An observational study in Pituitary Neoplasm, Pituitary Adenoma and Prolactinoma, sponsored by St. Joseph's Hospital and Medical Center, Phoenix. Completed at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-22.
Sponsored by St. Joseph's Hospital and Medical Center, Phoenix · Observational
This is a prospective, multi-center observational study designed to address patient-reported nasal outcomes in adults undergoing endoscopic and microscopic surgical removal of pituitary tumors. The primary objective of this study is to determine the difference in nasal outcomes by using the Anterior Skull Base (ASK) Nasal survey between patients treated with endoscopic surgical technique and those treated with microscopic surgical technique. Patients will be given the ASK Nasal survey to assess their nasal functioning and overall health before their surgery, and at post-operative visits 1-2 weeks, 3 months, and 6 months.
The technical and patient factors that influence rhinological (nasal) outcomes following endonasal anterior skull base surgery and pituitary surgery are not well understood. Several timely and controversial topics, such as the influence of endoscopic techniques and the impact of underlying disease on nasal outcomes are in need of further study.
The Anterior Skull Base (ASK) Nasal survey is a 24-item questionnaire designed to assess for common postoperative nasal complaints, such as crusting, nasal congestion, pain, sinusitis, sense of smell, and overall functioning. The survey is a brief and simple assessment that asks patients to score symptom severity on a five-point scale.
28 studies on the registry are indexed under Prolactinoma; 5 are open to participants now.
This study's enrollment of 235 is below the median of 530 across 13 observational studies indexed under Prolactinoma.
Browse Prolactinoma studies →St. Joseph's Hospital and Medical Center, Phoenix is the lead sponsor of 63 studies on the registry; 10 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Compared within Prolactinoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pituitary Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with pituitary lesions referred to our investigators for surgical management by either microscopic or endoscopic transspenoidal surgical resection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Microscopic (single nostril, direct endonasal with nasal speculum)transsphenoidal nasal surgery
Fully endoscopic: (bi-nostril, no nasal speculum) transsphenoidal pituitary surgery
ASK Nasal symptom severity scores and SF-8 scores
Compare symptom severity scores and quality of life scores in first-time surgery patients with nonfunctioning adenomas on the ASK Nasal and SF-8.
Time frame: 3 months
Validation of ASK Nasal survey tool
Validate a nasal outcomes scale (ASK Nasal) specifically designed for anterior skull base surgery.
Time frame: 3 months
ASK Nasal symptom severity scores
* Evaluate the symptom severity scores on the ASK Nasal for first time surgery patients with nonfuctioning adenomas at the first post-operative visit and at 6 months. * Evaluate the symptom severity scores on the ASK Nasal for all patients at the first post-operative visit and at 6 months.
Time frame: 2 weeks, 3 months, 6 months postoperative
Impact of surgical techniques and complications on ASK Nasal scores
* Subgroup analysis on the impact of such surgical techniques, such as middle turbinate resection and nasal packing, on ASK Nasal scores will be performed. * Subgroup analysis of rhinological complications, such as sinusitis, on ASK Nasal scores. * Objective intranasal endoscopy findings at follow-up visits.
Time frame: 6 months
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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St. Joseph's Hospital and Medical Center, Phoenix