- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03809312
The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp
The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp: A Randomized, Double-blind Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The severity of the disease will be evaluated preoperatively according to the SNOT-22 score, the visual analogue scale of nasal symptoms, the Lund-Mackay score on the CT-scan and the Modified Lund-Kennedy endoscopic score (sinusoscopy will be recorded). Relevant demographics and medical history of participants will also be collected preoperatively.
The extension of the CES and intraoperative findings will be noted. Patients who have an infection during the procedure (pus with positive culture) will be excluded from the study. During the surgery, 4 groups will be formed as described in the figure below. Patients will be divided according to the presence or absence of polyps at the endoscopy and randomized in one of the 2 groups by the pharmacy of the CHU of Quebec. This will provide either a prescription of Clavulin 875 mg per os twice daily for 10 days, or a placebo of similar visual appearance in the same dosage. A bioabsorbable dressing (NasoPore, Stryker) will be positioned at the mid-meatus level at the end of the procedure. Nasal irrigations of saline solution will be prescribed post-operatively (qid for 1 month) as well as intra-nasal corticosteroids bid after 1 week (usual treatment). The addition of systemic corticosteroids will be left to the judgment of the surgeon, noted and analyzed as a confounding factor.
Follow-up will be done at 2 weeks, 1 month, 3 months and 6 months post-surgery. Patients will have to complete the SNOT-22 quality of life score and the visual similar scale of nasal symptoms at each visit. Sinusoscopy will be recorded at scheduled visits postoperatively. A single blind evaluator (to limit inter-rater differences) will analyze the video recordings to establish the modified Lund-Kennedy endoscopic score for each patient. Middle-meat secretion culture will be performed if pus is present during sinusoscopy and an antibiotic prescribed if needed. The patient will have to fill in a diary of other medications (analgesics, narcotics, anti-inflammatories) as well as a diary of side effects that will be collected at the visit of a post-operative month.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Simon-Pierre Harvey-Bolduc, DR
- Phone Number: 418-455-6167
- Email: simon-pierre.harvey-bolduc.1@ulaval.ca
Study Contact Backup
- Name: Marie-Noëlle Corriveau
- Email: marie-noelle.corriveau@fmed.ulaval.ca
Study Locations
-
-
-
Québec, Canada, G1H0C2
- Recruiting
- Simon-Pierre Harvey-Bolduc
-
Contact:
- Simon-Pierre Harvey-Bolduc, DR
- Phone Number: 418-455-6167
- Email: simon-pierre.harvey-bolduc.1@ulaval.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years old and over able to consent
- Patients with chronic rhinosinusitis and failure to maximal medical treatment
- Endoscopic sinus surgery with at least one of the following: maxillary antrostomy, ethmoidectomy, sphenoidotomy and / or frontal sinusotomy
Exclusion Criteria:
- Antibiotherapy less than 2 weeks before the intervention
- Penicillin allergy
- Inability to establish follow-up
- Open sinus surgery or associated septorhinoplasty (simple septoplasty is not considered an exclusion criterion)
- Immunodeficiency
- Cystic fibrosis of the pancreas
- Pregnancy
- odontogenic sinusitis
- Fungal sinusitis
- Diabetic
- Ciliary dyskinesia
- Sinus neoplasia
- Patient requiring antibiotic prophylaxis for endocarditis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Clavulin group with polyps
Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who have polyps in the surgery
|
Amoxicillin / Clavulanic acid 875 mg / 125 mg BID x 10 days
|
Placebo Comparator: Placebo group with polyps
Group who will receive placebo after the endoscopic sinus surgery in prophylactic and who have polyps in the surgery
|
Placebos BID x 10 days
|
Active Comparator: Clavulin group without polyps
Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who haven't polyps in the surgery
|
Amoxicillin / Clavulanic acid 875 mg / 125 mg BID x 10 days
|
Placebo Comparator: Placebo group without polyps
Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who haven't polyps in the surgery
|
Placebos BID x 10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Lund-Kennedy endoscopic score
Time Frame: 3 months
|
The modified Lund-Kennedy score is an endoscopic score that measures sinus involvement during endoscopy.
It is divided into 2 nostrils.
For each nostril, it has a score of 0 to 2 for the presence of polyp, edema and flow.
The score is therefore 0 to 6 for each nostril for a maximum of 12.
The higher the score, the more severe is the condition
|
3 months
|
Quality of life of patients SNOT-22
Time Frame: 3 months
|
The SNOT-22 score is a quality of life score.
It contains 22 sinus symptoms.
Each of the symptoms is scored from 0 to 5, with 0 being no problem and 5 being a severe problem.
The SNOT-22 is a score of 0 to 110, the higher the score, the more severe the disease.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Lund-Kennedy endoscopic score
Time Frame: 1 months
|
The modified Lund-Kennedy score is an endoscopic score that measures sinus involvement during endoscopy.
It is divided into 2 nostrils.
For each nostril, it has a score of 0 to 2 for the presence of polyp, edema and flow.
The score is therefore 0 to 6 for each nostril for a maximum of 12.
The higher the score, the more severe is the condition
|
1 months
|
Rate of infection
Time Frame: 3 months
|
Evaluate the rate of infection after endoscopic sinus surgery with or without prophylactic antibiotics, defined according to the criteria of acute bacterial rhinosinusitis.
|
3 months
|
VAS symptoms
Time Frame: 3 months
|
The visual analogue scale is a scale containing 6 rhinological symptoms.
On a 10 centimeter scale, the patient will write the important of his symptoms, 10 being the maximum and 0 the minimum.
|
3 months
|
Side effects
Time Frame: 3 months
|
Compare side effects when using prophylactic antibiotics after endoscopic sinus surgery for chronic rhinosinusitis versus placebo.
|
3 months
|
Modified Lund-Kennedy endoscopic score
Time Frame: 6 months
|
The modified Lund-Kennedy score is an endoscopic score that measures sinus involvement during endoscopy.
It is divided into 2 nostrils.
For each nostril, it has a score of 0 to 2 for the presence of polyp, edema and flow.
The score is therefore 0 to 6 for each nostril for a maximum of 12.
The higher the score, the more severe is the condition
|
6 months
|
Quality of life of patients SNOT-22
Time Frame: 1 months
|
The SNOT-22 score is a quality of life score.
It contains 22 sinus symptoms.
Each of the symptoms is scored from 0 to 5, with 0 being no problem and 5 being a severe problem.
The SNOT-22 is a score of 0 to 110, the higher the score, the more severe the disease.
|
1 months
|
Quality of life of patients SNOT-22
Time Frame: 6 months
|
The SNOT-22 score is a quality of life score.
It contains 22 sinus symptoms.
Each of the symptoms is scored from 0 to 5, with 0 being no problem and 5 being a severe problem.
The SNOT-22 is a score of 0 to 110, the higher the score, the more severe the disease.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Paranasal Sinus Diseases
- Nose Diseases
- Sinusitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- beta-Lactamase Inhibitors
- Amoxicillin
- Clavulanic Acid
- Clavulanic Acids
Other Study ID Numbers
- ATBprophylacticCES
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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