Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 84 |
| Updated: | 8/17/2018 |
| Start Date: | July 1, 2017 |
| End Date: | July 2019 |
| Contact: | Heidi Jahnke, RN, MSN |
| Email: | heidi.jahnke@dignityhealth.org |
| Phone: | 602-406-6976 |
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Impact of Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for
pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection
(sinusitis), and helps mucosal healing in the nasal passages.
pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection
(sinusitis), and helps mucosal healing in the nasal passages.
Transsphenoidal surgery is the standard of care for most symptomatic pituitary adenomas.
Since transsphenoidal surgery exploits the nasal passage to reach the sella turcica and
pituitary gland, the technique causes disruption of sinonasal function and temporarily
impacts sinonasal quality of life. Disrupted sinonasal function is a primary source of
postoperative morbidity following transsphenoidal surgery. Common sinonasal complications
include sinusitis, synechiae formation, nasal obstruction and crusting. The development of
postoperative sinusitis is specifically associated with decreased sinonasal function after
surgery. Because the nasal cavity is a contaminated surgical field, practitioners routinely
prescribe a course of oral postoperative antibiotics for 7-14 days (in addition to standard
prophylactic perioperative intravenous antibiotics) with the intention of improving nasal
functional outcomes. To date, no studies have examined whether the administration of oral
antibiotics following transsphenoidal surgery improves sinonasal healing. This question has
been studied in a closely-related field, functional endoscopic sinus surgery (FESS). A
meta-analysis of clinical trial data obtained in FESS indicated that current literature does
not support the use of oral antibiotics to reduce infection, improve symptoms scores, or
improve endoscopic findings. Furthermore, there is the potential for antibiotic-related
adverse events including the emergence of bacterial resistance, Clostridium difficile
infection, and allergic reactions to the medication. Despite the lack of supporting evidence
in FESS, prophylactic antibiotic use for improving sinonasal healing is still common in
pituitary surgery. The investigators propose to study whether prophylactic oral antibiotics
following transsphenoidal surgery improve sinonasal quality of life, reduce sinusitis
incidence, and promote mucosal healing following endoscopic transsphenoidal surgery.
Since transsphenoidal surgery exploits the nasal passage to reach the sella turcica and
pituitary gland, the technique causes disruption of sinonasal function and temporarily
impacts sinonasal quality of life. Disrupted sinonasal function is a primary source of
postoperative morbidity following transsphenoidal surgery. Common sinonasal complications
include sinusitis, synechiae formation, nasal obstruction and crusting. The development of
postoperative sinusitis is specifically associated with decreased sinonasal function after
surgery. Because the nasal cavity is a contaminated surgical field, practitioners routinely
prescribe a course of oral postoperative antibiotics for 7-14 days (in addition to standard
prophylactic perioperative intravenous antibiotics) with the intention of improving nasal
functional outcomes. To date, no studies have examined whether the administration of oral
antibiotics following transsphenoidal surgery improves sinonasal healing. This question has
been studied in a closely-related field, functional endoscopic sinus surgery (FESS). A
meta-analysis of clinical trial data obtained in FESS indicated that current literature does
not support the use of oral antibiotics to reduce infection, improve symptoms scores, or
improve endoscopic findings. Furthermore, there is the potential for antibiotic-related
adverse events including the emergence of bacterial resistance, Clostridium difficile
infection, and allergic reactions to the medication. Despite the lack of supporting evidence
in FESS, prophylactic antibiotic use for improving sinonasal healing is still common in
pituitary surgery. The investigators propose to study whether prophylactic oral antibiotics
following transsphenoidal surgery improve sinonasal quality of life, reduce sinusitis
incidence, and promote mucosal healing following endoscopic transsphenoidal surgery.
Inclusion Criteria:
- Adult patient undergoing endoscopic surgery for resection of pituitary tumors for
nonfunctioning adenoma, acromegaly, or prolactinoma
- Adults >18 and <85 years of age
- English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales
- Free of any physical, mental, or medical condition which, in the opinion of the
investigator, makes study participation inadvisable
Exclusion Criteria:
- Anaphylaxis/intolerance to the study drugs
- Cirrhosis, hepatitis
- Any solid organ transplant or bone marrow transplant. And any patient felt to be
immunocompromised by the investigators
- Renal failure on dialysis
- Any subject who is unwilling or unable to sign informed consent for the study
- Pregnancy
- Incarcerated patients
- Cushing's disease
- Rathke's Cleft cyst or pituitary cyst
- History of chronic sinusitis
- Anticipated use of nasal splints
- Anticipated use of nasal septal flap
- Active sinusitis
- Nasal polyps
- Previous sinus surgery
- Concurrent antibiotics for another indication (i.e., urinary tract infection)
- Immunodeficiency
We found this trial at
1
site
Phoenix, Arizona 85013
Principal Investigator: Andrew Little, MD
Phone: 602-406-6976
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