<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01689064</url>
  </required_header>
  <id_info>
    <org_study_id>E-24588</org_study_id>
    <nct_id>NCT01689064</nct_id>
  </id_info>
  <brief_title>Comparison of Surgical Approach to Endoscopic Pituitary Adenoma Resection</brief_title>
  <official_title>Comparison of the Posterior Septectomy and Stamm Approach to Endoscopic Pituitary Adenoma Resection: A Randomized, Single-blind Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if there is a significant difference in sinonasal&#xD;
      disease specific quality of life and utility scores between patients undergoing the posterior&#xD;
      septectomy or Stamm approach during endoscopic pituitary adenoma resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pituitary adenoma's represent 10 to 25% of all central nervous system (CNS) neoplasms and&#xD;
      have an estimated population prevalence of 94 per 100,000. Asymptomatic adenomas go largely&#xD;
      undetected since there is no screening protocol implemented with the purpose for early&#xD;
      identification. Asymptomatic adenomas can be detected incidentally on CNS imaging for other&#xD;
      indications in approximately 10% of studies and rarely require surgical intervention. In&#xD;
      2011, the Endocrine Society published practice guidelines on the management of pituitary&#xD;
      incidentalomas and provided the surgical indications. Incidental microadenoma's (&lt; 10 mm)&#xD;
      rarely need surgical intervention, however, incidental macroadenoma's (&gt; 10 mm) often&#xD;
      required surgical resection due to the proximity of the optic nerves and chiasm.&#xD;
&#xD;
      Most symptomatic pituitary adenomas require transnasal transsphenoid surgical resection. Due&#xD;
      to the potential for hormone secretion and location to vital structures such as the optic&#xD;
      chiasm/nerves, carotid artery, and cavernous sinus, management of symptomatic pituitary&#xD;
      adenomas often require a multi-disciplinary team involving neurosurgery, otolaryngology,&#xD;
      neuroophthalmology, and endocrinology. Traditionally the microscope was used for&#xD;
      visualization during pituitary tumor surgery, however with recent technologic advances, the&#xD;
      endoscopic approach has largely replaced the microscopic approach. A recent systematic review&#xD;
      and meta-analysis compared the microscopic and endoscopic approaches and have demonstrated&#xD;
      that the endoscopic approach results in a significant reduction in the rate of cerebral&#xD;
      spinal fluid (CSF) leak, improved tumor resection, improved patient comfort, and reduced&#xD;
      hospital length of stay. Furthermore, the endoscopic approach appears to provide an overall&#xD;
      cost savings compared to the microscopic approach.&#xD;
&#xD;
      Several recent studies have demonstrated that the endoscopic approach for pituitary adenoma&#xD;
      resection results in improved disease-specific quality of life (QoL) and general QoL. All&#xD;
      studies have utilized the posterior septectomy approach which involves removing the posterior&#xD;
      nasal septum to create a common posterior nasal cavity. The open posterior nasal cavity&#xD;
      provides excellent surgical access to the sphenoid sinus and pituitary gland. Disadvantages&#xD;
      of the posterior septectomy approach include the permanent posterior septal perforation which&#xD;
      may predispose to postoperative crusting and epistaxis. A recent article by Stamm et al.&#xD;
      described a novel endoscopic approach whereby the posterior septal mucosa is preserved while&#xD;
      still providing excellent access to the sphenoid. The primary advantage of this approach is&#xD;
      preventing a posterior septal defect, however disadvantages include being a more challenging&#xD;
      technique and the potential for reduced surgical visualization. Furthermore, there is still a&#xD;
      risk of a septal perforation due to intraoperative trauma and significant postoperative&#xD;
      crusting which often develops along the surface of the healing septal mucosa. Both endoscopic&#xD;
      approaches have inherent advantages and disadvantages and there has been no study comparing&#xD;
      these approaches. Surgeons performing endoscopic pituitary tumor resections utilize both&#xD;
      approaches and neither is considered the standard of care.&#xD;
&#xD;
      The purpose of this randomized, single-blinded study is to determine the clinical outcomes&#xD;
      between the posterior septectomy and Stamm approach for endoscopic pituitary adenoma&#xD;
      resection. We hypothesize that there will be no difference in disease-specific QoL and&#xD;
      general QoL between the two surgical approaches.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)</time_frame>
    <description>To determine the change in quality of life scores between the two groups at 2 weeks, 6 weeks, 3 months and 6 months using the anterior skull base nasal inventory questionnaire, the SinoNasal outcome test-22 questionnaire and the EQ-5D questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Score</measure>
    <time_frame>Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)</time_frame>
    <description>To determine the change in symptom score between the two groups at 2 weeks, 6 weeks, 3 months and 6 months using the VAS Nasal Symptom score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Utility Score</measure>
    <time_frame>Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)</time_frame>
    <description>To determine the change in utility score between the two groups at 2 weeks, 6 weeks, 3 months and 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Endoscopic Sinus Score</measure>
    <time_frame>Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)</time_frame>
    <description>To determine the change in endoscopic sinus score between the two groups at 2 weeks, 6 weeks, 3 months and 6 months using the endoscopic grading - Using both the Lund-Kennedy and POSE endoscopic scoring system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Olfaction</measure>
    <time_frame>Pre-operative and Post-operative (6 months)</time_frame>
    <description>To determine the change in olfaction between the two groups at 6 months using the Smell Identification Test (SIT).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Pituitary Adenoma</condition>
  <condition>Posterior Septectomy</condition>
  <condition>Stamm Approach</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Posterior Septectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will be randomized to a study arm. The patient will be blinded to the approach. The surgeon will have performed at least 10 procedures previous for each approach. The surgeon will maintain the following surgical practives: preservation of both middle turbinates, preservation of one superior turbinate (to minimize olfactory injury), elevation of a nasoseptal flap, the use of a combination of gelform, surgicel and nasapore dissolvable spacer placed within the surgical defect. These practices are all standard of care. Patient will start Neilmed high volume low pressure saline irrigation three times daily starting on post operative day five. Patients will receive prophylactic antibiotics for fourteen days post operatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stamm Approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will be randomized a study arm. The patient will be blinded to the approach. The surgeon will have performed at least 10 procedures previous for each approach. The surgeon will maintain the following surgical practives: preservation of both middle turbinates, preservation of one superior turbinate (to minimize olfactory injury), elevation of a nasoseptal flap, the use of a combination of gelform, surgicel and nasapore dissolvable spacer placed within the surgical defect. These practices are all standard of care. Patient will start Neilmed high volume low pressure saline irrigation three times daily starting on post operative day five. Patients will receive prophylactic antibiotics for fourteen days post operatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stamm Approach</intervention_name>
    <arm_group_label>Stamm Approach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Posterior Septectomy</intervention_name>
    <arm_group_label>Posterior Septectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Diagnosis of a pituitary adenoma requiring resection defined as pituitary lesion with&#xD;
             any of the following:&#xD;
&#xD;
               1. Neuroimaging or clinical evidence of apoplexy&#xD;
&#xD;
               2. Decline in central visual acuity worse than (best-corrected) Snellen equivalent&#xD;
                  of 20/25 in either eye&#xD;
&#xD;
               3. clinically significant visual field loss as determined by Humphrey or Goldmann&#xD;
                  perimetry&#xD;
&#xD;
               4. Clinically significant cranial nerve deficit&#xD;
&#xD;
               5. Clinically relevant neuroendocrine deficit&#xD;
&#xD;
               6. Intolerance of optimal medical management&#xD;
&#xD;
          -  Patient electing endoscopic resection approach&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent chronic rhinosinusitis&#xD;
&#xD;
          -  Revision pituitary adenoma resections&#xD;
&#xD;
