SPOC: Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

Sponsor
Rennes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03888079
Collaborator
(none)
103
1
29.3
3.5

Study Details

Study Description

Brief Summary

Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia.

Condition or Disease Intervention/Treatment Phase
  • Drug: Local anesthetic
  • Drug: general anesthetic

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

Study Type:
Observational
Actual Enrollment :
103 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia
Actual Study Start Date :
Jan 11, 2019
Actual Primary Completion Date :
Mar 3, 2021
Actual Study Completion Date :
Jun 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Local anesthetic

Patients who chose local anesthesia for their surgery

Drug: Local anesthetic
1% or 2% lidocaine with 1:100,000 epinephrine, augmented by intravenous sedation and analgesia

General anesthetic

Patients who chose general anesthesia for their surgery

Drug: general anesthetic
Endotracheal intubation, intravenous narcotic agents, and inhaled agents

Outcome Measures

Primary Outcome Measures

  1. Visual comfort scale (EVA type ruler) [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

Secondary Outcome Measures

  1. Glasgow Benefit Inventory questionnaire GBI [3 months after surgery]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion criteria:
  • 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.

  • PrĂ© operative scan in favor of otosclerosis

  • Diagnosis confirmation during the surgery with stapes sclerotic's attachments to the oval window

Exclusion criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Universitaire de Rennes Rennes France 35033

Sponsors and Collaborators

  • Rennes University Hospital

Investigators

  • Principal Investigator: Benoit Godey, PH-PD, Rennes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT03888079
Other Study ID Numbers:
  • 35RC18_3061_SPOC
First Posted:
Mar 25, 2019
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rennes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022