Sinusitis
Conditions
Keywords
Chronic rhinosinusitis, Sinus surgery, Antibiotics
Brief summary
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.
Detailed description
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.
Interventions
Patients in this arm will receive 500mg of Amoxicillin-Potassium Clavulanate Combination orally twice a day for 7 days after surgery.
DRUGPlacebo
Patients in this arm will receive 7 days of placebo after surgery.
Sponsors
Massachusetts Eye and Ear Infirmary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
1. Penicillin, cephalosporin, amoxicillin/clavulanate allergy 2. Cystic Fibrosis 3. Immunodeficiency 4. Presence of any foreign body (ie.absorbable and non-absorbable packing) after surgery 5. Odontogenic causes of sinusitis 6. Fungal ball 7. Infected mucocele 8. Complication of sinusitis (meningitis, orbital complication, cellulitis, brain abscess) 9. Non endoscopic sinus surgery (Caldwell luc, external approaches, etc) 10. Age \<18 11. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sinonasal Outcome Test - 22 | One week post operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lund Kennedy Endoscopic Score | One week postoperatively | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post Operative Infection | One week postoperatively | The investigators will record the rate of post operative infections in the two groups. |
Countries
United States
Participant flow
Pre-assignment details
134 participants signed consent, but only 89 were randomized. The remainder failed screening.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| 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. | 41 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo | Amoxicillin-Potassium Clavulanate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 37 Participants | 77 Participants |
| Age, Continuous | 40.8 years | 46.5 years | 43.65 years |
| Lund Kennedy Endoscopic Score | 8.2 units on a scale | 8.2 units on a scale | 8.2 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 41 participants | 38 participants | 79 participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 28 Participants | 24 Participants | 52 Participants |
| SNOT-22 Scores | 39.0 units on a scale | 47.8 units on a scale | 43.4 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 46 |
| other Total, other adverse events | 10 / 43 | 1 / 46 |
| serious Total, serious adverse events | 0 / 43 | 0 / 46 |
Outcome results
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.
Time frame: One week post operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amoxicillin-Potassium Clavulanate | Sinonasal Outcome Test - 22 | 31.3 score on a scale | Standard Deviation 21.7 |
| Placebo | Sinonasal Outcome Test - 22 | 31.0 score on a scale | Standard Deviation 19.4 |
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.
Time frame: Six weeks post operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amoxicillin-Potassium Clavulanate | Sinonasal Outcome Test - 22 | 22.3 score on a scale | Standard Deviation 21.5 |
| Placebo | Sinonasal Outcome Test - 22 | 17.5 score on a scale | Standard Deviation 15.3 |
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.
Time frame: Six weeks postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amoxicillin-Potassium Clavulanate | Lund Kennedy Endoscopic Score | 4.3 score on a scale | Standard Deviation 2.6 |
| Placebo | Lund Kennedy Endoscopic Score | 4.5 score on a scale | Standard Deviation 2.8 |
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.
Time frame: One week postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amoxicillin-Potassium Clavulanate | Lund Kennedy Endoscopic Score | 5.6 score on a scale | Standard Deviation 1.8 |
| Placebo | Lund Kennedy Endoscopic Score | 5.9 score on a scale | Standard Deviation 2.9 |
Other Pre-specified
Number of Participants With Post Operative Infection
The investigators will record the rate of post operative infections in the two groups.
Time frame: One week postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Amoxicillin-Potassium Clavulanate | Number of Participants With Post Operative Infection | 1 Participants |
| Placebo | Number of Participants With Post Operative Infection | 0 Participants |
Other Pre-specified
Number of Participants With Post Operative Infection
The investigators will record the rate of post operative infections in the two groups.
Time frame: Six weeks postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Amoxicillin-Potassium Clavulanate | Number of Participants With Post Operative Infection | 0 Participants |
| Placebo | Number of Participants With Post Operative Infection | 0 Participants |