Pituitary AdenomaNCT01689064
Comparison of Surgical Approach to Endoscopic Pituitary Adenoma Resection
A study testing Stamm Approach and Posterior Septectomy in people with Pituitary Adenoma and Posterior Septectomy, run by University of Calgary at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Adenoma, Posterior Septectomy, Stamm Approach
- What is being tested?
- Stamm Approach and Posterior Septectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Diagnosis of a pituitary adenoma requiring resection defined as pituitary lesion with any of the following:
- Neuroimaging or clinical evidence of apoplexy
- Decline in central visual acuity worse than (best-corrected) Snellen equivalent of 20/25 in either eye
- clinically significant visual field loss as determined by Humphrey or Goldmann perimetry
- Clinically significant cranial nerve deficit
Show all 9Show fewer
- Clinically relevant neuroendocrine deficit
- Intolerance of optimal medical management
- Patient electing endoscopic resection approach
Who cannot join
- Concurrent chronic rhinosinusitis
- Revision pituitary adenoma resections
- Severe medical co-morbidities with the inability to undergo general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Posterior Septectomy and Stamm Approach to Endoscopic Pituitary Adenoma Resection: A Randomized, Single-blind Trial
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.
Read the detailed description
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.
- Being tested
- Stamm Approach, Posterior Septectomy
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stamm ApproachProcedure or surgery
Posterior SeptectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Posterior Septectomy | Active comparator | 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. Receives: Procedure: Posterior Septectomy |
| Stamm Approach | Experimental | 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. Receives: Procedure: Stamm Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
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.
Measured: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
Secondary outcomes (4)
Change in Symptom Score
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.
Measured: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
Change in Utility Score
To determine the change in utility score between the two groups at 2 weeks, 6 weeks, 3 months and 6 months.
Measured: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
Change in Endoscopic Sinus Score
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.
Measured: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
Change in Olfaction
To determine the change in olfaction between the two groups at 6 months using the Smell Identification Test (SIT).
Measured: Pre-operative and Post-operative (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Luke Rudmik, University of Calgary
- Investigators
- Luke Rudmik, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689064
- Sponsor's protocol ID
- E-24588
- Status last verified
- Dec 2014
- First submitted
- 17 Sep 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16968795Hall 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.
PubMed 8154641Freda 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.
PubMed 21474686Rotenberg 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.
PubMed 20578228DeKlotz 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.
PubMed 22252670Oosmanally 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.
PubMed 22287427Graham 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.
PubMed 19810602Suberman 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.
PubMed 22287366Stamm 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.
PubMed 18359368Little 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.
PubMed 22038032Hopkins 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.
PubMed 19793277Ware 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.
PubMed 8628042Wright 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.
PubMed 18075447Doty 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.
PubMed 6463130
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Posterior Septectomy and Stamm Approach to Endoscopic Pituitary Adenoma Resection: A Randomized, Single-blind Trial
- ClinicalTrials.gov ID
- NCT01689064
- Acronym / sponsor ID
- E-24588
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior Septectomy | Active comparator | Procedure: Posterior SeptectomyPatient 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. |
| Stamm Approach | Experimental | Procedure: Stamm ApproachPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years old
- Diagnosis of a pituitary adenoma requiring resection defined as pituitary lesion with any of the following:
- Patient electing endoscopic resection approach
Key exclusion criteria (3 listed)
- Concurrent chronic rhinosinusitis
- Revision pituitary adenoma resections
- Severe medical co-morbidities with the inability to undergo general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stamm Approach | Procedure or surgery | Stamm Approach |
| Posterior Septectomy | Procedure or surgery | Posterior Septectomy |
Primary outcome
Change in Quality of Life
Time frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
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.
4 secondary outcomes
Change in Symptom Score
Time frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
Change in Utility Score
Time frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
Change in Endoscopic Sinus Score
Time frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
Change in Olfaction
Time frame: Pre-operative and Post-operative (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Background: PubMed 16968795Daly 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.
- Background: PubMed 8154641Hall 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.
- Background: PubMed 21474686Freda 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.
- Background: PubMed 20578228Rotenberg 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.
- Background: PubMed 22252670DeKlotz 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.
- Background: PubMed 22287427Oosmanally 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.
- Background: PubMed 19810602Graham 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.
- Background: PubMed 22287366Suberman 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.
- Background: PubMed 18359368Stamm 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.
- Background: PubMed 22038032Little 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.
- Background: PubMed 19793277Hopkins 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.
- Background: PubMed 8628042Ware 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke Rudmik, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stamm Approach and Posterior Septectomy in people with Pituitary Adenoma and Posterior Septectomy, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (time frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01689064, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.