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The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Sinus Infection | Drug: Amoxicillin / Clavulanic acid 875mg / 125mg Drug: Placebos | Phase 4 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 134 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 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 give either a prescription of Clavulin 875 mg per os to be taken twice a day for 10 days, or a placebo of similar visual appearance according to the same dosage |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Randomisation by the pharmacy, no one in the investigator and the participant will know the intervention |
| Primary Purpose: | Prevention |
| Official Title: | The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp: A Randomized, Double-blind Clinical Trial |
| Actual Study Start Date : | August 14, 2019 |
| Estimated Primary Completion Date : | December 2020 |
| Estimated Study Completion Date : | February 2021 |
| 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
|
Drug: Amoxicillin / Clavulanic acid 875mg / 125mg
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
|
Drug: Placebos
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
|
Drug: Amoxicillin / Clavulanic acid 875mg / 125mg
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
|
Drug: Placebos
Placebos BID x 10 days
|
- 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
- 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.
- 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
- 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.
- 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.
- Side effects [ Time Frame: 3 months ]Compare side effects when using prophylactic antibiotics after endoscopic sinus surgery for chronic rhinosinusitis versus placebo.
- 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
- 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.
- 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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Simon-Pierre Harvey-Bolduc, DR | 418-455-6167 | simon-pierre.harvey-bolduc.1@ulaval.ca | |
| Contact: Marie-Noëlle Corriveau | marie-noelle.corriveau@fmed.ulaval.ca |
| Canada | |
| Simon-Pierre Harvey-Bolduc | Recruiting |
| Québec, Canada, G1H0C2 | |
| Contact: Simon-Pierre Harvey-Bolduc, DR 418-455-6167 simon-pierre.harvey-bolduc.1@ulaval.ca | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | January 15, 2019 | ||||||||
| First Posted Date ICMJE | January 18, 2019 | ||||||||
| Last Update Posted Date | July 14, 2020 | ||||||||
| Actual Study Start Date ICMJE | August 14, 2019 | ||||||||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp | ||||||||
| Official Title ICMJE | The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp: A Randomized, Double-blind Clinical Trial | ||||||||
| Brief Summary | This is a randomized, double-blind clinical trial on the prophylactic use of antibiotics in postoperative endoscopic sinus vs placebo surgery. Patients with chronic rhinosinusitis with or without polyps who have consented to endoscopic sinus surgery according to Canadian practice guidelines may be included in the study after approval by the Research Ethics Board of the University Hospital Center. Quebec and signature of consent. | ||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 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 give either a prescription of Clavulin 875 mg per os to be taken twice a day for 10 days, or a placebo of similar visual appearance according to the same dosage Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Randomisation by the pharmacy, no one in the investigator and the participant will know the intervention Primary Purpose: Prevention
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| Condition ICMJE | Chronic Sinus Infection | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
134 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | February 2021 | ||||||||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03809312 | ||||||||
| Other Study ID Numbers ICMJE | ATBprophylacticCES | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Simon-Pierre Harvey-Bolduc, CHU de Quebec-Universite Laval | ||||||||
| Study Sponsor ICMJE | CHU de Quebec-Universite Laval | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | CHU de Quebec-Universite Laval | ||||||||
| Verification Date | July 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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