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Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions (POET)

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ClinicalTrials.gov Identifier: NCT03014687
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : August 15, 2018
Sponsor:
Collaborators:
Thomas Jefferson University
The Cleveland Clinic
Information provided by (Responsible Party):
Pam Dewey, St. Joseph's Hospital and Medical Center, Phoenix

Tracking Information
First Submitted Date  ICMJE January 4, 2017
First Posted Date  ICMJE January 9, 2017
Last Update Posted Date August 15, 2018
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
  • Change in quality of life from baseline - Anterior Skull Base Nasal Inventory 12 (ASK Nasal-12) [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery ]
    Completed by subject in clinic or by phone interview. Assesses urge to blow nose; post-nasal discharge; thick nasal discharge; headaches; nose makes whistling sound; nasal crusting; trouble breathing through nose during day; trouble breathing through nose during night; not breathing equally in both nostrils; sense of smell; sense of taste; and, overall functioning of nose.Rating choices include no problem 0; very minor problem 1; minor problem 2; moderate problem 3; moderately severe problem 4; and, severe problem 5. Subject also selects the 5 symptoms/items listed that impact life the most.
  • Change in quality of life from baseline - Sino-Nasal Outcome Test (SNOT-22) [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery ]
    Completed by subject in clinic or by phone interview. Assesses need to blow nose; nasal blockage; sneezing; runny nose; cough; post-nasal discharge; thick nasal discharge; ear fullness; dizziness; ear pain; facial pain/pressure; decreased sense of smell/taste; difficulty falling asleep; waking up at night; lack of a good night's sleep; wake up tired; fatigue; reduced productivity; reduced concentration; frustrated/restless/irritable; sad; and, embarrassed. Rating choices include no problem 0; very mild problem 1; mild or slight problem 2; moderate problem 3; severe problem 4; problem as bad as it can be 5. Subject also selects the 5 symptoms/items listed that impact life the most.
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
  • Change in quality of life from baseline - Anterior Skull Base Nasal Inventory 12 (ASK Nasal-12) [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery ]
    Completed by subject in clinic or by phone interview. Assesses urge to blow nose; post-nasal discharge; thick nasal discharge; headaches; nose makes whistling sound; nasal crusting; trouble breathing through nose during day; trouble breathing through nose during night; not breathing equally in both nostrils; sense of smell; sense of taste; and, overall functioning of nose.Rating choices include no problem 0; very minor problem 1; minor problem 2; moderate problem 3; moderately severe problem 4; and, severe problem 5. Subject also selects the 5 symptoms/items listed that impact life the most. Sinonasal quality of life as estimated by patient-reported Anterior Skull Base Nasal Inventory 12 (ASK Nasal-12) and Sino-Nasal Outcomes Test 22 (SNOT-22) rhinologic domain scores, and compared to scores obtained at preoperative baseline. ASK Nasal-12 and SNOT-22 scoring can be completed during a clinic visit or by phone interview.
  • Change in quality of life from baseline - Sino-Nasal Outcome Test (SNOT-22) [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery ]
    Completed by subject in clinic or by phone interview. Assesses need to blow nose; nasal blockage; sneezing; runny nose; cough; post-nasal discharge; thick nasal discharge; ear fullness; dizziness; ear pain; facial pain/pressure; decreased sense of smell/taste; difficulty falling asleep; waking up at night; lack of a good night's sleep; wake up tired; fatigue; reduced productivity; reduced concentration; frustrated/restless/irritable; sad; and, embarrassed. Rating choices include no problem 0; very mild problem 1; mild or slight problem 2; moderate problem 3; severe problem 4; problem as bad as it can be 5. Subject also selects the 5 symptoms/items listed that impact life the most.
Change History Complete list of historical versions of study NCT03014687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
  • Incidence of Acute Bacterial Sinusitis [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery ]
    Incidence includes 3 or more of: i. Nasal congestion by patient report or physical exam, ii. Purulent nasal discharge by patient report or physical exam, iii. Facial pressure or pain or headache by patient report, iv. Antibiotics prescribed by a provider for the purpose of treating sinusitis.