          -  Severe medical co-morbidities with the inability to undergo general anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luke Rudmik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Daly AF, Rixhon M, Adam C, Dempegioti A, Tichomirowa MA, Beckers A. High prevalence of pituitary adenomas: a cross-sectional study in the province of Liege, Belgium. J Clin Endocrinol Metab. 2006 Dec;91(12):4769-75. doi: 10.1210/jc.2006-1668. Epub 2006 Sep 12.</citation>
    <PMID>16968795</PMID>
  </reference>
  <reference>
    <citation>Hall WA, Luciano MG, Doppman JL, Patronas NJ, Oldfield EH. Pituitary magnetic resonance imaging in normal human volunteers: occult adenomas in the general population. Ann Intern Med. 1994 May 15;120(10):817-20. doi: 10.7326/0003-4819-120-10-199405150-00001.</citation>
    <PMID>8154641</PMID>
  </reference>
  <reference>
    <citation>Freda PU, Beckers AM, Katznelson L, Molitch ME, Montori VM, Post KD, Vance ML; Endocrine Society. Pituitary incidentaloma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2011 Apr;96(4):894-904. doi: 10.1210/jc.2010-1048.</citation>
    <PMID>21474686</PMID>
  </reference>
  <reference>
    <citation>Rotenberg B, Tam S, Ryu WH, Duggal N. Microscopic versus endoscopic pituitary surgery: a systematic review. Laryngoscope. 2010 Jul;120(7):1292-7. doi: 10.1002/lary.20949.</citation>
    <PMID>20578228</PMID>
  </reference>
  <reference>
    <citation>DeKlotz TR, Chia SH, Lu W, Makambi KH, Aulisi E, Deeb Z. Meta-analysis of endoscopic versus sublabial pituitary surgery. Laryngoscope. 2012 Mar;122(3):511-8. doi: 10.1002/lary.22479. Epub 2012 Jan 17.</citation>
    <PMID>22252670</PMID>
  </reference>
  <reference>
    <citation>Oosmanally N, Paul JE, Zanation AM, Ewend MG, Senior BA, Ebert CS Jr. Comparative analysis of cost of endoscopic endonasal minimally invasive and sublabial-transseptal approaches to the pituitary. Int Forum Allergy Rhinol. 2011 Jul-Aug;1(4):242-9. doi: 10.1002/alr.20048. Epub 2011 Apr 28.</citation>
    <PMID>22287427</PMID>
  </reference>
  <reference>
    <citation>Graham SM, Iseli TA, Karnell LH, Clinger JD, Hitchon PW, Greenlee JD. Endoscopic approach for pituitary surgery improves rhinologic outcomes. Ann Otol Rhinol Laryngol. 2009 Sep;118(9):630-5. doi: 10.1177/000348940911800905.</citation>
    <PMID>19810602</PMID>
  </reference>
  <reference>
    <citation>Suberman TA, Zanation AM, Ewend MG, Senior BA, Ebert CS Jr. Sinonasal quality-of-life before and after endoscopic, endonasal, minimally invasive pituitary surgery. Int Forum Allergy Rhinol. 2011 May-Jun;1(3):161-6. doi: 10.1002/alr.20029. Epub 2011 Apr 26.</citation>
    <PMID>22287366</PMID>
  </reference>
  <reference>
    <citation>Stamm AC, Pignatari S, Vellutini E, Harvey RJ, Nogueira JF Jr. A novel approach allowing binostril work to the sphenoid sinus. Otolaryngol Head Neck Surg. 2008 Apr;138(4):531-2. doi: 10.1016/j.otohns.2007.11.031. No abstract available.</citation>
    <PMID>18359368</PMID>
  </reference>
  <reference>
    <citation>Little AS, Jahnke H, Nakaji P, Milligan J, Chapple K, White WL. The anterior skull base nasal inventory (ASK nasal inventory): a clinical tool for evaluating rhinological outcomes after endonasal surgery for pituitary and cranial base lesions. Pituitary. 2012 Dec;15(4):513-7. doi: 10.1007/s11102-011-0358-4.</citation>
    <PMID>22038032</PMID>
  </reference>
  <reference>
    <citation>Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.</citation>
    <PMID>19793277</PMID>
  </reference>
  <reference>
    <citation>Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.</citation>
    <PMID>8628042</PMID>
  </reference>
  <reference>
    <citation>Wright ED, Agrawal S. Impact of perioperative systemic steroids on surgical outcomes in patients with chronic rhinosinusitis with polyposis: evaluation with the novel Perioperative Sinus Endoscopy (POSE) scoring system. Laryngoscope. 2007 Nov;117(11 Pt 2 Suppl 115):1-28. doi: 10.1097/MLG.0b013e31814842f8.</citation>
    <PMID>18075447</PMID>
  </reference>
  <reference>
    <citation>Doty RL, Shaman P, Dann M. Development of the University of Pennsylvania Smell Identification Test: a standardized microencapsulated test of olfactory function. Physiol Behav. 1984 Mar;32(3):489-502. doi: 10.1016/0031-9384(84)90269-5.</citation>
    <PMID>6463130</PMID>
  </reference>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>December 1, 2014</last_update_submitted>
  <last_update_submitted_qc>December 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Dr. Luke Rudmik</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Pituitary Neoplasms</mesh_term>
    <mesh_term>Pituitary Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01689064
org study id: E-24588
nct id: NCT01689064
lead sponsor: 
has dmc: No
The purpose of this study is to determine if there is a significant difference in sinonasal
      disease specific quality of life and utility scores between patients undergoing the posterior
      septectomy or Stamm approach during endoscopic pituitary adenoma resection.
