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The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp

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ClinicalTrials.gov Identifier: NCT03809312
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Simon-Pierre Harvey-Bolduc, CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date  ICMJE January 15, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date July 24, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • 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.
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.

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
Condition  ICMJE Chronic Sinus Infection
Intervention  ICMJE
  • Drug: Amoxicillin / Clavulanic acid 875mg / 125mg
    Amoxicillin / Clavulanic acid 875 mg / 125 mg BID x 10 days
  • Drug: Placebos
    Placebos BID x 10 days
Study Arms  ICMJE
  • 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
    Intervention: Drug: Amoxicillin / Clavulanic acid 875mg / 125mg
  • 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
    Intervention: Drug: Placebos
  • 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
    Intervention: Drug: Amoxicillin / Clavulanic acid 875mg / 125mg
  • 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
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2019)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP