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Surgeons commonly prescribe post operative prophylactic antibiotics after sinus surgery. There is minimal data to support this. The investigators' study will aim to demonstrate that patients' quality of life and rate of post operative infection is the same whether they receive or do not receive antibiotics post operatively. The investigators hypothesis is that the disease specific quality of life of patients taking post-operative antibiotics is not inferior to the quality of life of patients who do not take post-operative antibiotics, and the rate of post-operative infections are the same. The investigators' specific aim is to compare validated symptom scores between post-operative populations who are given or are not given antibiotics. Rates of infections in the first 10 days after surgery will be recorded. The investigators will also compare endoscopic grades of sinus cavities during the post-operative follow up exams as an additional outcome measure.
Functional endoscopic sinus surgery (FESS) is a commonly performed procedure in the United States to treat chronic rhinosinusitis. Common practice is to prescribe prophylactic antibiotics postoperatively. This is similar to the long tradition of prophylactic antibiotics after tonsillectomy. The American Academy of Otolaryngology - Head and Neck Surgery recently strongly recommended against prophylactic antibiotics after tonsillectomy. In this light, this study would demonstrate the lack of need for antibiotics after FESS. Currently one surgeon does not prescribe antibiotics except when evidence of active infection was found during surgery. The other surgeon in the study currently prescribes antibiotics. This study would prospectively compare the two groups in a randomized fashion. The investigators' plan to use the Sinonasal outcomes test - 22 (SNOT-22) as the investigators' primary outcomes measure, which is a validated quality of life instrument in sinusitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amoxicillin-Potassium Clavulanate | Experimental | All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery. |
|
| Placebo | Placebo Comparator | All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin-Potassium Clavulanate | Drug | Patients in this arm will receive 500mg of Amoxicillin-Potassium Clavulanate Combination orally twice a day for 7 days after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sinonasal Outcome Test - 22 | The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis. Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms. | One week post operatively |
| Sinonasal Outcome Test - 22 | The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis. Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms. | Six weeks post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Lund Kennedy Endoscopic Score | The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting). Scores range from 0 to 20 with higher scores indicating greater sinus disease. | One week postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Post Operative Infection | The investigators will record the rate of post operative infections in the two groups. | One week postoperatively |
| Number of Participants With Post Operative Infection |
Inclusion Criteria:
- Patients eligible for surgery would be patients with chronic rhinosinusitis (defined by the AAOHNS 2007 consensus statement by Rosenfeld et al) and have been determined by their surgeons to have persistent symptoms after maximal medical therapy. Maximal medical therapy is defined as a course of broad spectrum or culture-directed antibiotics used in conjunction with a nasal steroid.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric H Holbrook, MD | MEEI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19793277 | Background | Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x. | |
| 17761281 | Background | Rosenfeld RM, Andes D, Bhattacharyya N, Cheung D, Eisenberg S, Ganiats TG, Gelzer A, Hamilos D, Haydon RC 3rd, Hudgins PA, Jones S, Krouse HJ, Lee LH, Mahoney MC, Marple BF, Mitchell CJ, Nathan R, Shiffman RN, Smith TL, Witsell DL. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg. 2007 Sep;137(3 Suppl):S1-31. doi: 10.1016/j.otohns.2007.06.726. |
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134 participants signed consent, but only 89 were randomized. The remainder failed screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amoxicillin-Potassium Clavulanate | All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery. |
| FG001 | Placebo | All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amoxicillin-Potassium Clavulanate | All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sinonasal Outcome Test - 22 | The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis. Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms. | Posted | Mean | Standard Deviation | score on a scale | One week post operatively |
|
Follow-ups at one week post-surgery and then 6 weeks post-surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amoxicillin-Potassium Clavulanate | All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Holbrook | Massachusetts Eye & Ear Infirmary | 617-573-3209 | Eric_Holbrook@meei.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2014 | Jan 28, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2020 | Feb 13, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
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|
| Placebo | Drug | Patients in this arm will receive 7 days of placebo after surgery. |
|
| Lund Kennedy Endoscopic Score | The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting). Scores range from 0 to 20 with higher scores indicating greater sinus disease. | Six weeks postoperatively |
The investigators will record the rate of post operative infections in the two groups.
| Six weeks postoperatively |
| 33340285 | Derived | Lehmann AE, Raquib AR, Siddiqi SH, Meier J, Durand ML, Gray ST, Holbrook EH. Prophylactic antibiotics after endoscopic sinus surgery for chronic rhinosinusitis: a randomized, double-blind, placebo-controlled noninferiority clinical trial. Int Forum Allergy Rhinol. 2021 Jul;11(7):1047-1055. doi: 10.1002/alr.22756. Epub 2020 Dec 19. |
| Protocol Violation |
|
All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lund Kennedy Endoscopic Score | The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scaring, and crusting). Scores range from 0 to 20 with higher scores indicating greater sinus disease. | Mean | Full Range | units on a scale |
|
| SNOT-22 Scores | The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis. Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms. | Mean | Full Range | units on a scale |
|
|
|
| Primary | Sinonasal Outcome Test - 22 | The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis. Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms. | Posted | Mean | Standard Deviation | score on a scale | Six weeks post operatively |
|
|
|
| Secondary | Lund Kennedy Endoscopic Score | The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting). Scores range from 0 to 20 with higher scores indicating greater sinus disease. | Posted | Mean | Standard Deviation | score on a scale | One week postoperatively |
|
|
|
| Secondary | Lund Kennedy Endoscopic Score | The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting). Scores range from 0 to 20 with higher scores indicating greater sinus disease. | Posted | Mean | Standard Deviation | score on a scale | Six weeks postoperatively |
|
|
|
| Other Pre-specified | Number of Participants With Post Operative Infection | The investigators will record the rate of post operative infections in the two groups. | Posted | Count of Participants | Participants | One week postoperatively |
|
|
|
| Other Pre-specified | Number of Participants With Post Operative Infection | The investigators will record the rate of post operative infections in the two groups. | Posted | Count of Participants | Participants | Six weeks postoperatively |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 10 |
| 43 |
| EG001 | Placebo | All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery. | 0 | 46 | 0 | 46 | 1 | 46 |
| Infection | Infections and infestations | Non-systematic Assessment |
|
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |