Clinical trial NCT03014687: Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Antibiotics
Pituitary Adenoma
Keywords: transsphenoidal surgery
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
name: The Cleveland Clinic
First posted: 2017-01-09
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in quality of life from baseline - Anterior Skull Base Nasal Inventory 12 (ASK Nasal-12)
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
measure: Change in quality of life from baseline - Sino-Nasal Outcome Test (SNOT-22)
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Secondary outcomes:
measure: Incidence of Acute Bacterial Sinusitis
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
measure: Changes in endoscopic appearances using Postoperative Debridement Scoring Sheet (modified Lund-Kennedy score)
timeFrame: 1-2 and 3-4 weeks post-surgery
measure: Sinusitis and antibiotic resistance as evidenced by nasal congestion
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
measure: Sinusitis and antibiotic resistance as evidenced by purulent discharge
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
measure: Sinusitis and antibiotic resistance as evidenced by pressure
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
measure: Sinusitis and antibiotic resistance as evidenced by pain
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
measure: Sinusitis and antibiotic resistance as evidenced headache
timeFrame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Brain and Spine
state: Arizona
Study officials:
affiliation: Barrow Brain and Spine
name: Andrew Little, MD
role: STUDY_CHAIR
affiliation: Thomas Jefferson University
name: James Evans, MD
role: STUDY_CHAIR
References: