Quality of Life Clinical Trial
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.
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, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT06238557 -
Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
|
||
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT05472935 -
Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers
|
N/A | |
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04281953 -
Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
|
||
Recruiting |
NCT05546931 -
Mobile Health Program for Rural Hypertension
|
N/A | |
Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Recruiting |
NCT04142827 -
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
|
N/A | |
Active, not recruiting |
NCT05903638 -
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT03813420 -
Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level
|
N/A | |
Recruiting |
NCT05550545 -
Infant RSV Infections and Health-related Quality of Life of Families
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Recruiting |
NCT05233020 -
Robotic Versus Hybrid Assisted Ventral Hernia Repair
|
N/A | |
Terminated |
NCT03304184 -
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
|
Phase 3 | |
Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
Recruiting |
NCT05380856 -
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
|
N/A |