Pituitary adenoma's represent 10 to 25% of all central nervous system (CNS) neoplasms and
      have an estimated population prevalence of 94 per 100,000. Asymptomatic adenomas go largely
      undetected since there is no screening protocol implemented with the purpose for early
      identification. Asymptomatic adenomas can be detected incidentally on CNS imaging for other
      indications in approximately 10% of studies and rarely require surgical intervention. In
      2011, the Endocrine Society published practice guidelines on the management of pituitary
      incidentalomas and provided the surgical indications. Incidental microadenoma's (< 10 mm)
      rarely need surgical intervention, however, incidental macroadenoma's (> 10 mm) often
      required surgical resection due to the proximity of the optic nerves and chiasm.

      Most symptomatic pituitary adenomas require transnasal transsphenoid surgical resection. Due
      to the potential for hormone secretion and location to vital structures such as the optic
      chiasm/nerves, carotid artery, and cavernous sinus, management of symptomatic pituitary
      adenomas often require a multi-disciplinary team involving neurosurgery, otolaryngology,
      neuroophthalmology, and endocrinology. Traditionally the microscope was used for
      visualization during pituitary tumor surgery, however with recent technologic advances, the
      endoscopic approach has largely replaced the microscopic approach. A recent systematic review
      and meta-analysis compared the microscopic and endoscopic approaches and have demonstrated
      that the endoscopic approach results in a significant reduction in the rate of cerebral
      spinal fluid (CSF) leak, improved tumor resection, improved patient comfort, and reduced
      hospital length of stay. Furthermore, the endoscopic approach appears to provide an overall
      cost savings compared to the microscopic approach.

      Several recent studies have demonstrated that the endoscopic approach for pituitary adenoma
      resection results in improved disease-specific quality of life (QoL) and general QoL. All
      studies have utilized the posterior septectomy approach which involves removing the posterior
      nasal septum to create a common posterior nasal cavity. The open posterior nasal cavity
      provides excellent surgical access to the sphenoid sinus and pituitary gland. Disadvantages
      of the posterior septectomy approach include the permanent posterior septal perforation which
      may predispose to postoperative crusting and epistaxis. A recent article by Stamm et al.
      described a novel endoscopic approach whereby the posterior septal mucosa is preserved while
      still providing excellent access to the sphenoid. The primary advantage of this approach is
      preventing a posterior septal defect, however disadvantages include being a more challenging
      technique and the potential for reduced surgical visualization. Furthermore, there is still a
      risk of a septal perforation due to intraoperative trauma and significant postoperative
      crusting which often develops along the surface of the healing septal mucosa. Both endoscopic
      approaches have inherent advantages and disadvantages and there has been no study comparing
      these approaches. Surgeons performing endoscopic pituitary tumor resections utilize both
      approaches and neither is considered the standard of care.

      The purpose of this randomized, single-blinded study is to determine the clinical outcomes
      between the posterior septectomy and Stamm approach for endoscopic pituitary adenoma
      resection. We hypothesize that there will be no difference in disease-specific QoL and
      general QoL between the two surgical approaches.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Quality of Life
time frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
description: To determine the change in quality of life scores between the two groups at 2 weeks, 6 weeks, 3 months and 6 months using the anterior skull base nasal inventory questionnaire, the SinoNasal outcome test-22 questionnaire and the EQ-5D questionnaire.
measure: Change in Symptom Score
time frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
description: To determine the change in symptom score between the two groups at 2 weeks, 6 weeks, 3 months and 6 months using the VAS Nasal Symptom score.
measure: Change in Utility Score
time frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
description: To determine the change in utility score between the two groups at 2 weeks, 6 weeks, 3 months and 6 months.
measure: Change in Endoscopic Sinus Score
time frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
description: To determine the change in endoscopic sinus score between the two groups at 2 weeks, 6 weeks, 3 months and 6 months using the endoscopic grading - Using both the Lund-Kennedy and POSE endoscopic scoring system.
measure: Change in Olfaction
time frame: Pre-operative and Post-operative (6 months)
description: To determine the change in olfaction between the two groups at 6 months using the Smell Identification Test (SIT).
arm group label: Posterior Septectomy
arm group type: Active Comparator
description: Patient will be randomized to a study arm. The patient will be blinded to the approach. The surgeon will have performed at least 10 procedures previous for each approach. The surgeon will maintain the following surgical practives: preservation of both middle turbinates, preservation of one superior turbinate (to minimize olfactory injury), elevation of a nasoseptal flap, the use of a combination of gelform, surgicel and nasapore dissolvable spacer placed within the surgical defect. These practices are all standard of care. Patient will start Neilmed high volume low pressure saline irrigation three times daily starting on post operative day five. Patients will receive prophylactic antibiotics for fourteen days post operatively.
arm group label: Stamm Approach
arm group type: Experimental
description: Patient will be randomized a study arm. The patient will be blinded to the approach. The surgeon will have performed at least 10 procedures previous for each approach. The surgeon will maintain the following surgical practives: preservation of both middle turbinates, preservation of one superior turbinate (to minimize olfactory injury), elevation of a nasoseptal flap, the use of a combination of gelform, surgicel and nasapore dissolvable spacer placed within the surgical defect. These practices are all standard of care. Patient will start Neilmed high volume low pressure saline irrigation three times daily starting on post operative day five. Patients will receive prophylactic antibiotics for fourteen days post operatively.
intervention type: Procedure
intervention name: Stamm Approach
arm group label: Stamm Approach
intervention type: Procedure
intervention name: Posterior Septectomy
arm group label: Posterior Septectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luke Rudmik, MD
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
citation: Daly AF, Rixhon M, Adam C, Dempegioti A, Tichomirowa MA, Beckers A. High prevalence of pituitary adenomas: a cross-sectional study in the province of Liege, Belgium. J Clin Endocrinol Metab. 2006 Dec;91(12):4769-75. doi: 10.1210/jc.2006-1668. Epub 2006 Sep 12.
PMID: 16968795
citation: Hall WA, Luciano MG, Doppman JL, Patronas NJ, Oldfield EH. Pituitary magnetic resonance imaging in normal human volunteers: occult adenomas in the general population. Ann Intern Med. 1994 May 15;120(10):817-20. doi: 10.7326/0003-4819-120-10-199405150-00001.
PMID: 8154641
citation: Freda PU, Beckers AM, Katznelson L, Molitch ME, Montori VM, Post KD, Vance ML; Endocrine Society. Pituitary incidentaloma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2011 Apr;96(4):894-904. doi: 10.1210/jc.2010-1048.
PMID: 21474686
citation: Rotenberg B, Tam S, Ryu WH, Duggal N. Microscopic versus endoscopic pituitary surgery: a systematic review. Laryngoscope. 2010 Jul;120(7):1292-7. doi: 10.1002/lary.20949.
PMID: 20578228
citation: DeKlotz TR, Chia SH, Lu W, Makambi KH, Aulisi E, Deeb Z. Meta-analysis of endoscopic versus sublabial pituitary surgery. Laryngoscope. 2012 Mar;122(3):511-8. doi: 10.1002/lary.22479. Epub 2012 Jan 17.
PMID: 22252670
citation: Oosmanally N, Paul JE, Zanation AM, Ewend MG, Senior BA, Ebert CS Jr. Comparative analysis of cost of endoscopic endonasal minimally invasive and sublabial-transseptal approaches to the pituitary. Int Forum Allergy Rhinol. 2011 Jul-Aug;1(4):242-9. doi: 10.1002/alr.20048. Epub 2011 Apr 28.
PMID: 22287427
citation: Graham SM, Iseli TA, Karnell LH, Clinger JD, Hitchon PW, Greenlee JD. Endoscopic approach for pituitary surgery improves rhinologic outcomes. Ann Otol Rhinol Laryngol. 2009 Sep;118(9):630-5. doi: 10.1177/000348940911800905.
PMID: 19810602
citation: Suberman TA, Zanation AM, Ewend MG, Senior BA, Ebert CS Jr. Sinonasal quality-of-life before and after endoscopic, endonasal, minimally invasive pituitary surgery. Int Forum Allergy Rhinol. 2011 May-Jun;1(3):161-6. doi: 10.1002/alr.20029. Epub 2011 Apr 26.
PMID: 22287366
citation: Stamm AC, Pignatari S, Vellutini E, Harvey RJ, Nogueira JF Jr. A novel approach allowing binostril work to the sphenoid sinus. Otolaryngol Head Neck Surg. 2008 Apr;138(4):531-2. doi: 10.1016/j.otohns.2007.11.031. No abstract available.
PMID: 18359368
citation: Little AS, Jahnke H, Nakaji P, Milligan J, Chapple K, White WL. The anterior skull base nasal inventory (ASK nasal inventory): a clinical tool for evaluating rhinological outcomes after endonasal surgery for pituitary and cranial base lesions. Pituitary. 2012 Dec;15(4):513-7. doi: 10.1007/s11102-011-0358-4.
PMID: 22038032
citation: Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.
PMID: 19793277
citation: Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PMID: 8628042
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responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Dr. Luke Rudmik
investigator title: Principal Investigator
mesh term: Adenoma
mesh term: Pituitary Neoplasms
mesh term: Pituitary Diseases