Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial
| Status: | Completed |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/5/2018 |
| Start Date: | February 2013 |
| End Date: | September 2018 |
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.
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.
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.
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
We found this trial at
1
site
243 Charles St
Boston, Massachusetts 02114
Boston, Massachusetts 02114
(617) 523-7900
Principal Investigator: Eric Holbrook, MD
Phone: 617-573-3209
Massachusetts Eye & Ear Infirmary Whether you see our physicians at Mass. Eye and Ear's...
Click here to add this to my saved trials