  • Changes in endoscopic appearances using Postoperative Debridement Scoring Sheet (modified Lund-Kennedy score) [ Time Frame: 1-2 and 3-4 weeks post-surgery ]
    Postoperative nasal endoscopy findings graded by surgeon. Grading includes Polyps = none 0; middle meatus 1; beyond middle meatus 2. Discharge = none 0; clear and thin 1; thick and purulent 2. Edema = none 0; mild 1; moderate 2; severe 3. Scarring = none 0; mild 1; moderate 2; severe 3. Crusting = none 0; mild 1; moderate 2; severe 3.
  • Sinusitis and antibiotic resistance as evidenced by nasal congestion [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery ]
    Cultures and sensitivities when nasal congestion noted by patient report or physical exam.
  • Sinusitis and antibiotic resistance as evidenced by purulent discharge [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery ]
    Cultures and sensitivities when purulent nasal discharge noted by patient report or physical exam.
  • Sinusitis and antibiotic resistance as evidenced by pressure [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery ]
    Cultures and sensitivities when facial pressure noted by patient report.
  • Sinusitis and antibiotic resistance as evidenced by pain [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery ]
    Cultures and sensitivities when facial pain noted by patient report.
  • Sinusitis and antibiotic resistance as evidenced headache [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery ]
    Cultures and sensitivities when headache noted by patient report.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Antibiotics
  • Pituitary Adenoma
Intervention  ICMJE
  • Drug: Placebo
    PO BID placebo for 7 days. Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.
    Other Name: inert substance
  • Drug: Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole
    Oral antibiotics (cefdinir [Omnicef®] 300 mg PO BID or trimethoprim/sulfamethoxazole [Bactrim DS™] PO BID for cephalosporin intolerant patients) for 7 days.Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.
    Other Names:
    • Omnicef
    • Bactrim DS™ cephalosporin intolerant patients
Study Arms  ICMJE
  • Placebo Comparator: Standard Nasal Care
    One dose of preoperative intravenous (iv) antibiotic (e.g., cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg will be administered within 60 minutes of start of surgery. Repeat intraoperative dosing of antibiotics is permitted if length of surgery exceeds recommended dosing interval. IV antibiotic dosing schedules: Cefazolin 1 gm iv Q6 hr -or- Cefuroxime 1.5gm iv Q8 hr -or- Clindamycin 300 mg iv Q12 hr. Postoperative antibiotics: Study participants will receive one dose only of postoperative intravenous antibiotic (e.g., cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg [cephalosporin allergic patients]) according to the recommended dosing schedule described above. This dose of antibiotics is in addition to the preoperative dose. Placebo PO BID (twice daily) will commence on the morning of postoperative day 1 and continue for 7 days.
    Intervention: Drug: Placebo
  • Experimental: Standard Nasal Care + Oral Antibiotics
    One dose of preoperative iv antibiotic (cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg) will be administered within 60 minutes of start of surgery. Repeat intraoperative dosing of antibiotics is permitted if length of surgery exceeds recommended dosing interval. IV antibiotic dosing schedules: Cefazolin 1 gm iv Q6 hr -or- Cefuroxime 1.5gm iv Q8 hr -or- Clindamycin 300 mg iv Q12 hr. Participants will receive 1 dose only of postoperative iv antibiotic (cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg [cephalosporin allergic patients]) according to the recommended dosing schedule described above. This dose of antibiotics is in addition to the preoperative dose. Oral antibiotics will commence on the morning of postoperative day 1; this group will receive oral antibiotics (cefdinir [Omnicef®] 300 mg PO BID or trimethoprim/sulfamethoxazole [Bactrim DS™] PO BID for cephalosporin intolerant patients) for 7 days.
    Intervention: Drug: Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2017)
116
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heidi Jahnke, RN, MSN 602-406-6976 heidi.jahnke@dignityhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03014687
Other Study ID Numbers  ICMJE PHX-16-0134-30-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Pam Dewey, St. Joseph's Hospital and Medical Center, Phoenix
Study Sponsor  ICMJE St. Joseph's Hospital and Medical Center, Phoenix
Collaborators  ICMJE
  • Thomas Jefferson University
  • The Cleveland Clinic
Investigators  ICMJE
Study Chair: Andrew Little, MD Barrow Brain and Spine
Study Chair: James Evans, MD Thomas Jefferson University
PRS Account St. Joseph's Hospital and Medical Center, Phoenix
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP