079
- Acronym / sponsor ID
- SPOC / 35RC18_3061_SPOC
- Conditions
- Otosclerosis, Otosclerosis Surgery
- Keywords
- Otosclerosis, otosclerosis surgery, local anesthesia, general anesthesia, comfort assessment, Glasgow Benefit Inventory questionnaire, hearing results
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 25 Mar 2019 (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.
Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia.
Detailed description
The care system will not differ from the usually treatment of patients. Patients will decided about the type of anesthesia (local or general) after detailed description of both procedures.
All operations will be performed by the same surgeon and the same basic surgical technique.
The only difference is that patients included in thi study will have to complete a satisfactory survey 10 days after surgery and a GBI questionnaire 3 months after surgery, during the post operative consultations .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthetic | – | Drug: Local anestheticPatients who chose local anesthesia for their surgery |
| General anesthetic | – | Drug: general anestheticPatients who chose general anesthesia for their surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from otosclerosis who have surgical indication
Key inclusion criteria (6 listed)
- Patients older than 18 years suffering from otosclerosis who have surgical indication.
- Patients who want surgical treatment for their otosclerosis
- Clinic : Deafness with social prejudice and normal otoscopic exam
- Audiometric : conductive or mixed hearing loss with abolition of the aural reflex. Audiometric threshold more than 30decibel (dB) and air bone gap more important than 20dB.
- Pré operative scan in favor of otosclerosis
Key exclusion criteria (6 listed)
- History of ear surgery
- No medical objection to local anesthesia
- No medical objection to general anesthesia
- No medical objection to ear surgery
- No legal protection for adults
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 |
|---|---|---|
| Local anesthetic1% or 2% lidocaine with 1:100,000 epinephrine, augmented by intravenous sedation and analgesia | Drug | Local anesthetic |
| general anestheticEndotracheal intubation, intravenous narcotic agents, and inhaled agents | Drug | General anesthetic |
Primary outcome
Visual comfort scale (EVA type ruler)
Time frame: 10 days after surgery
respondents specify their level of comfort during the surgery by indicating a position along a continuous line between two end-points : Minimum score is 0 (no comfort) and maximum is 10 (very comfortable) during surgery
1 secondary outcome
Glasgow Benefit Inventory questionnaire GBI
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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Surgical and Audiological Outcomes of Endoscopic Stapes Surgery
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RecruitingObservational study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Otosclerosis of Middle Ear, Bone Density
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.
Benoit Godey, PH-PD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otosclerosis and Otosclerosis Surgery, run by Rennes University Hospital 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 6 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: finished, as of the sponsor's last update on 5 Apr 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual comfort scale (EVA type ruler) (time frame: 10 days after 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 5 Apr 2022.