Nasal Packing Following Endoscopic Endonasal Pituitary Resection
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|ClinicalTrials.gov Identifier: NCT03677713|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : May 28, 2020
There is considerable controversy about the use of nasal packing following endoscopic endonasal resection of pituitary tumors as a necessary treatment amongst Rhinology-Skull Base Surgeons. The justification for the routine use of nasal packing following pituitary surgery is not clear as this practice is not used for equally extensive sinus surgery. Further scientific evidence supporting this practice is lacking, and a recent survey of Canadian surgeons performing this surgery demonstrates clear division in practice for the routine use of nasal packing. Nasal packing causes patients significant discomfort requiring medication, and the use of packing adds direct and unintended hospitalization and health system costs for every case for which it is used. The benefits, short-comings, and associated costs of nasal packing following endoscopic endonasal transsphenoidal pituitary resection have not been studied.
OBJECTIVE: To determine if nasal packing following endoscopic endonasal pituitary tumor surgery is a necessary treatment. The principal research questions for this study, our internal pilot of the RCT, pertain to feasibility of enrolment of patients undergoing endoscopic endonasal transsphenoidal pituitary tumor surgery using the full RCT protocol of nasal packing versus no nasal packing. The pilot will address feasibility of site-specific enrolment and feasibility of institutional ethics approval and protocol administration.
|Condition or disease||Intervention/treatment||Phase|
|Pituitary Tumor||Procedure: No nasal packing. Procedure: Nasal Packing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A single center, non-blinded, randomized controlled trial (RCT) will be conducted as a pilot study.|
|Masking:||None (Open Label)|
|Official Title:||Nasal Packing Following Endoscopic Endonasal Pituitary Resection|
|Actual Study Start Date :||January 20, 2019|
|Estimated Primary Completion Date :||November 20, 2021|
|Estimated Study Completion Date :||April 30, 2022|
Active Comparator: Nasal Packing
Nasal packing will be placed at the end of surgery.
Procedure: Nasal Packing
Patients will have nasal packing at the end of the surgery
Experimental: No Nasal Packing
No nasal packing will be placed during or after the surgery.
Procedure: No nasal packing.
No nasal packing at the end of the surgery
- Anterior Skull Basal Nasal Inventory-12 (ASK-12) [ Time Frame: Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4 ]The ASK-12 is a validated patient reported nasal QOL questionnaire that evaluates morbidity after endonasal skull base surgery. Twelve symptoms related to nasal health are scored 0-5 and a global score is the mean value. Lower scores reflect better sinonasal quality of life.
- Incidence of sinonasal adverse events [ Time Frame: Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4 ]Evaluated by comparing the proportion of patients in each group who develop any sinonasal adverse events ( epistaxis, sinusitis, synechia, CSF rhinorrhea, nasal septal perforation
- Change in EuroQual-5Dimension (EQ-5D) [ Time Frame: Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4 ]Quality of Life Survey
- Cost Analysis [ Time Frame: Through study completion, 1 year. ]An analysis of the direct and indirect costs related to hospitalization and medication use.
- Change in Analgesic and Antibiotic Usage [ Time Frame: Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4 ]The total amount (dosage) of analgesic and antibiotics administered during the study period.
- Post operative pain [ Time Frame: Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4 ]Will be captured using a visual analogue scale (VAS). Scores range from 0 to 10. Lower score indicate less severe pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677713
|Contact: Andrea L Lasso, M.Sc.||613-798-5555 ext firstname.lastname@example.org|
|Contact: Corliss Best, MD||613-737-8899 ext email@example.com|
|The Ottawa Hospital||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Contact: Andrea Lasso, MSc 6137985555 ext 10222 firstname.lastname@example.org|
|Principal Investigator:||Shaun Kilty, MD||The Ottawa Hospital|