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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
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Cost Analysis [ Time Frame: Through study completion, 1 year. ]
    An analysis of the direct and indirect costs related to hospitalization and medication use.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • undergoing endoscopic endonasal transsphenoidal approach to pituitary resection for pituitary tumors of any pathology for the first time

Exclusion Criteria:

  • patients who do not have a working understanding of English
  • patients with known allergy to Merocel nasal packing

Information from the National Library of Medicine

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


Contacts
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Contact: Andrea L Lasso, M.Sc. 613-798-5555 ext 10222 alasso@toh.ca
Contact: Corliss Best, MD 613-737-8899 ext 72968 cbest@toh.ca

Locations
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Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Andrea Lasso, MSc    6137985555 ext 10222    alasso@toh.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
The Physicians' Services Incorporated Foundation
Investigators
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Principal Investigator: Shaun Kilty, MD The Ottawa Hospital
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03677713    
Other Study ID Numbers: 20180541-01H
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
endoscopic
endonasal
transsphenoidal
surgical resection
pituitary tumour
nasal packing
Merocel
Additional relevant MeSH terms:
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Pituitary Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms